Perfluoro-n-Butyl Iodide: Acute Toxicity, Subchronic Toxicity and                Genotoxicity Evaluations

Perfluoro-n-butyl iodide (PFBI) is a promising alternative to chlorofluorocarbon solvents used in aircraft ground maintenance operations and other military and commercial operations, because it cleans well, has zero ozone depletion potential, and has extremely low global warming properties. Toxicity tests were performed with PFBI to determine and evaluate its health hazard. Using standard testing guidelines (e.g., Organization for Economic Cooperation and Development [OECD]), tests included acute (4-h) and 4-week (6 h/day, 5 days/week) inhalation (nose-only) toxicity studies in rats, acute (10-min) inhalation cardiac sensitization study in dogs, in vitro chromosomal aberrations experiments in human lymphocytes, and in vitro mutagenic experiments in Salmonella typhimurium and Escherichia coli. There were no mortalities in rats ( n = 10) exposed for 4 h to 10,000 ppm PFBI, but all rats ( n = 10) died within 2 h when exposed to 20,000 ppm PFBI. The 4-h LC50 (95% confidence limits) was 14,000 ppm (13,000 ppm to 16,000 ppm). Signs (nasal discharge and labored breathing) observed in the rats exposed to 10,000 ppm returned to normal within 48 h. PFBI has the potential to cause cardiac sensitization in epinephrine-challenged dogs at 6200 ppm. A concentration of 3900 ppm was a no-observed-adverse-effect level (NOAEL) in the cardiac sensitization study. In the 4-week inhalation study (5 rats/sex/group), respiratory mucosal hypertrophy/hyperplasia was observed in rats of the 10,000-ppm group. A NOAEL of 1000 ppm was selected for the 4-week study on the basis that the mild increase in T4 observed at 1000 ppm was considered adaptive, not adverse, because of the absence of frank effects in the thyroid. In the in vitro studies, PFBI showed no evidence of either mutagenic or clastogenic activity. The toxicity profile of PFBI was compared to trifluoroiodomethane. In conclusion, the results of these studies indicate a low order of general toxicity and an absence of genotoxicity following PFBI exposure.

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Safety Assessment of Ubiquinol Acetate: Subchronic Toxicity and Genotoxicity Studies

Journal of Toxicology ◽

10.1155/2019/3680757 ◽

2019 ◽

Vol 2019 ◽

pp. 1-25

Author(s):

Gajanan Deshmukh ◽

Suresh B. Venkataramaiah ◽

Chandrashekar M. Doreswamy ◽

Mohan C. Umesh ◽

Rajesh B. Subbanna ◽

...

Keyword(s):

Biologically Active ◽

High Dose ◽

Sprague Dawley ◽

Subchronic Toxicity ◽

Sprague Dawley Rats ◽

Adverse Effect Level ◽

Effect Level ◽

Endogenous Antioxidant ◽

In Vitro Genotoxicity

Coenzyme Q10 (CoQ10) is a lipid soluble, endogenous antioxidant present at highest levels in the heart followed by the kidney and liver. The reduced CoQ10 ubiquinol is well known for its chemical instability and low bioavailability. The present study was designed to synthesize ubiquinol acetate, which is more stable and biologically active, and further evaluate its safety and genotoxic potential. Synthesized ubiquinol acetate showed better stability than that of ubiquinol at the end of 3 months. In vitro genotoxicity studies (AMES test, in vitro micronucleus and chromosomal aberration) showed ubiquinol acetate as nongenotoxic with no clastogenic or aneugenic effects at high dose of 5000 and 62.5 μg/mL, respectively. In subchronic toxicity study, ubiquinol acetate was administered orally to Sprague Dawley rats at 150, 300, and 600 mg/kg/day for 90 days. No treatment related adverse effects were observed in males at 600 mg/kg/day; however, females showed treatment related increase in AST and ALT with small focal irregular white-yellow spots in liver on gross necropsy examination. Histopathological evaluation revealed hepatocellular necrosis in high dose females which was considered as adverse. Based on the results, the No-Observed-Adverse-Effect Level (NOAEL) of ubiquinol acetate in males and females was determined as 600 and 300 mg/kg/day, respectively.

