Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

The reproductive/developmental toxicity screening study is waived in accordance with Annex VIII, 8.7.1 column 2 of the REACH regulation. A testing proposal has been submitted to ECHA for the conduct of a developmental toxicity study on a structurally related substance (methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate; CAS 10595-49-0).

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reproductive effects observed:
not specified
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

A testing proposal has been submitted to ECHA for an oral developmental toxicity study in rats on a structurally related substance (methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate;

CAS 10595-49-0). The results of this study will be read-across to this substance.
Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes
Species:
rat
Route of administration:
oral: gavage
Abnormalities:
not specified
Developmental effects observed:
not specified
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Quality of whole database:
There is a testing proposal for an oral developmental toxicity study in rats on a structurally related substance.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

There is currently no evidence available to indicate that the substance is toxic to reproduction and therefore classification is not justified. A developmental study in the rat by the oral dose route is planned on a structural analogue. When the results are available they will be evaluated and the classification reviewed.