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:

In classical animal assays for skin sensitisation such as the Magnusson-Kligman GPMT and the Buehler assay, kerosines and jet fuels did not trigger a positive response.

 

In the key dermal sensitisation study (Klimisch score=1; ARCO, 1992q), thermocracked kerosine in mineral oil was tested on male young adult Pig/Hartley guinea pigs using a modified Buehler technique. During the challenge phase, a second exposure of a 1:4 dilution of thermocracked kerosine to induced test animals did not yield higher response grades, severity, or incidence than those associated with the naive challenge control group exposed to thermocracked kerosine. During the challenge phase, exposure of 0.2% DNCB to induction positive control animals elicited significantly higher response grades, severity indices, and incidence over the naive DNCB challenge control group. The vehicle irritation control group was free of dermal irritation during the challenge phase. Therefore, under the conditions of this study, thermocracked kerosine is not considered a delayed contact sensitiser and DNCB induced an appropriate positive response.

 

In supporting studies (ARCO, 1992r; ARCO, 1992s; ARCO, 1992t; ARCO, 1992u; Kinkead et al., 1992; ARCO, 1986l; ARCO, 1986m; ARCO, 1986n; API, 1985a), kerosines were not found to be sensitisers to the skin of guinea pigs. In some of the studies (ARCO, 1992u; ARCO, 1986l; ARCO, 1986m; ARCO, 1986n), due to inherent irritative properties of the material, additional negative controls (challenge controls) were added at the challenge phase of the study. The irritation scores of the test material were compared to the challenge controls and only scores in excess of these controls were considered positive sensitisation responses.

 

Based on test data, there was no evidence of skin sensitisation; therefore, kerosine is not classified for skin sensitisation according to EU CLP Regulation (EC No. 1272/2008)

 

Additional data support that kerosines are not skin sensitisers (API, 1980a; API, 1984a; Kanikkannan et al., 2000). This information is presented in the dossier.

 


Migrated from Short description of key information:
In classical animal assays for skin sensitisation, kerosines and jet fuels did not trigger a positive response (similar to OECD 406).

Respiratory sensitisation

Endpoint conclusion
Additional information:

This endpoint is not a REACH requirement.


Migrated from Short description of key information:
This endpoint is not a REACH requirement.

Justification for classification or non-classification

Kerosines are not considered skin sensitisers based on the information presented above. Therefore, kerosines do not meet the criteria for classification as a dermal sensitiser under EU CLP Regulation (EC No. 1272/2008).