Registration Dossier

Toxicological information

Endpoint summary

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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:

Non-human information

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 toluene.


Migrated from Short description of key information:
The available animal data are sufficient to conclude that toluene is not a skin sensitiser. This is supported by the lack of human case reports for this high tonnage and widely used material.

Justification for selection of skin sensitisation endpoint:
Results from a guideline study provide no evidence of a potential to induce or elicit skin sensitisation

Respiratory sensitisation

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

No data animal or human data have been found with regard to respiratory sensitisation.


Migrated from Short description of key information:
No data have been found concerning respiratory sensitisation and there are no indications that toluene is a respiratory allergen.

Justification for selection of respiratory sensitisation endpoint:
No data have been found concerning respiratory sensitisation and there are no indications that toluene is a respiratory allergen

Justification for classification or non-classification

The animal data supported by the lack of human case studies reporting skin or respiratory sensitisation allow for the overall conclusion that, according to the GHS / CLP criteria, toluene does not require classification for sensitisation properties.