(1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Body responsible for the test

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD GUIDELINE 401 (1987) 21 CFR 58 (FDA) C(81)30(Final)(OECD)

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Body responsible for the test

IUPAC Name:

Body responsible for the test

Test material form:

not specified

Test animals

Species:

rat

Strain:

other: Albino

Sex:

male/female

Administration / exposure

Vehicle:

corn oil

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 5 000 mg/kg bw

Any other information on results incl. tables

Mortality

Male: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Female: 5000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs

Signs of toxicity related to dose levels: Soft stools were noted in 2 females on the day of treatment only. This was not considered as remarkable.

Gross pathology

Effects on organs: No remarkable findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance showed no oral acute toxicity under the condition of the test.