Registration Dossier
Registration Dossier
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EC number: 240-464-3 | CAS number: 16415-12-6
Toxicity to reproduction
Administrative data
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Type of information:
- experimental study planned
- 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
NON-CONFIDENTIAL NAME OF SUBSTANCE: hexadecyltrimethoxysilane (CAS 16415-12-6)
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 for the reproductive toxicity endpoint
- Available non-GLP studies - none for the reproductive toxicity endpoint.
- Historical human data - no data.
- (Q)SAR - no data.
- In vitro methods - no validated alternative in vitro methods are available.
- Weight of evidence - 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 – No suitable read-across options are available.
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:
- This test cannot be waived based on carcinogenicity, germ cell mutation, toxicokinetics or exposure data, or classification for reproduction or development.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION: an Extended One-Generation Reproductive Toxicity Study is proposed.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 443 (Extended One-Generation Reproductive Toxicity Study)
- GLP compliance:
- yes
- Justification for study design:
- according to OECD guideline 443
Test material
- Reference substance name:
- Hexadecyltrimethoxysilane
- EC Number:
- 240-464-3
- EC Name:
- Hexadecyltrimethoxysilane
- Cas Number:
- 16415-12-6
- Molecular formula:
- C19H42O3Si
- IUPAC Name:
- hexadecyltrimethoxysilane
Constituent 1
Test animals
- Species:
- rat
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
