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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:
Not reported.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A non-GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.

Data source

Reference
Reference Type:
review article or handbook
Title:
Range Finding Toxicity Data: List VII
Author:
Smyth H, Carpenter C, Weil C,Pozzani U, Striegel J & Nycum J.
Year:
1969
Bibliographic source:
American Industrial Hygiene Association Journal 30:5, 470-476

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Four male rabbits were administered test material, which was held in contact with skin for an exposure period of 24 hours. Following exposure, animals were observed for 14 days. Signs of toxicity and mortality were recorded and skin reactions were assessed according to the Draize scale (Draize (1944), one-day cuff).
GLP compliance:
not specified
Test type:
other: not reported.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): 1,2-epoxycyclohexane

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 to 3.5 kg

No further information on test animals and environmental conditions is available.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE:
Prepared by clipping the fur from the entire trunk.

No further information on dermal exposure is available.
Duration of exposure:
24 hours, during which animals were immobilized.
No. of animals per sex per dose:
4 per dose
Control animals:
not specified
Details on study design:
- observation period of 14 days post exposure.
Statistics:
An approximate LD50 value was calculated according to the method detailed in Thompson (1947) using the table of Weil (1952). With a SD of ± 1.96.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
0.63 mL/kg bw
Based on:
test mat.
95% CL:
0.39 - 1.03

Any other information on results incl. tables

No further information on results is reported.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of the test material was reported to be 0.63 mL/kg. Using the density stated in Hawley et al (1977), which is 0.967 g/cm³, the recorded LD50 converts to 609.21 mg/kg.
Executive summary:

The acute dermal toxicity of the test material was determined by exposing 4 male New Zealand white rabbits, per dose, to the test material. The test material was fixed occlusively to the trunk of the test animals for 24 hours. Mortalities were recorded over an observation period of 14 days post exposure. The acute dermal LD50 was determined to be 0.63 ml/kg. Using the density stated in Hawley et al (1977), the LD₅₀converts to 609.21 mg/kg. According to Regulation 1272/2008 the test material requires classification as "category 3, H311: Toxic in contact with skin".