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Toxicological information

Skin sensitisation

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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:
1986
Bibliographic source:
Toxicology and Applied Pharmacology 84, 93-114

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
only 15 test and 6 control animals in GMPT
Qualifier:
no guideline available
Deviations:
not applicable
Remarks:
Validation study for MEST
GLP compliance:
not specified
Type of study:
other: GPMT and mouse ear swelling test (MEST)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
At least 98% pure

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

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
Remarks:
Migrated information
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 Dir 67/548/EEC or GHS.