(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

Study period:

no date

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: All information in this endpoint has been provided by the ECHA using the 12 years rule. This data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

413-110-2

EC Name:

-

Cas Number:

135861-56-2

Molecular formula:

C24H30O6

IUPAC Name:

(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

Test material form:

not specified

Details on test material:

This information is not provided in the migrated NONS file provided by ECHA.

Test animals

Species:

rat

Strain:

other: Albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

This information is not provided in the migrated NONS file provided by ECHA.

Administration / exposure

Route of administration:

other: This information is not provided in the migrated NONS file provided by ECHA.

Vehicle:

corn oil

Details on oral exposure:

This information is not provided in the migrated NONS file provided by ECHA.

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 males
5 femelles

Control animals:

other: This information is not provided in the migrated NONS file provided by ECHA.

Details on study design:

This information is not provided in the migrated NONS file provided by ECHA.

Statistics:

This information is not provided in the migrated NONS file provided by ECHA.

Results and discussion

Preliminary study:

This information is not provided in the migrated NONS file provided by ECHA.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Male & femelle (5000 mg/kg bw); Number of animalss: 5 of each sex; Number of deaths : 0

Clinical signs:

Signs of toxicity related to the dose (5000 mg/kg bw) : soft stools in 2 females the day of treatment. This was not considered as remarkable.

Body weight:

This information is not provided in the migrated NONS file provided by ECHA.

Gross pathology:

Effects on organs : no remarkable findings.

Other findings:

This information is not provided in the migrated NONS file provided by ECHA.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item [1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol] was not classified for acute toxicity via the oral route of exposure (LD50 > 5000 mg/kg bw).

Executive summary:

All information in this endpoint has been provided by the ECHA using the 12 year rule.

The acute oral toxicity to rats has been determined according to OECD Guideline 401 and in compliance with GLP.

A limit test was performed and a single dose of 5000 mg/kg was received by rats, 5 males and 5 femelles.

No mortality occured and no remarkable clinical signs or effects on organs were observed.

The test item [1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol] is not classified for acute toxicity via the oral route of exposure according to the criteria of DSD and CLP (LD50 > 5000 mg/kg bw).