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Safety Evaluation of a Proprietary Food-Grade, Dried Fermentate Preparation of Saccharomyces cerevisiae

International Journal of Toxicology ◽

10.1177/1091581811425195 ◽

2012 ◽

Vol 31 (1) ◽

pp. 34-45 ◽

Cited By ~ 2

Author(s):

Alexander G. Schauss ◽

R. Glavits ◽

John Endres ◽

Gitte S. Jensen ◽

Amy Clewell

Keyword(s):

Saccharomyces Cerevisiae ◽

Clinical Symptoms ◽

Safety Evaluation ◽

In Vivo Studies ◽

Oral Toxicity ◽

Toxicity Studies ◽

Adverse Effect Level ◽

Effect Level

A safety evaluation was performed for EpiCor, a product produced by a proprietary fermentation process using Saccharomyces cerevisiae. Studies included the following assays: bacterial reverse mutation, mouse lymphoma cell mutagenicity, mitogenicity assay in human peripheral lymphocytes, and a cytochrome P450 ([CYP] CYP1A2 and CYP3A4) induction assessment as well as 14-day acute, 90-day subchronic, and 1-year chronic oral toxicity studies in rats. No evidence of genotoxicity or mitogenicity was seen in any of the in vitro or in vivo studies. The CYP assessment showed no interactions or inductions. No toxic clinical symptoms or histopathological lesions were observed in the acute, subchronic, or chronic oral toxicity studies in the rat. Results of the studies performed indicate that EpiCor does not possess genotoxic activity and has a low order of toxicity that is well tolerated when administered orally. The no observable adverse effect level (NOAEL) was 1500 mg/kg body weight (bw)/d for the 90-day study and 800 mg/kg bw/d for the 1 year study, for the highest doses tested.

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Subchronic and Developmental Toxicity of Aromatic Extracts

International Journal of Toxicology ◽

10.1177/1091581813517724 ◽

2014 ◽

Vol 33 (1_suppl) ◽

pp. 136S-155S ◽

Cited By ~ 5

Author(s):

Walden E. Dalbey ◽

Richard H. McKee ◽

Katy Olsavsky Goyak ◽

Jeffrey H. Charlap ◽

Craig Parker ◽

...

Keyword(s):

Aromatic Compounds ◽

Developmental Toxicity ◽

Reproductive Toxicity ◽

Biologically Active ◽

Toxicity Tests ◽

Multiple Organs ◽

Petroleum Fractions ◽

Adverse Effect Level ◽

Effect Level

Aromatic extracts (AEs; distillate AEs [DAEs] and residual AEs [RAEs]) are complex, highly viscous liquid petroleum streams with variable compositions derived by extraction of aromatic compounds from distillate and residual petroleum fractions from a vacuum distillation tower, respectively. The DAEs generally contain significant amounts of polycyclic aromatic compounds (PACs) and are carcinogenic. The RAEs typically contain lower concentrations of biologically active PACs. The PACs in refinery streams can cause effects in repeated-dose and developmental toxicity studies. In a 13-week dermal study, light paraffinic DAE had several dose-related effects involving multiple organs; no-observed-effect level was <5 mg/kg/d, with no overt toxicity. Predicted dose-responses at 10% (PDR10s), modeled doses causing a 10% effect on sensitive end points based on PAC content, ranged from 25 to 78 mg/kg/d for untested paraffinic DAEs. The no observed adverse effect level (NOAEL) for developmental toxicity for light paraffinic DAE was 5 mg/kg/d. Statistically significant developmental effects at higher doses were associated with maternal effects. The PDR10s for developmental toxicity of paraffinic DAEs ranged from 7 to >2000 mg/kg/d, reflecting differences due to variation in PACs. The NOAELs for RAEs were 500 mg/kg for 90-day studies and 2000 mg/kg for developmental toxicity. Reproductive toxicity is not considered to be a sensitive end point for AEs based on the toxicity tests with DAEs, RAEs, and other PAC-containing petroleum substances. In vivo micronucleus tests on heavy paraffinic DAE, RAEs, and a range of other petroleum substances have been negative. The exception to this general trend was a marginally positive response with light paraffinic DAE. Most DAEs are considered unlikely to produce chromosomal effects in vivo.

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A 90-day toxicity and genotoxicity study with high-purity phenylcapsaicin

Toxicology Research and Application ◽

10.1177/2397847318773060 ◽

2018 ◽

Vol 2 ◽

pp. 239784731877306 ◽

Cited By ~ 1

Author(s):

Torbjørn Rage Paulsen ◽

Sebastian Stiller ◽

Klaus Weber ◽

Claudia Donath ◽

Gudrun Schreiband ◽

...

