Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
After approval by ECHA
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE: 1,2-Dimethylimidazole

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: study according to OECD TG422 in rats per gavage (2015)
- Available non-GLP studies: no studies adressing the endpoint pre-natal developmental toxicity
- Historical human data: no data available
- (Q)SAR: not applicable for pre-natal developmental toxicity
- In vitro methods: not applicable for pre-natal developmental toxicity
- Weight of evidence: data base not sufficient for a weight of evidence
- Grouping and read-across: no read-across or gouping to other imidazole derivatives as these differ in their toxicity profiles, e.g. developmental toxicity, skin corrosivity or sensitisation, respectively.
- Substance-tailored exposure driven testing: testing for repeated dose toxicity is performed prior to testing for pre-natal developmental toxicity (see chapter 7.5.1)

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
REACH 1272/2006 Annex IX, 8.7.2, column 2: The study shall be initially performed on one species. A decision on the need to perform a study at this tonnage level or the next on a second species should be based on the outcome of the first test and all other relevant available data.
The testing proposal for a pre-natal developmental toxicity study according to OECD TG414 is proposed for the first species (rat). The decision on the need to perform a study on a second species can be made not before this first proposed test was performed and reported.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion