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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzene
EC Number:
200-753-7
EC Name:
Benzene
Cas Number:
71-43-2
Molecular formula:
C6H6
IUPAC Name:
benzene

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.