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EC number: 201-180-5 | CAS number: 79-14-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study initiated on 16 October 1995. Study completed on 20 June 1996.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
- Remarks:
- Test doses in the present study determined after pilot study summarised in the cross-reference
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
- Reference Type:
- publication
- Title:
- Developmental Toxicity Study of Glycolic Acid in Rats
- Author:
- Munley SM, Kennedy GL, Hurtt ME
- Year:
- 1 989
- Bibliographic source:
- Drug and Chemical Toxicology, 22(4), 569-582
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Directive 87/302/EEC (OJ No L133 31.5.88)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-3 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MAFF NohSan 59, No. 4200.
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Glycollic acid
- EC Number:
- 201-180-5
- EC Name:
- Glycollic acid
- Cas Number:
- 79-14-1
- Molecular formula:
- C2H4O3
- IUPAC Name:
- 2-hydroxyacetic acid
- Details on test material:
- Glycolic acid >99%
Constituent 1
- Specific details on test material used for the study:
- 99.6% purity.
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD.BR
- Remarks:
- The rat was selected to provide data in a rodent species. The Crl:CD BR strain was chosen because historical control data are available from the literature, the supplier, and previous studies at the laboratory.
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, North Carolina.
- Age at study initiation: Males were 77 days old on arrival and females were 63 days old on arrival.
- Weight at study initiation: Males weighed between 306.1 and 371.6 g on arrival and females weighed between 180.6 and 230.5 g on arrival.
- Fasting period before study: N/A
- Housing: The rats were housed individually in suspended, wire-mesh, stainless steel cages. Nesting material was not provided because the dams were euthanized prior to expected parturition.
- Diet (e.g. ad libitum): The rats were provided Purina Certified Rodent Chow@ #5002 (Meal) ad libitum.
- Water (e.g. ad libitum): The rats were supplied with tap water from United Water Delaware ad libitum.
- Acclimation period: All animals were quarantined for at least 6 days and then released for the study by the laboratory veterinarian.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 1°C.
- Humidity (%): 50 +/- 10%.
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark with fluorescent lighting.
IN-LIFE DATES: From: 16 October 1995 (first day of dosing) To: 4 December 1995 (last fetal evaluation).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Solutions of the test material in deionized water were prepared weekly during the study and stored in the refrigerator. Sufficient amounts of solution needed for dose administration were removed from the refrigerated containers daily.
Glycolic acid was administered by gavage because the oral route is a potential route of accidental human exposure. The dose volume was 10 mL/kg and individual dosages were based on the most recently recorded body weights. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples (-30 mL each) of each test solution were taken three times during the study: October 16, October 30, and November 6, 1995. Analysis of the first sampling addressed concentration and stability. For the second and third samplings, analyses addressed concentration. Samples were submitted to the Analytical Group of Environmental Sciences (ES) at Haskell Laboratory.
At the first sampling, two samples from the vehicle and each test solution were collected. One set of samples was submitted and analysed shortly after submission and the remaining samples were refrigerated for 7 days and then analysed for stability. At the second and third samplings, one sample of the vehicle and each test solution were analysed shortly after submission, to verify concentration. Analysis of glycolic acid in dosing formulations was conducted according to the following method.
Aliquots of the supplied dosing samples were pipetted into a beaker containing phenyl violet indicator/ice slurry. The volume of the aliquots varied based on the concentration of the supplied dosing samples. Targeted concentrations were 75 or 150 mg of glycolic acid for each titration. The aliquots were titrated with a standardised volumetric sodium hydroxide solution (0.251N - Baker Chemical) to the free acid equivalence point of the 99% glycolic acid. All glycolic acid samples were analysed the day they were prepared and submitted. - Details on mating procedure:
- - Impregnation procedure: cohoused.
- M/F ratio per cage: 1:1.
- Length of cohabitation: until copulation was confirmed. Mating began on October 9, 1995, with Gestational Day (GD) 1 occurring from October 10-13, 1995 and October 16-19, 1995.
- Proof of pregnancy: presence of a copulation plug in the vagina or on the cage board referred to as day 1 of gestation. - Duration of treatment / exposure:
- On days 7-21 of gestation (14 days). Females were euthanized on gestation day 22.
- Frequency of treatment:
- daily
- Duration of test:
- 14 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 600 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Dose / conc.:
- 75 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 25 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dose concentrations were based on the results of a rat pilot developmental toxicity study. In the pilot study, test concentrations of 70% technical solution were administered to groups of 8 bred rats over gestational days 7-21. Dose concentrations were 0, 125, 250, 500, and 1000 mg/kg bw. Maternal toxicity was demonstrated at 500 and 1000 mg/kg bw/day. At 1000 mg/kg bw/day, maternal effects included mortality, significantly reduced maternal body weights, weight changes and reduced food consumption. Dose-related increases of the following clinical observations were observed: abnormal gait and mobility, lung noise, salivation, stained and wet fur. At 500 mg/kg bw/day, similar, yet markedly less severe evidence of maternal toxicity was demonstrated and there was a slight but significant reduction in maternal weight gain. The incidences of lung noise and wet fur were significantly increased as well. Developmental toxicity was evident at 500 and 1000 mg/kg bw/day. At 1000 mg/kg bw/day, mean foetal weight was significantly reduced. Embryolethality was significantly increased and among the surviving foetuses, malformations and variations were significantly increased. At 500 mg/kg bw/day, the significant reduction in foetal weight persisted as did the increase in foetal variations. There was no evidence of either maternal or developmental toxicity at 250 or 125 mg/kg bw/day.
- Rationale for animal assignment (if not random): Before dosing began, females selected for the study that copulated during the first week of mating were ranked by their body weights on gestational day 1 and randomly assigned to control or experimental groups. Females selected from the second week of mating were similarly assigned. The randomization resulted in a distribution in which the mean body weights for all groups were not statistically different (p=0.9744). In addition to random assignment to groups, bias was controlled by coding all females prior to scheduled sacrifice. They remained coded during the collection of the post-mortem and foetal data.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS / DETAILED CLINICAL OBSERVATIONS: Yes
- Observations for morbidity and mortality were made daily.
- Individual clinical signs were recorded each morning on Days 1-22G and each afternoon on Days 7-21G (the dosing period).
BODY WEIGHT: Yes
- Time schedule for examinations: Females were weighed on Days 1 and 7-22G.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food was weighed on Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21 and 22G.
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 22
- Organs examined: the organs of the thoracic and abdominal cavities were examined for gross pathologic changes. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other:
- the types of implants (live and dead foetuses, and resorptions) were counted and their relative positions were recorded.
- the empty uterus was weighed. - Fetal examinations:
- Live foetuses were weighed, sexed, and examined for external alterations.
To identify stunted foetuses for each litter, the maximum stunted weight (MSW) was calculated by subtracting the lightest weight from the total weight, dividing by the remaining number of foetuses, and multiplying by 0.666. A foetus weighing less than or equal to the MSW was considered stunted. If the lightest foetus was determined to be stunted, the procedure was repeated until all remaining foetal weights were in excess of the MSW.
Retarded renal development was classified using the schema of Woo and Hoar.
- External examinations: Yes: all per litter.
- Soft tissue examinations: Yes: half per litter. The first live foetus and thereafter each alternate one removed subsequently was decapitated and examined for visceral alterations.
- Skeletal examinations: Yes: all per litter. All foetuses were fixed, stained (Alizarin red S) and examined for skeletal alterations.
- Head examinations: Yes: all per litter. - Statistics:
- Sequential trend testing was applied to the developmental toxicity data for each parameter as listed below. If a significant dose-response was detected, data from the top dose group was excluded and the test repeated until no significant trend was detected. For litter parameters, the proportion of affected foetuses per litter or the litter mean was the experimental unit for statistical evaluation. The level of significance selected was p<0.5. Where the data were tied and the standard large sample version of Jonckheere's test was not applicable, exact p values were calculated using permutation methodology.
Maternal weight, weight changes and food consumption: Linear contrast of means from ANOVA.
Live foetuses, dead foetuses, resorptions, nidations, copora lutea, incidence of foetal alterations: Jonckheere's test.
Incidence of pregnancy, clinical observations, maternal mortality, females with total resorptions early deliveries: Cochran-Armitage test.
Foetal weight, sex ratio: Linear contrast of least square means from ANCOVA. - Indices:
- N/A
- Historical control data:
- N/A
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- At 600 mg/kg bw/day, there were significantly increased incidences of adverse clinical observations; abnormal gait/mobility was observed in 5 of 25 dams at this level. Lung noise (wheezing and/or rattling after dosing which persisted into the afternoon and occasionally until the following day) and/or irregular respiration was seen in 8 of 25 dams. Two dams were lethargic. Lung noise similar to that observed at 600 mg/kg was observed in 2 of 25 dams dosed at 300 mg/kg. This incidence approached statistical significance (p=0.0553). No remarkable clinical observations were observed at 150 or 75 mg/kg bw/day.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Maternal body weights and weight changes were reduced at 600 mg/kg bw/day. Final body weight (Day 22G) and the final weight adjusted for the products of conception were significantly reduced. Statistically significant reductions in body weight changes were observed over Days 7-9,17-19, 19-21,21-22, and 7-22G. Weight changes calculated using the adjusted final body weight (final body weight minus the products of conception) were also significantly reduced (Days 7-22 and 1-22G). Maternal body weights, weight changes, and adjusted final body weights were unaffected at dose levels of 300 mg/kg bw/day and lower.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Maternal food consumption was significantly reduced at 600 mg/kg bw/day over Days 21-22G. Maternal food consumption was unaffected at dose levels of 300 mg/kg bw/day and lower.
- Food efficiency:
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- There were no significant post-mortem findings at any dose level.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- There were no dose-related effects on reproductive outcome parameters: dams with total resorptions, mean corpora lutea, mean number of implantations, litter size or sex ratio.
- Details on maternal toxic effects:
- N/A
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 300 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOEL
- Effect level:
- 150 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean foetal weight was significantly reduced at 600 mg/kg bw/day.
- Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Anogenital distance of all rodent fetuses:
- not examined
- Changes in postnatal survival:
- not specified
- External malformations:
- not specified
- Skeletal malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- The incidence of specific malformations was significantly increased at 600 mg/kg/day. These malformations were fused and absent ribs, fused and hemivertebra, and abnormally fused and cleft/non-fused sternebra. At 300 mg/kg, there was a slight increase in the incidence of two skeletal malformations, fused ribs and fused vertebra. The incidences for these findings, 2 foetuses from 2 litters, approached statistical significance (p=0.0555). There were no compound-related malformations at 150 or 75 mg/kg. The incidence of variations was increased at 600 mg/kg bw/day. The specific variations were misaligned and incompletely ossified sternebra and incompletely ossified vertebra. There were no increased foetal variations at 300 mg/kg bw/day and lower.
- Visceral malformations:
- not specified
- Details on embryotoxic / teratogenic effects:
- N/A
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 300 mg/kg bw/day
- Basis for effect level:
- other: embryotoxicity & teratogenicity
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 150 mg/kg bw/day
- Basis for effect level:
- other: embryotoxicity & teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- yes
- Lowest effective dose / conc.:
- 300 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Any other information on results incl. tables
Table 6.8.1-01a Summary of reproductive outcomes
Dose |
0 |
75 |
150 |
300 |
600 |
Corpora lutea |
16.3 |
16.3 |
15.8 |
17.4 |
17.0 |
Implantations |
15.4 |
15.0 |
14.7 |
15.3 |
15.9 |
Total number of resorptions |
0.7 |
0.8 |
0.7 |
0.6 |
0.6 |
Total number of foetuses |
14.6 |
14.2 |
14.0 |
14.7 |
15.3 |
Total number of live foetuses |
14.6 |
14.2 |
14.0 |
14.7 |
15.3 |
Mean foetal weight |
5.02 |
5.20 |
5.17 |
5.05 |
4.38 |
Sex ratio |
0.44 |
0.49 |
0.50 |
0.50 |
0.48 |
Table 6.8.1-01b Summary of skeletal anomalies
Dose |
0 |
75 |
150 |
300 |
600 |
Skeletal examination |
366 (25) |
354 (25) |
321 (23) |
339 (23) |
351 (23) |
Fused rib (No. of litters) |
0 (0) |
0 (0) |
0 (0) |
2 (2) |
9 (9) |
Absent ribs (No. of litters) |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
3 (3) |
Fused vertebra (No. of litters) |
0 (0) |
0 (0) |
0 (0) |
2 (2) |
6 (6) |
Hemi-vertebra (No. of litters) |
0 (0) |
1 (1) |
0 (0) |
1 (1) |
8 (8) |
Abnormally fused sternebra |
0 (0) |
0 (0) |
0 (0) |
0 (0) |
3 (3) |
Cleft/non-fused sternebra |
1 (1) |
0 (0) |
0 (0) |
1 (1) |
6 (5) |
Misaligned sternebra |
1 (1) |
1 (1) |
0 (0) |
1 (1) |
13 (9) |
Incompletely ossified sternebra |
14 (6) |
4 (2) |
13 (2) |
12 (3) |
60 (14) |
Incompletely ossified vertebra |
95 (19) |
119 (21) |
68 (17) |
114 (22) |
204 (21) |
Applicant's summary and conclusion
- Conclusions:
- There was no evidence of either maternal or developmental toxicity at either 150 or 75 mg/kg bw/day. Thus, the maternal and developmental no-observed-effect level (NOEL) was 150 mg/kg bw/day. Therefore, the results indicate that glycolic acid is not likely to be uniquely toxic to the rat conceptus, developmental effects were only apparent at maternally toxic doses.
- Executive summary:
Glycolic acid was administered by gavage to groups of 25 Crl:CD BR female rats on days 7-21 of gestation at daily dose levels of 0, 75, 150, 300, or 600 mg/kg.
Compound-related, adverse maternal and developmental toxicity was observed at 600 mg/kg. Maternal effects included significant reductions in maternal weight changes, body weights, and food consumption. Adverse clinical observations were significantly increased at this level as well as included abnormal gait/staggering, lung noise (wheezing and/or rattling), irregular respiration, and lethargy. There were no remarkable post-mortem findings in the dams. Developmental toxicity was evident at this level as well as significantly reduced mean fetal weight and a significant increase in the incidence of fetal malformations and variations.
Marginal evidence was detected at 300 mg/kg bw/day. Regarding maternal toxicity, lung noise similar to that observed at 600 mg/kg bw/day was observed in 2 of 25 dams (p=0.0553). Developmental toxicity was evident only as a slight but not statistically significant (p=0.0555) increase in the incidence of skeletal malformations. No other maternal or developmental parameters were affected.
There was no evidence of either maternal or developmental toxicity at either 150 or 75 mg/kg bw/day. Thus, the maternal and developmental no-observed-effect level (NOEL) was 150 mg/kg bw/day. Therefore, the results indicate that glycolic acid is not likely to be uniquely toxic to the rat conceptus, developmental effects were only apparent at maternally toxic doses.
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