Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate

Endpoint summary

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

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.