Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute Toxicity: dermal

Currently viewing:

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
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
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

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
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 or test system 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:
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.