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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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other: Unpublished data cited in a peer-reviewed publication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Diaethylcarbonat - Untersuchungen auf embryotoxische und teratogene Wirkungen an der Ratte (unpublished report)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

Constituent 1
Chemical structure
Reference substance name:
Diethyl carbonate
EC Number:
203-311-1
EC Name:
Diethyl carbonate
Cas Number:
105-58-8
Molecular formula:
C5H10O3
IUPAC Name:
diethyl carbonate
Test material form:
other: liquid
Details on test material:
no data

Test animals

Species:
rat
Strain:
other: FB30
Details on test animals or test system 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.