Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned (based on read-across)
Study period:
Study planned to start within 6 months of final confirmation from ECHA
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
- It should be noted that no new animal testing has been proposed for this substance. A new study on an analogue substance has been proposed and will be used for read-across to this substance when available.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 3-Lauramidopropyl trimethyl ammonium methyl sulfate (CAS No. 10595-49-0)
- Name of the substance for which the testing proposal will be used: trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION]:
- Available GLP studies: None available
- Available non-GLP studies: None available
- Historical human data: None available
- (Q)SAR: Not sufficiently robust for developmental toxicity, in particular compared to the option of read-across from an analogue substance.
- In vitro methods: Not sufficiently robust for developmental toxicity, in particular compared to the option of read-across from an analogue substance.
- Weight of evidence: No developmental toxicity studies available
- Grouping and read-across: A pre-natal developmental toxicity study has already been proposed on an analogue substance (methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate; CAS 10595-49-0) which has already been used as a source substance for read-across. Therefore in order to make maximum use of the proposed study, it will also be used for read-across to this substance.
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
- Other reasons: 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:
- It should be noted that no new animal testing has been proposed for this substance. A new study on an analogue substance has been proposed and will be used for read-across to this substance when available.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: OECD 414 study in the rat by the oral dose route

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 material form:
liquid

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