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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 227-842-3 | CAS number: 6000-44-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No study required since no adverse effects on reproductive organs were observed in a repeat dose toxicity study, and no effects were observed in developmental toxicity studies with glycine.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Glycine (CAS 56-40-6) showed no effects on embryo-fetal growth and development in 3 species
NOAEL developmental toxicity:
Mouse at least 720 mg/kg bw/day; rat at least 855 mg/kg bw/day; hamster at least 560 mg/kg bw/day.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- See read across document in section 13
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- FDA 71-42 (Glycine (Amino acetic acid))
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- Adult female CD-1 mice were individually housed in plastic cages with free access to food and water in a temperature and humidity control facility.
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Virgin females were mated with males and observation of a vaginal plug was considered gestation day 0.
- Duration of treatment / exposure:
- Gestation days 6 through 15
- Frequency of treatment:
- Daily
- Duration of test:
- Up to gestation day 17
- Dose / conc.:
- 7 mg/kg bw/day
- Dose / conc.:
- 33 mg/kg bw/day
- Dose / conc.:
- 155 mg/kg bw/day
- Dose / conc.:
- 720 mg/kg bw/day
- No. of animals per sex per dose:
- 21-26
- Control animals:
- yes, sham-exposed
- other: Aspirin
- Details on study design:
- Female CD-1 mice were administered the test material, positive control, or sham from gestation day 6 through 15. Body weights were recorded on gestation days 0, 6, 11, 15, and 17. All mice were observed daily for clinical signs and food consumption.
- Maternal examinations:
- Not specified
- Ovaries and uterine content:
- On GD 17, females were sacrificed, caesarean sections were performed and the numbers of implantation sites, resorption sites, and live and dead fetuses.
- Fetal examinations:
- All fetuses were examined for external abnormalities. One-third of fetuses from each litter were examined for visceral abnormalities. The remaining two-thirds of fetuses were examined for skeletal abnormalities.
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- One female in the 7.0 mg/kg bw/day group died or aborted prior to gestation day 17.
- 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
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 720 mg/kg bw/day
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 720 mg/kg bw/day
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- Glycine (Amino acetic acid) at dose levels up to 720 mg/kg bw/day had no effect on pregnany or embryo/fetal development.
- Executive summary:
Developmental toxicity was investigated in groups of pregnant female mice exposed from gestation day 6 through 15 to glycine (amino acetic acid) at dose levels of 7, 33, 155, and 720 mg/kg bw/day with a concurrent sham group and a positive control group (aspirin). Dams were euthanized on gestation day 17 and the following observaitons were made: number of resorptions, number of live and dead fetuses. Fetuses were examined for external, visceral, and skeletal abnormalities, and sex was determined and body weight measured.
No deaths were noted in the dams. No treatment-related effects were seen in the number of implantation sites, resorbed or dead fetuses, number of live fetuses, sex distribution, or fetal external, visceral, and skeletal development.
The NOAEL for teratogenicity was 720 mg/kg bw/day.
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- See read across document in section 13
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- FDA 71-42 (Glycine (Amino acetic acid))
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- Adult female albino rats were individually housed in mesh bottom cages in a temperature and humidity-controled facility. Animals had free access to water and food.
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Adult virgin females were mated with males and observations of a vaginal plug was considered gestation day 0.
- Duration of treatment / exposure:
- Gestation day 0 through 15
- Frequency of treatment:
- Daily
- Duration of test:
- Up to gestation day 20
- Dose / conc.:
- 9 mg/kg bw/day
- Dose / conc.:
- 40 mg/kg bw/day
- Dose / conc.:
- 185 mg/kg bw/day
- Dose / conc.:
- 855 mg/kg bw/day
- No. of animals per sex per dose:
- 24
- Control animals:
- yes, sham-exposed
- other: Positive control
- Details on study design:
- Female rats were administered the test material, positive control, or sham from gestation day 6 through 15. Body weights were recorded on gestation days 0, 6, 11, 15, and 20. All rats were observed daily for clinical signs and food consumption.
- Ovaries and uterine content:
- On GD 20, females were sacrificed, caesarean sections were performed and the numbers of implantation sites, resorption sites, and live and dead fetuses.
- Fetal examinations:
- All fetuses were examined for external abnormalities. One-third of fetuses from each litter were examined for visceral abnormalities. The remaining two-thirds of fetuses were examined for skeletal abnormalities.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One female in the 855 mg/kg bw/day group died prior to gestation day 20.
- Body weight and weight changes:
- no effects observed
- Number of abortions:
- no effects observed
- 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
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 855 mg/kg bw/day
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 855 mg/kg bw/day
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- Glycine (Amino acetic acid) at dose levels up to 855 mg/kg bw/day had no effect on pregnany or embryo/fetal development.