Keyword(s):

Clinical Symptoms ◽

Clinical Chemistry ◽

Human Lymphocytes ◽

Recovery Period ◽

Clinical Signs ◽

Gene Mutations ◽

Oral Gavage ◽

Adverse Effect Level ◽

Dose Oral ◽

Effect Level

To evaluate the safety of the synthetic capsaicin analogue phenylcapsaicin (PheCap; 7-phenylhept-6-yne-acid-hydroxy-3-mathoxylbenzylamide, CAS no 848127-67-3), a 90-day repeated dose oral gavage of 0, 30, 100 or 250 mg/kg body weight (bw)/day toxicity study with a 28-day recovery period was conducted using Wistar rats. Examinations of clinical signs, body and organ weight, haematology, urinalysis, clinical chemistry, food consumption and macroscopic, as well as histopathological tissue examinations were carried out for signs of toxicity. Degenerative, but reversible changes in the liver at 250 mg/kg bw/day, and local irritating effects in the stomach at 100 and 250 mg/kg bw/day were found. These findings were associated with test item-related clinical symptoms, that is, diarrhoea, salivation and moving of bedding material. PheCap did neither cause gene mutations by base pair changes or frame shifts in the genome of the tester stains Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 or TA 102 nor induce structural and/or numerical chromosomal damage in human lymphocytes. Therefore, it can be concluded that PheCap is not genotoxic. The No Observed Adverse Effect Level (NOAEL) of PheCap for systemic toxicity is considered to be at 100 mg/kg bw/day which is based on degenerative changes in the liver. Due to irritating effects in the stomach, the NOAEL for local effects was established at 30 mg/kg bw/day.

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Assessment of the potential health hazard of fibrous glaucophane

10.5194/egusphere-egu2020-5356 ◽

2020 ◽

Author(s):

Dario Di Giuseppe ◽

Alessandro Gualtieri ◽

Alessandro Zoboli ◽

Monica Filaferro ◽

Giovanni Vitale ◽

...

Keyword(s):

Health Hazard ◽

Toxicity Tests ◽

International Agency ◽

Potential Toxicity ◽

Potential Health ◽

Franciscan Complex ◽

Mineral Fibre ◽

Potential Health Hazard

The widespread concern on the environmental hazards and public health issues related to exposure to respirable dusts from naturally occurring asbestos (NOA) in principle should also apply to deposits of mineral fibres other than the currently regulated six asbestos minerals. Recent studies highlight that glaucophane can assume a fibrous habit resembling the regulated amphibole asbestos minerals. Glaucophane, sometimes occurring in a fibrous habit, is a major mineral component of blueschist rocks of the Franciscan Complex, USA. Recently, fibrous blueschist occurrences within the Franciscan Complex were being excavated in California for construction purposes (e.g., the Calaveras Dam Replacement Project) and concern existed that the dust generated by the excavation activities might potentially expose workers and the general public to health risks. For this reason, fibrous glaucophane (Gla) was considered to represent a potential health hazard as NOA by the dam owner, the San Francisco Public Utilities Commission, though an evaluation of the potential health hazard of this mineral fibre was not mandatory per local state and federal regulations. To fill this gap, the potential toxicity/pathogenicity of Gla from the Franciscan Complex has been assessed using the fibre potential toxicity model (FPTI) model and specific in vitro toxicity tests. FPTI is an analytical tool to predict the toxicity/pathogenicity of minerals &#64257;bers, based on physical/chemical and morphological parameters that induce biochemical mechanisms responsible for in vivo adverse effects. This model delivers an FPTI index aimed at ranking the toxicity and pathogenicity of a mineral fibre. Compared to asbestos minerals, the FPTI of Gla is considerably higher than that of chrysotile, comparable to that of tremolite and lower than that of crocidolite. Biological responses of cultured human lung cells (THP-1 and Met-5A) following 24 and 48h of exposure to different doses of Gla (25, 50 and 100 &#181;g/mL), have been determined by Alamar Blue viability, Extra-cellular lactate dehydrogenase (LDH) and Comet assays. Generation of reactive oxygen species (ROS) has been evaluated performing the luminescent ROS-Glo&#8482; assay. Crocidolite UICC asbestos (100 &#181;g/mL) was also tested for comparison. Results of in vitro tests showed that Gla may induce a decrease in cell viability and an increase in LDH release in tested cell cultures in a concentration dependent mode. Overall, the rank of the investigated fibres in increasing order of cytotoxicity is: Gla (25 &#956;g/mL) < Gla (50 &#956;g/mL) < crocidolite (50 &#956;g/mL) < Gla (100 &#956;g/mL). For both the cells lines, Gla was able to induce DNA damage. Moreover, it was found that Gla can induce the formation of ROS. The chemical-structural features and biological reactivity of Gla confirm that this mineral fibre is a toxic agent. Although Gla induced lower toxic effects compared to the carcinogenic crocidolite, the inhalation of its fibres may be hypothetically responsible for the development of lung diseases. For a conclusive understanding of the mechanisms of the cellular/tissues responses to fibrous glaucophane, in vivo animal tests should be performed and compared to our outcome to stimulate a critical evaluation and a classification by the International Agency for Research on Cancer (IARC).

