Oxirane, mono[(C10-16-alkyloxy)methyl] derivs.

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Two Ames tests performed similar to OECD guideline 471 and under GLP are available. The first study revealed point mutations by base-pair changes in strain 1535 with S9. In the second test negative results were obtained.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Cited from ECHA disseminated dossier Query date: 2015-07-22 For justification of read across please refer to IUCLID section 13.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

E. coli WP2 uvrA, or E. coli WP2 uvrA (pKM101), or S. typhimurium TA102 was not tested.

GLP compliance:

no

Remarks:

pre-GLP

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S9 form male Wistar rats

Test concentrations with justification for top dose:

First experimental: 0, 0.005, 0.024, 0.12, 0.6 and 3 μl/ plate
Second experimental: 0, 0.024, 0.12, 3, 10 μl/ plate

Untreated negative controls:

yes

True negative controls:

no

Positive controls:

yes

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

The results obtained with test material and TA 1535, although indicative for slight mutagenic activity, are considered to be inconclusive, since toxicity of the test chemical for the bacteria interfered with the mutagenicity testing.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Genetic toxicity in vitro

A study of Ames test under GLP was well conducted and recorded according to previous OECD Guideline 471. Five strains, TA 1535, TA 1537, TA1538, TA98 and TA100 were tested to detect GC base pairs mutation. However, AT base pairs mutations or cross-linking mutations can not be excluded because of E.coli WP2 strains or S. typhimurium TA102 was not used according to latest version of OECD Guideline 471. The test material induced point mutations by base-pair changes in strain 1535 with S9.

A pre-GLP study of Ames test was well conducted and recorded which was similar to OECD Guideline 471 and negative results were observed. Five strains, TA 1535, TA 1537, TA1538, TA98 and TA100 were tested to detect GC base pairs mutation. However, AT base pairs mutations or cross-linking mutations can not be excluded because of E.coli WP2 strains or S. typhimurium TA102 was not used according to latest version of OECD Guideline 471. In all strains tested negative results were observed with and without S9.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for genotoxicity under Directive 67/548/EEC.

 

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for genotoxicity under Regulation (EC) No. 1272/2008.