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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2015-09-01 ~ 2015-12-22
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-[cyclohexane-1,1-diylbis(4,1-phenyleneoxymethylene)]dioxirane
Cas Number:
13446-84-9
Molecular formula:
C24H28O4
IUPAC Name:
2,2'-[cyclohexane-1,1-diylbis(4,1-phenyleneoxymethylene)]dioxirane
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Control animals:
yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The test substance-related dead animals were not observed during study period.
Clinical signs:
One animal (Animal No. 2403) were observed crust formation from 6 days until 8 days and were recovered in 9 days after dosing.
Body weight:
In body weight of animals, two animals(Animal No. 2201, 2203) was decreased in 300
mg/kg B.W. (2nd step) on 3 days as compared with 1 day. And one animal(Animal
No. 2302) was decreased in 2000 mg/kg B.W. (3rd step) on 7 days as compared with 1, 3 days. One animal(Animal No. 2303) was decreased in 2000 mg/kg B.W. (3rd step) on 14 day as compared with 7 days.
Gross pathology:
the necropsy findings of animals, loss of fur were observed of external finding in 2000 mg/kg B.W. (4th step). Besides there were no necropsy findings caused by administration of test substance in all survived animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The present study, to investigate acute oral toxicity study of the SEZ-250 was conducted to the Sprague-Dawley (SD) rats. The test substance was administrated only one time by oral route at a dose of 300 mg/kg B.W. (1st, 2nd step) and 2000 mg/kg B.W. (3rd, 4th step). Three animals were used for each step and there were four steps in total. Mortality, clinical signs, body weight and necropsy findings were observed for 14 days.

The test substance-related dead animals were not observed during study periods.

Clinical signs (soiled perineal region, soft stool, loss of fur, crust formation) related with the test substance were observed and those signs were some individuals recovered for observation period at 300 mg/kg B.W. (1st, 2nd step) and 2000 mg/kg B.W. (3rd, 4th)

In body weight of animals, decrease was observed temporarily in 300 mg/kg B.W. (2nd step) and 2000 mg/kg B.W. (3rd step).

At necropsy, there were no lesions caused by administration of test substance.

Based on these results, the SEZ-250 was classified into GHS (Globally Harmonized Classification System for Chemical Substances and Mixtures) Category 5 (2000 mg/kg body weight < LD50 < 5000 mg/kg body weight) in this study.

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