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Trifluoroiodomethane (CF3I) (2019)

Toxicology and Industrial Health ◽

10.1177/0748233720930549 ◽

2020 ◽

Vol 36 (5) ◽

pp. 310-321

Keyword(s):

Adverse Effect ◽

Thyroid Hormone ◽

Weighted Average ◽

High Dose ◽

Exposure Level ◽

Inhalation Toxicity ◽

Inhalation Study ◽

Short Term Exposure ◽

Adverse Effect Level ◽

Effect Level

Trifluoroiodomethane (CF3I) is a colorless and odorless gas used primarily as a fire suppressant. CF3I has low acute inhalation toxicity. The no-observed adverse effect level (NOAEL) of CF3I for cardiac sensitization in dogs was 2000 ppm. The potential effects of 4-week inhalation exposure in both rats and mice have been examined. In rats, the NOAEL was 10,000 ppm, and in mice, the NOAEL was 10,000 ppm. In a subchronic inhalation study in rats, the lowest observed adverse effect level (LOAEL) was 20,000 ppm for thyroid-related effects; the study NOAEL (for non-thyroid-related effects) was 20,000 ppm. In a reproductive/developmental inhalation toxicity study in rats, 20,000 ppm CF3I produced minimal general toxicity and no indication of reproductive or developmental toxicity. The LOAEL for parental toxicity (based on thyroid hormone effects) was 2000 ppm; excluding thyroid effects, the parental NOAEL was 7000 ppm CF3I. The observed effects on the thyroid in rats were considered of less relevance to human risk assessment than the other observed systemic effects because of known species-specific differences in sensitivity to thyroid hormone perturbations. There are no chronic toxicity or carcinogenicity studies available. CF3I had mixed results in various in vitro and in vivo genotoxicity assays. The NOAEL of 7000 ppm from the reproductive/developmental inhalation study was used as the point of departure (POD) for workplace environmental exposure level (WEEL) value development. This POD was adjusted to account for interindividual variability, duration of exposure, and database limitations. The resulting 8-h time-weighted average WEEL value of 500 ppm is expected to provide a significant margin of safety against any potential adverse health effects in workers exposed to CF3I. A 15-min short-term exposure limit of 1500 ppm was also established to protect workers from potential cardiac effects produced by acute, high-dose inhalation of CF3I.

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Comparative cytotoxicity and genotoxicity of cobalt (II, III) oxide, iron (III) oxide, silicon dioxide, and aluminum oxide nanoparticles on human lymphocytes in vitro

Human & Experimental Toxicology ◽

10.1177/0960327115579208 ◽

2015 ◽

Vol 35 (2) ◽

pp. 170-183 ◽

Cited By ~ 46

Author(s):

S Rajiv ◽

J Jerobin ◽

V Saranya ◽

M Nainawat ◽

A Sharma ◽

...

Keyword(s):

