(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: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

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:

Sprague-Dawley

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

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

The substance as supplied was applied to skin which was moistened with arachid oil B.P.

Duration of exposure:

24h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males
5 females

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:

> 2 000 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

No signs of systemic toxicity were notet during the study period.

Body weight:

No toxicologically significant effects on bodyweight were noted during the study.

Gross pathology:

Effects on organs: No abnormalities were noted at necropsy of animas killed at the end of the study.

Other findings:

Signs of toxicity (local): no signs of dermal irritation were noted during the study.

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] is not classified for acute toxicity via the dermal route of exposure (LD50 > 2000 mg/kg bw).

Executive summary:

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

The acute dermal toxicity to rats has been determined according to the EU Method B.3, and in compliance with GLP.

A limit test was performed and a single dose of 2000 mg/kg was received by rats, 5 males and 5 femelles.

No mortality occured and no signs of systemic toxicity 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 dermal route of exposure according to the criteria of DSD and CLP (LD50 > 2000 mg/kg bw).