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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1962
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data are given

Data source

Reference
Reference Type:
publication
Title:
Range-finding toxicity Data List VI
Author:
Smyth, H.F. et al.
Year:
1962
Bibliographic source:
Am. Ind. Hyg. Assoc. J. 23, 95-107

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
other: Modified Draize test
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 - 3.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
The fur of the male albino New Zealand rabbits was removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film.
The animals were immobilized during the 24-hours contact period, after which the film is removed and the rabbits are caged for the subsequent 14-Day observation period.
Duration of exposure:
24 h
Doses:
no data
No. of animals per sex per dose:
4 males
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson* using the tables of Weil**.

*Thompson, W. R.: Use of Moving Averages and Interpolation to Estimate Median Effective Dose. Bacteriol. Rev. 11: 115 (June 1947).

**Weil, C. S.: Tables for Convenient Calculation of median-Effective Dose (LD50 or ED50) and Instruction in Their Use. Biometrics 8: 249 (Sep 1952)

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
178 mg/kg bw
Based on:
test mat.
95% CL:
>= 0.13 - <= 0.24

Any other information on results incl. tables

Details of toxic effects not reported other than lethal dose value.

Result in publication is given as 0.2 mL/kg (0.15 - 0.27 mL/kg ).

Density used by the registrant for conversion: 0.89 g/mL

Applicant's summary and conclusion