Dna Damage ◽

Aluminum Oxide ◽

Silicon Dioxide ◽

Chromosomal Aberration ◽

Human Lymphocytes ◽

Human Health Risk ◽

Membrane Damage ◽

Toxicity Tests ◽

Dependent Manner

Despite the extensive use of nanoparticles (NPs) in various fields, adequate knowledge of human health risk and potential toxicity is still lacking. The human lymphocytes play a major role in the immune system, and it can alter the antioxidant level when exposed to NPs. Identification of the hazardous NPs was done using in vitro toxicity tests and this study mainly focuses on the comparative in vitro cytotoxicity and genotoxicity of four different NPs including cobalt (II, III) oxide (Co3O4), iron (III) oxide (Fe2O3), silicon dioxide (SiO2), and aluminum oxide (Al2O3) on human lymphocytes. The Co3O4 NPs showed decrease in cellular viability and increase in cell membrane damage followed by Fe2O3, SiO2, and Al2O3 NPs in a dose-dependent manner after 24 h of exposure to human lymphocytes. The oxidative stress was evidenced in human lymphocytes by the induction of reactive oxygen species, lipid peroxidation, and depletion of catalase, reduced glutathione, and superoxide dismutase. The Al2O3 NPs showed the least DNA damage when compared with all the other NPs. Chromosomal aberration was observed at 100 µg/ml when exposed to Co3O4 NPs and Fe2O3 NPs. The alteration in the level of antioxidant caused DNA damage and chromosomal aberration in human lymphocytes.

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Cis-1,1,1,4,4,4-hexafluoro-2-butene (HFO-1336mzz-Z) (2018)

Toxicology and Industrial Health ◽

10.1177/0748233719825530 ◽

2019 ◽

Vol 35 (3) ◽

pp. 180-188 ◽

Cited By ~ 2

Keyword(s):

Body Weight ◽

Food Consumption ◽

Body Weight Gain ◽

Inhalation Exposure ◽

Individual Variability ◽

Repeat Dose ◽

Inhalation Study ◽

Reduced Body ◽

Adverse Effect Level ◽

Effect Level

Cis-1,1,1,4,4,4-hexafluoro-2-butene (HFO-1336mzz-Z) is a clear, colorless liquid that finds uses as a foam-blowing agent, refrigerant, fire extinguishing agent, and solvent. HFO-1336mzz-Z is not an acute dermal or eye irritant and has very low acute toxicity via inhalation exposure (4-h lethal concentration (LC50) > 102,000 ppm). The no-observed adverse effect level (NOAEL) and lowest-observed adverse effect level (LOAEL) for cardiac sensitization (in epinephrine-challenged dogs) were 12,500 ppm and 25,000 ppm, respectively. In a GLP, subacute (4-week) repeat-dose inhalation study in Crl: CD(SD) male and female rats at exposure concentrations of 0, 2500, 5000, or 10,000 ppm, the only significant observations attributed to exposure were reduced body weight, reduced body weight gain, and reduced food consumption. The study NOAEL was determined to be 2500 ppm. Two separate GLP, 13-week repeat-dose inhalation studies (Organisation for Economic Cooperation and Development (OECD) 413) have been conducted on HFO-1336mzz-Z using male and female Crl: CD (SD) rats. In the first study, exposure concentrations were 0, 500, 1500, or 10,000 ppm, and in the second study, 0, 3000, 4000, 5000, or 7500 ppm. The only significant exposure-related observations in the first study were reductions in body weights, food consumption, and food efficiency in males and females at 10,000 ppm (study NOAEL = 1500 ppm). In the second study, done in part to better define the NOAEL, reductions in body weight and food consumption were observed in males at 7500 ppm; there were no exposure-related observations on these end points in females. Therefore, the study NOAEL was established at 5000 ppm for males and 7500 ppm for females. HFO-1336mzz-Z has also been examined for its potential to produce developmental toxicity in both Crl: CD(SD) rats (0, 500, 1500, or 10,000 ppm) and New Zealand White rabbits (0, 2500, 5000, 7500, or 15,000 ppm) according to GLP and OECD 414. The NOAEL for both maternal and fetal effects in rats was 1500 ppm and the NOAELs for maternal effects and fetal effects in rabbits were 5000 ppm and 7500 ppm, respectively. A non-GLP, two-generation reproductive pilot study, for a planned multigenerational study noted reduced body weight and body weight gain in males at 1500 ppm and above; the NOAEL for this pilot study was set at 500 ppm. There are no chronic toxicity/carcinogenicity studies available, and HFO-1336mzz-Z was not genotoxic/mutagenic in in vitro and in vivo studies. The NOAEL for male rats of 5000 ppm (based on reductions in body weight and food consumption) from the 13-week inhalation study was selected as the point of departure for the derivation of the 8-h time-weighted average (TWA), health-based workplace environmental exposure level (WEEL) value. This subchronic inhalation NOAEL was adjusted to account for duration of exposure, inter-individual variability, and intra-individual variability. The resulting 8-h TWA WEEL value of 500 ppm is fully expected to provide a significant margin of safety against the production of any potential adverse health effects in workers following long-term inhalation exposure to HFO-1336mzz-Z vapor.

