Registration Dossier

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 read-across substances have been determined to be sensitisers in guinea pig patch tests.

The test material and read-across substances have been determined to be non-sensitisers in human patch tests.

 

The two read-across substances were determined to be dermal sensitisers on the basis of data from studies using guinea pigs as the test organism. Two of these studies were performed using sodium 4-icosylbenzenesulfonate, where guinea pigs were exposed to the test material in a Buehler test that was performed under GLP conditions and in accordance with standardised guidelines. The second read-across substance was sodium salt of sulfonated C15-C18 n-alpha-olefin; observations of in vivo exposure to guinea pigs were reported by atechnical committee of the WHO.

The effects seen in guinea pigs would not seem, however, to be consistent with the effects observed when humans were exposed to the substance. Human observations as a result of exposure to these two read-across substances show that they are in fact not sensitisers to humans. Low background incidences of sensitisation were observed among human volunteers, however, at levels that are considered to be not statistically significant. This lack of sensitisation in humans is further supported by human observations after exposure to the substance to be registered. Human sensitisation studies have been reported under ‘Exposure related observations in humans’.

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.

Based on the weight of evidence provided, the test material is considered to be not sensitising.


Migrated from Short description of key information:
The read-across substances have been determined to be sensitisers in guinea pig patch tests.
The test material and read-across substances have been determined to be non-sensitisers in human patch tests.

Justification for selection of skin sensitisation endpoint:
The skin sensitisation endpoint has been addressed on a weight of evidence basis and thus one study cannot be selected over the other. Three guinea pig studies using two different structural analogues or surrogates have been provided. Two of the studies were performed using sodium 4-icosylbenzenesulfonate, under GLP conditions and in accordance with standardised guidelines with minor deviations. Accordingly these studies have been assigned a reliability score of 2 in line with the principles of Klimisch et al. (1997). The third study is taken from a World Health Organization (WHO) publication using sodium salt of sulfonated C15-C18 n-alpha-olefin; this report is considered to be of good quality and of sound reliability and has been assigned a reliability score of 2 in line with Klimisch et al. (1997).
Human data presented under the endpoint “Sensitisation data (humans)” is also a key part of the weight of evidence for this endpoint. Two repeat insult patch tests using the substance to be registered and a further two studies performed on the read-across substances sodium 4-icosylbenzenesulfonate and sodium salt of sulfonated C15-C18 n-alpha-olefin, have also been provided to support the sensitisation dataset.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
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 relevance 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 exposure.

Based on data available from human exposure, the substance is considered to be not sensitising in accordance with Regulation (EC) No. 1272/2008.