Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

No data in order to evaluate reproductive toxicity of the registered substance are available.

According to Regulation (EC) No 1907/2006, Annex VIII, 8.7.1., column 2, a screening test for toxicity to reproduction has to be performed in one species via the most appropriate route of administration, having regard to the likely route of human exposure. A pre-natal developmental toxicity study via the oral route according to OECD Guideline 414 for the structurally related read-across substance Hexadecyltrimethoxysilane (CAS 16415-12-6) is proposed and the generated data will comply with the criteria for read-across according to Annex XI, article 1.5. The results of the study will be used to determine the following steps in the testing regime.

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
other justification
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

No data in order to evaluate developmental toxicity are available. A testing proposal for a developmental toxicity study according to OECD TG 414 is submitted for the structural analogue substance hexadecyl(trimethoxy)silane (16415-12-6). As soon these data is available they will be included in the dossier.

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
experimental study planned (based on read-across)
Study period:
The test will be conducted after a decision on the requirement to carry out the proposed test has been taken according to the procedure laid down in Regulation (EC) 1907/2006 and a deadline to submit the information required has been set by the Agency.
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
OECD Guideline 414 (Prenatal Developmental Toxicity Study) in rats with a read-across substance. The testing proposal for the read-across substance is already submitted.

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: hexadecyl(trimethoxy)silane / CAS 16415-12-6 / EC 240-464-3
- Name of the substance for which the testing proposal will be used: triethoxyhexadecylsilane / CAS 16415-13-7 / EC 240-465-9

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: No adequate and reliable GLP studies addressing developmental toxicity or reproductive toxicity in general are available with the test substance itself or similar substances defined according to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006.
- Available non-GLP studies: No adequate and reliable non-GLP studies addressing developmental toxicity or reproductive toxicity in general are available with the test substance or similar substances.
- Historical human data: not available
- (Q)SAR: Currently available Q(SAR) methods are not applicable to assess the full scope of developmental toxicity
- In vitro methods: No validated in vitro methods to assess developmental toxicity are available so far.
- Weight of evidence: So far there is no information (QSAR, in vitro data, repeated dose or fertility data) available which is suitable to assess developmental toxicity in a weight of evidence approach.
- Grouping and read-across: The proposed test is part of a sequential testing strategy program for alkoxysilanes which is developed in close collaboration with ECHA to minimise the need for additional animal testing.

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:
In order to fulfil the standard information requirements, a GLP-compliant pre-natal developmental toxicity study in rats via the oral route following OECD guideline 414 is proposed according to Annex IX, Column 1, Section 8.7.2.
Column 2 adaption possibilities at the Annex IX level where considered and do not apply: Based on the available data the test substance is not regarded as CMR substance. In particular it is not known to be a genotoxic carcinogen or germ cell mutagen. In addition it is not classified for reproductive toxicity Cat 1 or 2 in accordance with Regulation (EC) No. 1272/2008. In addition, there are no toxicokinetic studies available which could justify the absence of systemic absorption.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION: none
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
no
GLP compliance:
yes
Species:
rat
Route of administration:
oral: gavage
Developmental effects observed:
not specified
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
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

No data available in order to justify for classification or non-classification.

Additional information