Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned (based on read-across)
Study period:
The study will be conducted after a final decision on the requirement to carry out the proposed test has been taken 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, CAS 2241455-89-8)
- Name of the substance for which the testing proposal will be used: Reaction mass of dipotassium 2-(3,4-dimethyl-1H-pyrazol-1-yl) succinate and dipotassium 2-(4,5-dimethyl-1H-pyrazol-1-yl)succinate (EC 950-225-1)

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, CAS 2241455-89-8), 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 are no Column 2 adaptations for developmental toxicity.

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 the source 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, CAS 2241455-89-8). A Draft Decision on a testing proposal (DEV-01-2120055695-48-000-TPE-1_DEC_REG_TPE) is submitted for the read across 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, CAS 2241455-89-8). As soon as the data is available, this information can be used to fulfil the standard information requirements according to Annex X, Column I, 8.7.2. Please refer to analogue justification provided in IUCLID section 13.

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