Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned (based on read-across)
Study period:
Results should be available 18 months after final decision
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
In the Amphoacetates C8-C18 (EC number: 931-291-0) dossier, which has already been submitted to ECHA, a prenatal developmental toxicity study in the rat according to OECD guideline 414, testing by oral route, is proposed. A read-across from this study will be used to cover the endpoint toxicity to reproduction (REACH Regulation, Annex VII, 8.7.1). As soon as study data are available, a robust study summary will be prepared and submitted within an update of the dossier. Evaluation will be reconsidered based on the outcome of the prenatal developmental toxicity study. In conclusion, a prenatal developmental toxicity study will be conducted with the closely related source substance Amphoacetates C8-C18. Hence, a further testing proposal for a prenatal developmental toxicity study with the target substance itself is considered not justified. A justification for read-across is included in this dossier (attached to IUCLID chapter 13).

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Amphoacetates C8-C18

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: no studies available
- Available non-GLP studies: no studies available
- Historical human data: no data available
- (Q)SAR: No adequate QSAR model is available to fulfill this information requirement.
- In vitro methods: Currently no validated and accepted in vitro methods are available to cover this endpoint.
- Weight of evidence: No adequate data are available, neither for the target substance, nor for related substances, to cover this endpoint.
- Grouping and read-across: A read-across approach from Amphoacetates C8-C18 will be used (see above) to cover this endpoint for the target substance Amphopropionates C12-18 to avoid unnecessary animal testing.
- Substance-tailored exposure driven testing [if applicable]: Based on use conditions, exposure cannot be completely excluded.
- Approaches in addition to above [if applicable]: n.a.
- Other reasons [if applicable]: n.a.

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:
No data are available that would justify a classification of the substance as toxic for reproduction category 1A or 1B. The substance is not genotoxic and no known germ cell mutagen.
The substance is of low toxicological activity as demonstrated in the 28 d repeated dose toxicity study. However, exposure and systemic availability cannot completely be excluded. Thus, the adaptation possibilities of annex VIII do not apply.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: OECD TG 414 (rat; oral)
Cross-reference
Reason / purpose:
read-across: supporting information

Data source

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion