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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
Developmental toxicity / teratogenicity
Administrative data
- 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
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Glycine
- EC Number:
- 200-272-2
- EC Name:
- Glycine
- Cas Number:
- 56-40-6
- Molecular formula:
- C2H5NO2
Constituent 1
- Specific details on test material used for the study:
- FDA 71-42 (Glycine (Amino acetic acid))
Test animals
- 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.
Administration / exposure
- 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
Doses / concentrationsopen allclose all
- 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.
Examinations
- 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.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- 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
Effect levels (maternal animals)
- 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
Results (fetuses)
- 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
Effect levels (fetuses)
- 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 abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- 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.
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