Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

Skin sensitisation

Non-human information

In a study using methodology based on Buehler, the sensitization potential of CAS 68516-20-1 was investigated in groups of 10 male guinea pigs dermally exposed to a 1:2 v/v dilution of 0.5 mL in mineral oil for each of 3 induction phases. Following challenge with a 1:4 dilution response grades, severity and incidence were not greater than those at the control group site. It was concluded that CAS 68516-20-1 was not a skin sensitiser.

CAS 6471-68-0 was investigated for sensitisation potential using a method based on Buehler. Groups of 10 guinea-pigs were induced on 3 occasions at 1 week intervals using concentrations of 50% in paraffin oil and challenged using 25% in paraffin oil. Following challenge, very slight erythema (grade 1) was seen in 2 animals in the test group. These reactions did not exceed the highest reaction of the naïve controls. CAS 64741-68-0 was not a sensitiser.

A maximisation test in accordance with EU guideline B6 (Skin sensitisation) was performed by NOTOX (1996) to assess the sensitisation potential of toluene in guinea pigs. A grade 1 reaction (discrete or patchy erythema) was seen in 1/20 tested animals in response to challenge with a 50% solution. No other skin reactions were observed. It was concluded that toluene was not a skin sensitiser in this study.

Human information

There are no reports of skin sensitisation in humans attributed to low benzene naphtha streams or toluene.

NOTOX (1996). Assessment of contact hypersensitivity to toluene in the albino guinea pig (Maximization test). Testing laboratory: NOTOX, s'Hertogenbosch, The Netherlands. Report no.: 179911. Owner company: Shell. Report date: 1996-11-21.


Migrated from Short description of key information:
The available animal data are sufficient to conclude that members of the low benzene naphtha category are not skin sensitisers. Toluene is not a skin sensitiser in animals and there are no reports of skin sensitisation attributed to toluene in humans.

Respiratory sensitisation

Endpoint conclusion
Additional information:

No animal or human data have been found with regard to respiratory sensitisation of low benzene naphtha streams or of the specific component, toluene.


Migrated from Short description of key information:
There are no data on respiratory sensitisation for the low benzene naphtha streams or toluene, but there is no evidence that they require classification for sensitisation properties.

Justification for classification or non-classification