Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
to be determined by ECHA
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: Amides, C12-C18 (even numbered), N-[3-(dimethylamino) propyl], Nā€™-oxides

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: A reproduction/developmental toxicity screening test was performed according to OECD guideline 421. A key 90-day repeated dose toxicity study in rats via oral gavage (performed according to OECD guideline 408) is also available.
- Available non-GLP studies: No studies available
- Historical human data: No data available
- (Q)SAR: No (Q)SAR data can be used in a stand alone approach to assess the developmental toxicity potential. According to ECHA guidance document R.7a (Dec 2016), QSAR approaches are currently not fitted-for-purpose for reproductive toxicity and not all necessary aspects can be covered by a QSAR prediction.
- In vitro methods: No in vitro method is available. Some in vitro tests have been developed; however, according to ECHA guidance document R.7a (Dec 2016), these in vitro methods have not yet reached regulatory acceptance and do not provide stand-alone, equivalent information.
- Weight of evidence: No data is available which would allow a weight of evidence approach.
- Grouping and read-across: No chemical grouping or read-across approach was identified
- Substance-tailored exposure driven testing [if applicable]: Not applicable
- Approaches in addition to above [if applicable] : Not applicable
- Other reasons [if applicable]: Not applicable

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:
- This test proposal is fully compliant with the ECHA guidance document R.7a (Dec 2016). It is not possible to waive the study based on column 2 adaptations of the REACH Regulation.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- No additional 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

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