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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
other information
Study period:
July 1992
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 MT et al.
Year:
1992
Bibliographic source:
Res Commun Chem Pathol Pharmacol 77(1):95-106.

Materials and methods

GLP compliance:
not specified

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) on 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.
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/ day of lactic acid.
Executive summary:

There was no test item-specific developmental toxicity observed in mice exposed orally to 570 mg/kg/day of lactic acid. 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.