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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Referenceopen allclose all

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.

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