Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- S.typhimurium strain TA97a was used as a substitute for the strains TA97 and/or TA1537 normally recommended by EEC and Japan guidelines. THe substitution is acceptable for this design and has no impact on the study validity. The positive control for thi
- Qualifier:
- according to guideline
- Guideline:
- other: EPA-OPPTS 40 CFR 799.9510
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
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 70% solution
Constituent 1
Method
- Target gene:
- S. typhimurium TA97a- hisD6610, hisO1242.
S. typhimurium TA98- hisD3052.
S. typhimurium TA100- hisG46.
S. typhimurium TA1535- hisG46.
E. coli WP2 uvrA (pKM101)- trpE.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97a
- Additional strain / cell type characteristics:
- other: Histidine mutations: his D6610, his O1242; Additional mutations: rfa uvrB
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: Histidine mutations: his D3052; Additional mutations: rfa uvrB
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: Histidine mutations: his G46; Additional mutations: rfa uvrB
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: Histidine mutations: his G46; Additional mutations: rfa uvrB R-factor (pKM101 plasmid)
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Additional strain / cell type characteristics:
- other: Histidine mutations: trpE; Additional mutations: rfa uvrA R-factor (pKM101 plasmid)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Trial 1
S. typhimurium TA100 and E. coli WP2 uvrA (pKM101)- 1, 5, 10, 50, 100, 500, 1000, 2500, 5000 ug/plate.
S. typhimurium TA97a, TA98 and TA1535- 10, 50, 100, 500, 1000, 2500, 5000 ug/plate.
Trial 2 All strains 10, 50, 100, 500, 1000, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Test substance solvent/dilutent/negative control: Phosphate buffered saline (PBS.)
- Deionized water was the solvent for NAAZ and ICR 191
- The solvent for 2AA, 2NF, DMBA, and ENNG was dimethyl sulfoxide (DMSO)
- Justification for choice of solvent/vehicle: Based on a solubility test that allowed for the preparation of a soluble or
workable stock concentration up to 50 mg/ml.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9,10-dimethylbenzanthracene
- Remarks:
- applies for S. typhimurium TA 97a + S9 mix
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: ICR 192 acridine mutagen (ICR 191)
- Remarks:
- applies for S. typhimurium TA 97a - S9 mix
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2AA)
- Remarks:
- applies for S. typhimurium TA 98 + S9 mix
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- applies for S. typhimurium TA 98 - S9 mix
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2AA)
- Remarks:
- applies for S. typhimurium TA 100 + S9 mix
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- applies for S. typhimurium TA 100 - S9 mix
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2AA)
- Remarks:
- applies for S. typhimurium TA 1535 + S9 mix
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- applies for S. typhimurium TA 1535 - S9 mix
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2AA)
- Remarks:
- applies for E. coli WP2 uvr A pKM 101 + S9 mix
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- applies for E. coli WP2 uvr A pKM 101 - S9 mix
- Details on test system and experimental conditions:
- After pouring top agar onto minimal glucose agar plates and allowing to solidify, the plates were incubated for 48 hours at 37°C.
METHOD OF APPLICATION: In agar (plate incorporation method.)
DURATION
- Preincubation period: over night
- Exposure duration: 48hr
- Selection time (if incubation with a selection agent): 48 hr
SELECTION AGENT (mutation assays): histidine for S. typhimurium, and tryptophan for E. coli
NUMBER OF CELLS EVALUATED: 1x10^8 cells/plate
DETERMINATION OF CYTOTOXICITY
- Evidence of toxicity was scored relative to the concurrent negative control plates. A minimum of three on-toxic
concentration levels was required to classify the test substance. A concentration level was considered non-toxic if it
caused less than 50% reduction in the mean number of revertants per plate relative to the mean of the concurrent negative
control. - Evaluation criteria:
- Bacterial lawns were evaluated for evidence of toxicity or test substance precipitation and scored by comparison with concurrent negative control plates. Revertant colonies were counted uing an automatic colony counter for each tester strain unless prohibited by excessive toxicity. Manual counting was employed, as appropriate, if test substance precipitation interfered with automatic counting.
- Positive (or mutagenic) if the mean number of revertants in any strain at any test substance concentration was at least 2
times greater than the mean of the concurrent vehicle control and there was a concentration related increase in the mean
revertants per plate in that same strain.
- Negative (or not mutagenic) if there was no test substance concentration with a mean number of revertants that was at
least 2 times greater than the mean of concurrent vehicle control. Or, if there was no positive concentration related
increase in the mean revertants per plate in that same strain.
- Equivocal if the results not meeting positive or negative criteria classification were evaluated using scientific judgement
and experience and possibly reported as equivocal. - Statistics:
- For each strain, the mean number of revertants and the standard deviation were calculated at each concentration, with or without metabolic activation
Data for each tester strain were evaluated independently. For each tester strain, the mean number of revertants and the
standard deviation at each concentration in the presence of and absence of the exogenous metabolic activation system
were calculated.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: yes, ≥ 1000 µg/plate (generally)
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: yes, ≥ 1000 µg/plate (generally)
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: yes, ≥ 1000 µg/plate (generally)
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: yes, ≥ 1000 µg/plate (generally)
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in bacterial background lawns at 500ug/plate or higher in trial 1 without activation and 1000ug/plate or higher in trial 2 without activation, and 2500ug/plate or higher with activation in both trial 1 and 2
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Under the conditions of this study, no evidence of mutagenic activity was detected in either of two independent trials. Based on these data, the test substance was judged to be negative for mutagenic activity.
Any other information on results incl. tables
Under the conditions of this study, no evidence of mutagenic activity was detected in either of two independent trials. Based on these data, the test substance was judged to be negative for mutagenic activity.
Applicant's summary and conclusion
- Conclusions:
- Glycolic acid showed no mutagenic effect in any of the bacterial tester strains with and without metabolic activation. Under the conditions of this study, no evidence of mutagenic activity was detected in either of two independent trials. Based on these data, the test substance was judged to be negative for mutagenic activity.
- Executive summary:
Glycolic acid showed no mutagenic effect in any of the bacterial tester strains with and without metabolic activation.
Under the conditions of this study, no evidence of mutagenic activity was detected in either of two independent trials. Based on these data, the test substance was judged to be negative for mutagenic activity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.