Reaction products of [3-(2,3-epoxypropoxy)propyl]trimethoxysilane and triacetoxyvinylsilane.

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian cell study: DNA damage and/or repair

Type of information:

experimental study planned

Study period:

After approval 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: Reaction mass of 3-(2,3-epoxypropoxy)propyltrimethoxysilane and triacetoxyvinylsilane, CAS 154518-41-9

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 in vivo gentox studies are available.
- Available non-GLP studies: No in vivo gentox studies are available.
- Historical human data: No relevant data are available
- (Q)SAR: No(Q)SAR method is available which can follow up on positive results from in vitro studies
- In vitro methods: The in vitro data available indicate potential for mutagenicity and clastogenicity, and the substance has an epoxy group which is a structural alert for mutagenicity. However, it is not usual to base a conclusion for classification solely on in vitro data, so in accordance with REACH ANNEX VIII Section 8.4 a combined micronucleus/comet in vivo study is proposed.
- Gene mutation (Bacterial reverse mutation assay / Ames test): positive with and without activation in Salmonella typhimurium strains TA 100, TA 1535 and E. coli WP2 uvr A, but not in TA 98 or TA 1537 (OECD TG 471) (Harlan, 2010).
- Gene mutation (Mammalian cell gene mutation assay): positive with and without activation in mouse lymphoma L5178Y cells (OECD TG 476) (Dow Corning Corporation, 1999).
- Cytogenicity in mammalian cells: positive in peripheral human lymphocytes (according to OECD TG 473) (WIL, 2015).
- Weight of evidence: no suitable weight of evidence data are available
- Grouping and read-across: no relevant in vivo data are available for the surrogate 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:
- There are no specific adaptation possibilities to generate the necessary information

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: Combined micronucleus/comet assay in rats.
- Route of exposure: oral
- Tissues to be sampled for comet assay: glandular stomach (primary site of contact following exposure via the oral route), liver (primary site of xenobiotic metabolism) and bone marrow (may serve as bioavailability check if mutagenicity is positive but micronucleus part is negative).

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

other: Liquid

Test animals

Species:

rat

Administration / exposure

Route of administration:

oral: gavage