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Administrative data

Key value for chemical safety assessment

Additional information

The original sources of test substances in A1) and B1) tests are Nippon Shokubai and the original sources in A2) and B2) tests are other company. So, the result may be affected by the impurities in the test substance. However as this cannot be definitively proved, an appropriate in-vivo somatic cell genotoxicity study is being performed as triggered by REACH Annex VIII Section 8.4 Column 2.

Toxicity test

 Result

 Remarks

  Source of test substance Purity(%)

 Test Guideline

A1) bacterial reverse mutation assay (e.g. Ames test)

negative

10 ug/plate: where antibacterial activity were shown

 Nippon Shokubai>99.9%

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

A2) bacterial reverse mutation assay (e.g. Ames test)

Positive atTA98 and TA1537 with the non-activation method (-S9) .

Confirmation test:6 ug/plate or more are positive reaction 

Daihachi Chemical Industry>99.2%

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

B1) in vitro mammalian chromosome aberration test

 negative

test concentration: <= 5 ug/plate

  Nippon Shokubai>99.9%

OECD 473 

B2) in vitro mammalian chromosome aberration test

Positive at the additional high concentration test without metabolic activation

 

This positive result is considered as equivocal due to these positive findings generated only at fighly toxic/cytotoxic concentrations. (REACH Guidance R.7a R.7.4.1)

Daihachi Chemical Industry>99.2%

OECD 473 

C) in vivo micronucleus study

Negative at toxic doses

-

Nippon Shokubai>99.8%

OECD 474

 


Short description of key information:
Genetic toxicity data (Amest and Chromosome aberration) show negative with the test sample provided by NIPPON SHOKUBAI.
Genetic toxicity data (Amest and Chromosome aberration) show positive with the test sample provided by Daihachi Chemical. The positive result is considered as equivocal due to these positive findings generated only at highly toxic/cytotoxic concentrations. (REACH Guidance R.7a R.7.4.1)

As recommended in the REACH Guidance R.7a Table R.7.7-1, appropriate in vivo mutagenicity studies has been considered in case of another submitter whose purity is different from above 2 samples. The in vivo micronucleus study showed a negative result.

Therefore, PMI is considered as non-mutagenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The substance is not considered as mutagenic, and is therefore not classified in accordance with GHS.