Registration Dossier
Registration Dossier
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EC number: 265-100-0 | CAS number: 64741-99-7 A complex combination of hydrocarbons obtained as the extract from a solvent extraction process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8 and boiling in the range of approximately 80°C to 145°C (176°F to 293°F). This stream is likely to contain 10 vol. % or more benzene.
Endpoint summary
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
Although there are no GLP guideline compliant studies the skin sensitisation potential of benzene was assessed in a mouse ear swelling test (MEST) and a reduced guinea pig maximisation test (GPMT) using neat benzene. None of the mice and none of the guinea pigs showed any evidence of sensitisation (Gad et al, 1986).
Human information
In a study using 25 male volunteers a maximisation test with induction using 50% benzene and challenge with 20% benzene no evidence of skin sensitisation was seen (0/25) (Kligman, 1966).
Short description of key information:
Based on limited animal and human experimental data, and no reports in humans of skin sensitisation, benzene is considered not to be a skin sensitiser. As benzene is a mutagen and a carcinogen, human exposure is minimised by the implementation of appropriate risk management measures. Benzene is produced and used under strictly controlled conditions.
Justification for selection of skin sensitisation endpoint:
Benzene was not a dermal sensitiser when assessed in a mouse ear swelling test (MEST) and a guinea pig maximisation test (GPMT). No evidence of skin sensitisation was found in a human maximisation test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Non-human information
There is no evidence from animal experimental studies that benzene is a respiratory sensitiser
Human Information
There are no reports of human respiratory sensitisation to benzene despite more than 100 years of human experience with benzene which was commonly used as a solvent. As benzene is a mutagen and a carcinogen, human exposure is minimised by the implementation of appropriate risk management measures. Benzene is produced and used under strictly controlled conditions.
Short description of Key information
There is no evidence from animal experimental inhalation studies, or from human experience, to indicate that benzene is a respiratory sensitiser.
Justification for classification or non-classification
It is concluded that benzene is not a skin or respiratory sensitiser and does not warrant labelling under Regulation (EC) No 1272/2008 of the European Parliament.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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