- Executive summary:
Developmental toxicity was investigated in groups of pregnant female rats exposed from gestation day 6 through 15 to glycine (amino acetic acid) at dose levels of 9, 40, 185, and 855 mg/kg bw/day with a concurrent sham group and a positive control group (aspirin). Dams were euthanized on gestation day 20 and the following observaitons were made: number of resorptions, number of live and dead fetuses. Fetuses were examined for external, visceral, and skeletal abnormalities, and sex was determined and body weight measured. No deaths were noted in the dams. No treatmentrelated effects were seen in the number of implantation sites, resorbed or dead fetuses, number of live fetuses, sex distribution, or fetal external, visceral, or skeletal development.
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Justification for type of information:
- See read across document in section 13
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- FDA 71-42 (Glycine (Amino acetic acid))
- Species:
- hamster, Syrian
- Details on test animals or test system and environmental conditions:
- Adult female hamsters were individually housed in mesh bottom cages in a temperature and humidity-controled facility. Animals had free access to water and food.
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Virgin female hamsters were mated 1:1 with mature males and the appearance of sperm in the vaginal smear was considered gestation day 0.
- Duration of treatment / exposure:
- Gestation days 6 through 10
- Frequency of treatment:
- Daily
- Duration of test:
- Gestation days 6 through 14
- Dose / conc.:
- 6 mg/kg bw/day
- Dose / conc.:
- 26 mg/kg bw/day
- Dose / conc.:
- 120 mg/kg bw/day
- Dose / conc.:
- 560 mg/kg bw/day
- No. of animals per sex per dose:
- 20-22
- Control animals:
- yes, sham-exposed
- other: Positive control
- Details on study design:
- Female hamsters were administered the test material, positive control, or sham from gestation day 6 through 10. Body weights were recorded on gestation days 0, 8, 10, and 14. All hamsters were observed daily for clinical signs and food consumption.
- Ovaries and uterine content:
- On GD 14, females were sacrificed, caesarean sections were performed and the numbers of implantation sites, resorption sites, and live and dead fetuses
- Fetal examinations:
- All fetuses were examined for external abnormalities. One-third of fetuses from each litter were examined for visceral abnormalities. The remaining two-thirds of fetuses were examined for skeletal abnormalities.
- Mortality:
- mortality observed, non-treatment-related
- Body weight and weight changes:
- no effects observed
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- Three females in the sham group and one female in the 26 mg/kg bw/day group aborted or died prior to gestation day 14.
- 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
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 560 mg/kg bw/day
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 560 mg/kg bw/day
- Basis for effect level:
- other:
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Developmental effects observed:
- no
- Conclusions:
- Glycine (Amino acetic acid) at dose levels up to 560 mg/kg bw/day had no effect on pregnany or embryo/fetal development
- Executive summary:
Developmental toxicity was investigated in groups of pregnant female hamsters exposed from gestation day 6 through 10 to glycine (amino acetic acid) at dose levels of 6, 26, 120, and 560 mg/kg bw/day with a concurrent sham group and a positive control group (aspirin). Females were euthanized on gestation day 14 and the following observaitons were made: number of resorptions, number of live and dead fetuses. Fetuses were examined for external, visceral, and skeletal abnormalities, and sex was determined and body weight measured. No deaths were noted in the dams. No treatmentrelated effects were seen in the number of implantation sites, resorbed or dead fetuses, number of live fetuses, sex distribution, or fetal external, visceral, or skeletal development.
Referenceopen allclose all
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 855 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Studies evaluating effects on reproduction have not been performed; however, based on repeat dose toxicity studies and developmental toxicity studies of glycine there are no expected effects on reproduction.
Groups of 6 male rats were administered 500, 1000, or 2000 mg/kg bw/day glycine in water by oral gavage for 28 days. There were no effects on the measured parameters, and there were no deaths up to 2000 mg/kg bw/day. There were no effects on the measured parameters, and there were no deaths up to 2000 mg/kg bw/day.
Groups of 50 male and 50 female F344 DuCrj rats (aged 6 weeks) were given drinking-water containing 0, 2.5 or 5% glycine (equivalent to approximately 0, 2500 or 5000mg/kgbw per day) for 108 weeks. A complete histopathological evaluation performed at necropsy with no effects noted on any reproductive organs.
Developmental toxicity was investigated in mice, rats, and hamsters. No treatment-related effects were seen in the number of implantation sites, resorbed or dead fetuses, number of live fetuses, sex distribution, or fetal external, visceral, or skeletal development.
Based on the results of these studies effects on reproduction are not expected.
Additional information
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.