Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
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)
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

MEST: 0% sensitised, 100% swelling

GPMT: 0% sensitised

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.

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).


Migrated from 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.


Migrated from 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 Dir 67/548/EEC or Regulation (EC) No 1272/2008 of the European Parliament.