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Administrative data

Key value for chemical safety assessment

Additional information

Table 7.6/1: Summary of genotoxicity tests

 

Test n°

Test / Guideline

Reliability

Focus

Strains tested

Metabolic activation

Test concentration

Statement

1

 

Thompson, 2004

Ames Test

(OECD 471)

K, rel. 1

Gene mutation

TA 1535

TA 1537

TA 98

TA 100

TA 102

-S9

+S9

Up to 5000 µg/plate

-S9 : non mutagenic

+S9 : non mutagenic

2

 

Morris, 2008

HL CAT

(OECD 473)

K, rel. 1

Chromosomal aberration

Human Lymphocytes

-S9

+S9

Up to 180 µg/mL (up to cytotoxicity)

-S9 : non clastogenic

+S9 : non clastogenic

 

Gene mutation Assay (Tests n° 1):

A Bacterial Reverse mutation Assay (Ames test) was performed according to OECD test guideline No 471 and in compliance with GLP with the test material (See Table 1). No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either in the presence of absence of metabolic activation. The test indicates that the test material does not induce gene mutations in bacteria whereas all positive control chemicals (with and without metabolic activation) induced significant increase of colonies. The test material is therefore considered as non-mutagenic according to the Ames test.

 

Chromosomal aberration (Test n°2)

The clastogenic potential of the test material was determined using an in vitro chromosome aberration test in human lymphocytes, which measures the potential of a substance to increase the incidence the of structural chromosome aberrations in cultured human lymphocytes.

None of the dose levels up to the cytotoxicity limit with the test material, either in the presence or absence of metabolic activation, induced significant increases in the frequency of cells with aberrations in either of two experiments. The test material does not induce structural aberrations in the chromosomes of human lymphocytes under activation and non-activation conditions, whereas both positive control chemicals (with and without metabolic activation) induced significant increases in the frequency of aberrant cells. The test material is therefore considered as negative for inducing chromosomal mutations in human lymphocyte cells under activation and non-activation conditions used in this assay.


Justification for selection of genetic toxicity endpoint
No study was selected since both studies were negative.

Short description of key information:
- Ames test (OECD 471, GLP, K, rel. 1): non mutagenic up to limit concentration in S. typhimurium TA 1535, TA 1537, TA 98, TA 100, and TA102
- CAT (OECD 473, GLP, K, rel.1): not clastogenic up to cytotoxic concentration in human lymphocytes cells.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification for human health according to the Regulation (EC) No. 1272/2008 including the ATP3.

Self-classification:

Based on the available information, no additional classification is proposed according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and of the Directive 67/548/EEC.