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Diss Factsheets
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EC number: 200-753-7 | CAS number: 71-43-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Endpoint summary
Administrative data
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.
There is no evidence from animal experimental inhalation studies, or from human experience, to indicate that benzene is a respiratory sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-guideline, non- GLP animal experimental study, limitations in design and reporting but otherwise adequate for assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- only 15 test and 6 control animals in GMPT
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
- Type of study:
- other: GPMT and mouse ear swelling test (MEST)
- Species:
- other: mouse and guinea pig
- Strain:
- other: CF-1 mouse and Hartley guinea pigs
- Sex:
- not specified
- Details on test animals and environmental conditions:
- Specific details for benzene cannot be deduced from paper
- Route:
- intradermal and epicutaneous
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- MEST: Induction and challenge neat (100%)
GPMT: Intradermal injection and topical induction application and challenge application neat (100%) - Route:
- epicutaneous, semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- MEST: Induction and challenge neat (100%)
GPMT: Intradermal injection and topical induction application and challenge application neat (100%) - No. of animals per dose:
- MEST: 10- 15 females per test group, 5-10 control group
GPMT: 15 per test group, 6 in control group - Key result
- Reading:
- other: Overall
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 µl
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- not sensitising
- Conclusions:
- Under the conditions of the MEST and limited GPMT studies described, benzene was not a skin sensitizer.
- Executive summary:
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.
It is concluded that benzene is not a strong sensitizer and does not warrant labelling under CLP or GHS.
Reference
MEST: 0% sensitised, 100% swelling
GPMT: 0% sensitised
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).
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.
Justification for classification or non-classification
It is concluded that benzene is not a skin or respiratory sensitiser and does not warrant labelling under (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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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