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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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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:
1972

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

Constituent 1
Reference substance name:
Glycine
EC Number:
200-272-2
EC Name:
Glycine
Cas Number:
56-40-6
Molecular formula:
C2H5NO2
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.