Registration Dossier

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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The substance has been assessed by exposure to guinea pigs and to humans. In both guinea pig studies, the substance has been observed to cause sensitisation by repeated insult. This observation is further supported by the review of data conducted by a technical committee of the WHO and included in this section.

The effects seen in guinea pigs would seem not, however, to be consistent with the effects observed when the substance was exposed to humans. Under the conditions of a repeated insult human volunteer test, the substance demonstrated a low background incidence of results but at levels that are considered to be not statistically significant and the substance was considered not sensitising under the conditions of the test. This observation is also supported by the review of data conducted by a technical committe of the WHO and included in this section.

Based on the data available and the observations of the WHO technical committee, it would seem likely that an interspecies difference exists with regard to the sensitising potential of the registered substance which might be due to guinea pigs being a more sensitive species to the substance or the substance being less readily absorbed by human skin.

Migrated from Short description of key information:
The sensitisation potential of the substance has been assessed to humans and guinea pigs

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
Respiratory sensitisation has not been assessed.

Justification for classification or non-classification

Given that classification and labelling of chemicals is, by definition, a mechanism for the communication of hazard to humans, it is considered justifiable to assume a greater weight of relevence to data collected from human exposure compared to the data collected from exposure to guinea pigs. It is, therefore, considered justifiable to classify the substance according to the data available from human data.

Based on data available from human exposure, the substance is considered to be not sensitising.

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