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UJI TOKSISITAS ORAL REPEATED DOSE FILTRAT BUAH LUWINGAN (Ficus hispida L.f.) MENGGUNAKAN MODEL TIKUS (Rattus norvegicus Berkenhout, 1769) GALUR WISTAR

BERITA BIOLOGI ◽

10.14203/beritabiologi.v19i3a.3936 ◽

2020 ◽

Vol 19 (3A) ◽

Author(s):

Laksmindra Fitria ◽

Rosita Dwi Putri Suranto ◽

Indira Diah Utami ◽

Septy Azizah Puspitasari

Keyword(s):

Adverse Effect ◽

Toxicity Test ◽

Sublethal Effects ◽

Complete Blood Count ◽

Repeated Dose ◽

Toxicity Tests ◽

Oral Toxicity ◽

Food Ingredient ◽

Adverse Effect Level ◽

Effect Level

Hairy fig is a tropical medium-sized tree that produces abundant fruits throughout the year. In some Asian countries, the fruits are consumed as traditional medicine and food ingredient. Meanwhile in Indonesia there has not been much use. A series of oral toxicity tests must be conducted to study the possibility of toxic effects and the safety before further exploration. Oral single dose toxicity study of young and ripe hairy fig fruit filtrate has been carried out. Results demonstrated no observed adverse effect level (NOAEL) at a concentration of 100%. This study was aimed to continue the oral toxicity test with repeated dose following standard toxicity procedure by OECD Test Guideline No. 407 with some modifications. Parameters observed were mortality, sublethal effects consisted of physical conditions and behavior, body weight, core temperature, complete blood count, as well as liver, heart, and renal functions by measuring ALT, AST, and creatinine, respectively. Sampling points on day 0, 7, 14, 21, and 28. Results showed no observed adverse effect level (NOAEL) in both young and ripe fruits filtrate at a concentration of 100% however with a tendency to cause anemia and associate with renal dysfunction. Therefore, it is necessary to perform similar method of toxicity test but with lower concentration, also continue with further toxicity tests (subchronic and chronic periods).

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Final Amended Report on the Safety Assessment of Ammonium Thioglycolate, Butyl Thioglycolate, Calcium Thioglycolate, Ethanolamine Thioglycolate, Ethyl Thioglycolate, Glyceryl Thioglycolate, Isooctyl Thioglycolate, Isopropyl Thioglycolate, Magnesium Thioglycolate, Methyl Thioglycolate, Potassium Thioglycolate, Sodium Thioglycolate, and Thioglycolic Acid

International Journal of Toxicology ◽

10.1177/1091581809339890 ◽

2009 ◽

Vol 28 (4_suppl) ◽

pp. 68-133 ◽

Cited By ~ 7

Author(s):

Christina L. Burnett ◽

Wilma F. Bergfeld ◽

Donald V. Belsito ◽

Curtis D. Klaassen ◽

James G. Marks ◽

...

Keyword(s):

Safety Assessment ◽

Thioglycolic Acid ◽

Developmental Toxicity ◽

In Vitro Tests ◽

Oral Toxicity ◽

Adverse Effect Level ◽

Effect Level ◽

Clinically Significant ◽

Skin Irritants

This safety assessment includes Ammonium and Glyceryl Thioglycolate and Thioglycolic Acid Butyl, Calcium, Ethanolamine, Ethyl, Isooctyl, Isopropyl, Magnesium, Methyl, Potassium, and Sodium Thioglycolate, as used in cosmetics. Thioglycolates penetrate skin and distribute to the kidneys, lungs, small intestine, and spleen; excretion is primarily in urine. Thioglycolates were slightly toxic in rat acute oral toxicity studies. Thioglycolates are minimal to severe ocular irritants. Thioglycolates can be skin irritants in animal and in vitro tests, and can be sensitizers. A no-observable-adverse-effect level for reproductive and developmental toxicity of 100 mg/kg per day was determined using rats. Thioglycolates were not mutagenic, and there was no evidence of carcinogenicity. Thioglycolates were skin irritants in some clinical tests. Clinically significant adverse reactions to these ingredients used in depilatories are not commonly seen, suggesting current products are formulated to be practically nonirritating under conditions of recommended use. Formulators should take steps necessary to assure that current practices are followed.

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