Registration Dossier
Registration Dossier
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EC number: 200-018-0 | CAS number: 50-21-5
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- abstract
Data source
Reference
- Reference Type:
- publication
- Title:
- Concurrent ingestion of lactate and aluminum can result in developmental toxicity in mice.
- Author:
- Colomina M.T. et al.
- Year:
- 1 992
- Bibliographic source:
- Res. Commun. Chem. Pathol. Pharmacol. 77(1), 95-106
Materials and methods
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Lactic acid
- EC Number:
- 200-018-0
- EC Name:
- Lactic acid
- Cas Number:
- 50-21-5
- Molecular formula:
- C3H6O3
- IUPAC Name:
- 2-hydroxypropanoic acid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- Pregnant Swiss mice were given by gavage daily doses of lactic acid (570 mg/kg bw)during gestational days 6-15.
- Duration of treatment / exposure:
- Gestational days 6-15
- Duration of test:
- Caesarean sections were performed on gestation day 18, and live fetuses were sexed, weighed and examined for morphological defects.
Doses / concentrations
- Dose / conc.:
- 570 mg/kg bw/day (nominal)
- Details on study design:
- The influence of lactate on the potential developmental toxicity of high doses of aluminum was evaluated in this study, and lactic acid was used as a control.
Examinations
- Maternal examinations:
- The reproductive data did not show embryotoxic effects in any group.
- Fetal examinations:
- There was a slight albeit not statistically significant decrease in foetal weight and a statistically significant delayed ossification of parietal bones.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Details on results:
- No maternal toxicity was observed in the group treated with lactic acid alone.
Applicant's summary and conclusion
- Conclusions:
- There was no developmental toxicity observed in mice exposed orally to 570 mg/kg bw/day of lactic acid during gestation days 6-15.
- Executive summary:
There was no test item-specific developmental toxicity observed in mice exposed orally to 570 mg/kg/day of lactic acid during gestation days 6 -15. There was a slight albeit not statistically significant decrease in foetal weight and a statistically significant delayed ossification of parietal bones. However, as the delayed ossification might be due to the decreased foetal weight this finding was not considered to be test item-specific.
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