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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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:
5 rats were administered a single oral dose of test material, by gavage, and observed for 14 days following treatment.
GLP compliance:
not specified
Test type:
other: Not reported.
Limit test:
no

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:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4-5 weeks
- Weight at study initiation: 90 - 120 g
- Fasting period before study: None
- Diet (e.g. ad libitum): Rockland rat diet

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Unchanged when possible, otherwise diluted in water or corn oil.
Doses:
Arranged in a logarithmic series differing by a factor of 2.
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
14 day observation period.
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:
1.09 mL/kg bw
Based on:
test mat.
95% CL:
0.66 - 1.8

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 of the test material in rats was determined to be 1.09 mL/kg. Using the density of 0.967g/cm³ from Hawley et al (1977) this converts to an LD50 of approximately 1054.03 mg/kg.
Executive summary:

The acute oral toxicity of the test material was determined by administering rats with oral varying doses of test material and observing them for 14 days following treatment for any signs of toxicity. Under the conditions of the study, the oral LD₅₀ of the test material in rats was determined to be 1.09 ml/kg. Using the density of 0.967g/cm³ from Hawley et al (1977) this converts to an LD₅₀

of approximately 1054.03 mg/kg

According to Regulation 1272/2008 the test material requires classification under acute oral toxicity "category 4, H302: Harmful if swallowed".