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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline compliant study, GLP status unknown, limitations in reporting but otherwise acceptable.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit

Test system

Type of coverage:
other: under exposure chamber
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Neat, 0.5 mL, to an area of 6cm2
Duration of treatment / exposure:
4 hours
Observation period:
144 h (i.e. 6 days) after end of application
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
> 2
Reversibility:
no data
Remarks on result:
other: erythema score 3.00 at 144 h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72
Score:
0
Reversibility:
fully reversible
Remarks on result:
other: oedema only seen at 1 h

Any other information on results incl. tables

Mean scores (Draize et al 1944):

Time after end of application

1 h

24 h

48 h

72 h

144 h

Mean score for erythema

1.00

2.00

2.20

2.40

3.00

Mean score for edema

2.20

0.00

0.00

0.00

0.00

 

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Benzene is considered to be irritating to rabbit skin (mean over 24/48/72 h for erythema >2)
Executive summary:

The irritation potential of benzene was assessed on the skins of six shaved rabbits exposed to neat benzene for 4 hours, using an exposure chamber of 6 cm2. One hour after exposure oedema grade 2 and erythema grade 1 were documented. No oedema, but mean scores of 2.0/2.2/2.4 for erythema were recorded at 24, 48, and 72 hours after the end of exposure. Erythema increased to a mean of grade 3 at 6 days.

It is concluded that benzene is irritating to rabbit skin and should be classified as Xi, R38. Under CLP it is proposed that the appropriate classification is Category 2, H315.