Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-guideline, non-GLP, animal experimental study, published in peer-reviewed literature. Pre-dates implementation of GLP and guideline but otherwise acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Comparative acute effects of some chemicals on the skin of rabbits and guinea pigs
Author:
Roudabush RL, Terhaar CJ, Fassett DW and Dziuba SP
Year:
1965
Bibliographic source:
Toxicol. Appl. Pharmacol. 7, 599-565

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: 21 CFR 191.10
Deviations:
yes
Remarks:
rabbit skin abraded, animals not immobilised for 24 hours, 4 rabbits/group, no mortality or clinical observations/ bodyweight or gross necropsy results reported. Guinea pigs also tested.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Source: P777 Eastman Organic Chemicals

Test animals

Species:
other: guinea pig and rabbit
Strain:
other: Hartley-derived guinea pigs, white rabbits
Sex:
male/female
Details on test animals and environmental conditions:
Guinea pigs: male Hartley-derived, 400-900 g
Rabbits: male or female (not specified) white, 1-4 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
A minimum of 3 doses used - details not reported
No. of animals per sex per dose:
4 animals/dose (sex not specified)
Control animals:
not required
Details on study design:
No other data available
Statistics:
LD50 was calculated by the method of Finney

Results and discussion

Effect levelsopen allclose all
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 9.4 mL/kg bw
Remarks on result:
other: rabbit abraded skin
Sex:
male
Dose descriptor:
LD50
Effect level:
> 9.4 mL/kg bw
Remarks on result:
other: guinea pig intact skin
Sex:
male
Dose descriptor:
LD50
Effect level:
> 9.4 mL/kg bw
Remarks on result:
other: guinea pig abraded skin

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 for benzene in the rabbit (applied to abraded skin) and the guinea pig (applied to intact abdominal or abraded back skin) was determined to be >9.4 mL/kg (8260 mg/kg) bodyweight.
Executive summary:

The acute dermal LD50 for benzene was determined in groups of 4 rabbits (abraded skin) or guinea pigs (abraded back skin or non-abraded abdominal skin) using occlusive dressings. 

The acute dermal LD50 was >9.4 mL/kg (8260 mg/kg) in each case.

In conclusion, benzene is of low acute dermal toxicity and does not warrant classification under Dir 67/548/EEC or GHS.