Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
other information

Data source

Reference
Reference Type:
secondary source
Title:
No information
Bibliographic source:
ECHA database; http://apps.echa.europa.eu/registered/data/dossiers/DISS-9d91195a-65f3-618d-e044-00144f67d249/DISS-9d91195a-65f3-618d-e044-00144f67d249_DISS-9d91195a-65f3-618d-e044-00144f67d249.html

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
no

Test animals

Species:
rat

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure (if applicable):
whole body
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 400, 1000, 3000 ppm
Basis:
nominal conc.

Results and discussion

Results: maternal animals

Maternal developmental toxicity

Details on maternal toxic effects:
Details on maternal toxic effects:
Maternal body weights were significantly decreased on day 16 and a decrease in maternal body weight gain occured on days 10 through 15 in rats exposed to 3000 ppm.
Water consumption of rats exposed to 3000 ppm was significantly increased on days 15 through 17 of gestation.

Effect levels (maternal animals)

open allclose all
Dose descriptor:
NOAEC
Effect level:
ca. 1 002 ppm (analytical)
Basis for effect level:
other: developmental toxicity
Dose descriptor:
NOAEC
Effect level:
ca. 1 002 ppm (analytical)
Basis for effect level:
other: maternal toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Details on embryotoxic / teratogenic effects:
Significant decrease in delayed ossification of interparietal bones and significant increase in the incidence of extra lumbar ribs at 3000 ppm.

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion