Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
The study will be conducted after a decision on the requirement to carry out the proposed test has been taken according to the procedure laid down in Regulation (EC) 1907/2006, and a deadline to submit the information required has been set by the Agency.
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Reaction mass of 2-(3,4-dimethyl-1H-pyrazol-1-yl)succinic acid and 2-(4,5-dimethyl-1H-pyrazol-1-yl)succinic acid (EC 940-877-5)

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: No adequate and reliable GLP studies addressing developmental toxicity are available with the registered substance itself or similar substances defined according to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006. A 28-day oral Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test is available for the registered substance Reaction mass of 2-(3,4-dimethyl-1H-pyrazol-1-yl)succinic acid and 2-(4,5-dimethyl-1H-pyrazol-1-yl)succinic acid (EC 940-877-5), which was conducted according to OECD guideline 422, and in compliance with GLP.
- Available non-GLP studies: none for developmental toxicity endpoint
- Historical human data: not available
- (Q)SAR: Q(SAR) methods are not applicable to assess the full scope of developmental toxicity.
- In vitro methods: No validated in vitro methods to assess developmental toxicity are available so far.
- Weight of evidence: There is no information (QSAR, in vitro data, developmental toxicity or fertility data) available which is suitable to assess developmental toxicity in a weight of evidence approach.
- Grouping and read-across: No read-across data is available for the developmental toxicity endpoint.

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:
- There is no data available on prenatal developmental toxicity with Reaction mass of 2-(3,4-dimethyl-1H-pyrazol-1-yl)succinic acid and 2-(4,5-dimethyl-1H-pyrazol-1-yl)succinic acid. Validated or regulatory accepted alternative methods are not available for replacing animal testing with respect to prenatal developmental toxicity. Furthermore, no appropriate read-across substances are available and there are no Column 2 adaptations for developmental toxicity. Thus, as there are only screening data regarding developmental toxicity available, a GLP-compliant prenatal developmental toxicity study in rats via oral route following OECD 414 is proposed according to Annex IX, column 1, section 8.7.2.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: a Prenatal Developmental Toxicity study in rodents (OECD 414) by oral route will be conducted with Reaction mass of 2-(3,4-dimethyl-1H-pyrazol-1-yl)succinic acid and 2-(4,5-dimethyl-1H-pyrazol-1-yl)succinic acid (EC 940-877-5).

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

Applicant's summary and conclusion