Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Unpublished data cited in a peer-reviewed publication

Data source

Reference
Reference Type:
secondary source
Title:
Diaethylcarbonat - Untersuchungen auf embryotoxische und teratogene Wirkungen an der Ratte (unpublished report)
Author:
Bayer AG
Year:
1969
Bibliographic source:
BG Chemie (1994) Toxicological Evaluations 7. Potential Health Hazards of Existing Chemicals. Springer Verlag

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
see below
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
no data

Test animals

Species:
rat
Strain:
other: FB30
Details on test animals and environmental conditions:
Age at study initiation: 10-14 weeks
Weight at study initiation: 200-250 g

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Analytical verification of doses or concentrations:
no
Details on mating procedure:
not further specified
Duration of treatment / exposure:
days 6-15 of gestation
Frequency of treatment:
continuously via drinking water
Duration of test:
not further specified
Doses / concentrations
Remarks:
Doses / Concentrations:
0.01, 0.1 and 1 % in drinking water (ca. 34, 351 and 3204 mg/rat/day)
Basis:

No. of animals per sex per dose:
10 f
Control animals:
yes

Examinations

Maternal examinations:
CAGE SIDE OBSERVATIONS: Yes
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: No data
WATER CONSUMPTION AND COMPOUND INTAKE: Yes
POST-MORTEM EXAMINATIONS: Yes
Ovaries and uterine content:
not further specified
Fetal examinations:
not further specified
Statistics:
no data
Indices:
not further specified

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Maternal toxic effects:no effects

Effect levels (maternal animals)

Dose descriptor:
NOAEL
Effect level:
3 204 other: mg/rat/day
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:no effects

Effect levels (fetuses)

open allclose all
Dose descriptor:
NOAEL
Effect level:
3 204 other: mg/rat/day
Basis for effect level:
other: teratogenicity
Dose descriptor:
NOAEL
Effect level:
3 204 other: mg/rat/day
Basis for effect level:
other: embryotoxicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
In this study with female FB30 rats, the dosing with up to 3204 mg/rat/day via drinking water from day 6-15 of gestation caused no maternal toxicity or embryotoxic and teratogenic effects.
Executive summary:

In this study with female FB30 rats, the dosing with up to 3204 mg/rat/day via drinking water from day 6-15 of gestation caused no maternal toxicity or embryotoxic and teratogenic effects.