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Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

Reaction mass of methyl chloroacetate and chloroacetic acid:

1.- Monochloroacetic acid:

The only information available on the sensitizing properties of this substance is a short description of a sensitization study. However, due to the limited reporting, this study is not considered reliable for the evaluation of the sensitizing potential of the substance.

According to column 2 of REACH Annex VII, a sensitisation study does not need to be conducted since the substance is classified as corrosive to the skin.

2.- Methyl chloroacetate:

Based on the QSAR estimation using the OECD Toolbox v1.1, the substance is considered to be a skin sensitiser. Furthermore, as published in an article, the analogue monochloro acetic acid ethyl ester (EMCA) was tested in the Guinea Pig Maximization Test (Magnusson and Kligman) to determine its possible sensitizing potential. EMCA showed the capacity to sensitize 5 of 20 guinea pigs. On day 49, cross-reaction patterns to the methyl ester of MCA (MMCA) were studied in four animals. All animals reacted to MMCA (5%-0.5%). EMCA is concluded to be a sensitizer to humans. Cross reactivity to MMCA may occur. According to the CLP Regulation, the substance is classified as Skin Sensitizer Category 1.


Migrated from Short description of key information:
Skin sensitisation: Reaction mass of methyl chloroacetate and chloroacetic acid: Data waiving: According to column 2 of REACH Annex VII, the study does not need to be conducted since the substance is classified as corrosive to the skin.

Monochloroacetic acid: the only information available on the sensitizing properties of this substance is a short description of a sensitization study. However, due to the limited reporting, this study is not considered reliable for the evaluation of the sensitizing potential of the substance.

Methyl chloroacetate: Weight of evidence: Read across from results published in an article with the analogue monochloro acetic acid ethyl ester and QSAR estimation using the OECD Toolbox.

Justification for classification or non-classification

Monochloroacetic acid:

No data for the evaluation of the sensitizing potential of the substance.

According to column 2 of REACH Annex VII, a sensitisation study does not need to be conducted since the substance is classified as corrosive to the skin.

Methyl chloroacetate:

Skin Sensitizer Category 1.

Conclusions:

Based on the skin sensitisation data for the substances mentioned above and their concentrations, the following classification is proposed following the classification criteria for mixtures included in the CLP Regulation:

Skin sensitizer Category 1 (since methyl chloroacetate is present in a concentration of more than 1%).