Registration Dossier
Registration Dossier
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EC number: 200-753-7 | CAS number: 71-43-2
Skin sensitisation
Administrative data
- 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.
Data source
Reference
- Reference Type:
- publication
- Title:
- Development and validation of an alternative dermal sensitization test: the mouse ear swelling test (MEST)
- Author:
- Gad SC, Dunn BJ, Dobbs DW, Reilly C and Walsh RD
- Year:
- 1 986
- Bibliographic source:
- Toxicology and Applied Pharmacology 84, 93-114
Materials and methods
Test guidelineopen allclose all
- 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)
Test material
- Reference substance name:
- Benzene
- EC Number:
- 200-753-7
- EC Name:
- Benzene
- Cas Number:
- 71-43-2
- Molecular formula:
- C6H6
- IUPAC Name:
- benzene
- Details on test material:
- At least 98% pure
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- 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%)
Challengeopen allclose all
- 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
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- other: Overall
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 µl
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
MEST: 0% sensitised, 100% swelling
GPMT: 0% sensitised
Applicant's summary and conclusion
- 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.
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