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: Study pre-dates GLP and guideline development and has limitations in design and reporting but otherwise acceptable for assessment.

Data source

Reference
Reference Type:
publication
Title:
Range-finding toxicity data: List VII
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Streigel JA and Nycum JS,
Year:
1969
Bibliographic source:
American Industrial Hygiene Association Journal 30, 470-476

Materials and methods

Principles of method if other than guideline:
Study investigated mortality in groups of 4 male rabbits exposed for 24 hours. No further details are provided but gives adequate relative guide to LD50.
GLP compliance:
no
Test type:
other:
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Toluene
EC Number:
203-625-9
EC Name:
Toluene
Cas Number:
108-88-3
Molecular formula:
C7H8
IUPAC Name:
toluene
Details on test material:
- no data

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 to 3.5 kg

No other data provided

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 hours
Doses:
- no data
No. of animals per sex per dose:
4 males
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
95% CL:
9.63 - 20.77
Remarks on result:
other: LD50 quoted as 14.1 mL/kg (12267 mg/kg using density of 0.87)

Any other information on results incl. tables

LD50 quoted as 14.1 mL/kg (9.63 -20.77)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 value of 14.1 mL/kg (9.63-20.77), corresponding to 12267 g/kg (8.38-18.07).
Executive summary:

Acute dermal toxicity in the rabbit was found to be low (LD50 >5000 mg/kg). Toluene does not warrant classification under GHS / CLP.