Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

The reproductive/developmental toxicity screening endpoint is waived in accordance with Annex VIII, 8.7.1 column 2 of the REACH regulation. The registant has submitted a testing proposal for a pre-natal developmental toxicity study. The Extended One Generation Reproductive Toxicity study is waived on the basis that the available repeated dose toxicity studies do not indicate adverse effects on reproductive organs or tissues or reveal other concerns in relation with reproductive toxicity.

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

The registrant has submitted a testing proposal for a pre-natal developmental toxicity study by the oral dose route in rats.

Link to relevant study records

Reference

Endpoint:

developmental toxicity

Type of information:

experimental study planned

Study period:

Study planned to start within 6 months of final confirmation from 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 : 3-Lauramidopropyl trimethyl ammonium methyl sulfate
- Name of the substance for which the testing proposal will be used: 3-Lauramidopropyl trimethyl ammonium methyl sulfate

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 vitro methods : Not sufficiently robust for developmental toxicity
- Weight of evidence : No developmental toxicity studies available
- Grouping and read-across : It has not been possible to identify suitable studies on suitable source substances
- 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:
- No suitable adaption possibllities 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

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.

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 no evidence available to indicate that the substance is toxic to reproduction and it is therefore not classified. As additional studies are conducted the results will be evaluated and the classification reviewed.