(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

Endpoint summary

Description of key information

The test substance is of very low acute toxicity to rats, using EU Annex V test methods.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A study summary was made available by ECHA under Article 25, Para 3., of EC Regulation 1907/2006.

Qualifier:

according to guideline

Guideline:

other: Annex V, 92/69/EEC, B1

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Crl CDBR

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

corn oil

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

Males: 5000 mg/kg bw.; number of animals 5; number of deaths 0
Females: 5000 mg/kg bw.; number of animals 5; number of deaths 0

Clinical signs:

The only sign of toxicity was soft stools in two females on the day of treatment.

Body weight:

All animals showed expected gains in bodyweight over the treatment period.

Gross pathology:

There were no effects observed.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

There were no deaths and no significant signs of reaction to treatment at the limit test dosage of 5000 mg/kg bw. The test substance is therefore considered to be practically non-toxic and is not classified according to CLP criteria.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Good

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A study summary was made available by ECHA under Article 25, Para 3., of EC Regulation 1907/2006

Qualifier:

according to guideline

Guideline:

other: Annex V

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Type of coverage:

semiocclusive

Vehicle:

arachis oil

Details on dermal exposure:

The substance as supplied was applied to the skin which was moistened with arachis oil BP for 24h under semi-occlusive bandages.

Duration of exposure:

24h

Doses:

5000 mg/Kg bw.

No. of animals per sex per dose:

Male rats: 5
Female rats: 5

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male rats: 0
female rats: 0

Clinical signs:

No systemic effect and no signs of dermal irritation.

Body weight:

No effect

Gross pathology:

No abnormalities observed.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance caused no local or systemic dermal acute toxicity under the conditions of this test.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Good

Additional information

In an acute oral toxicity study in rats (Corning Hazleton Laboratories Ltd., 1993) the test substance was administered in corn oil to five male and five female Sprague Dawley rats at a dosage of 5,000 mg/kg/ bw, and observed for 14 days. There were no deaths, no clinical signs, no effects on bodyweight and no remarkable macropathological findings. .

In the key acute dermal toxicity study (Safepharm Laboratories Ltd, 1998), the test substance was applied under semi-occlusive bandages to the arachis oil moistened skin of five male and five female Sprague Dawley rats at a dosage of 2,000 mg/kg bw, and observed for 14 days. There were no deaths, no systemic or local signs, and no remarkable pathological findings.

In view of the very low acute oral and dermal toxicity and mild irritancy of the test substance, it is not expected to pose an acute inhalation hazard.

Justification for selection of acute toxicity – oral endpoint
Only one acute oral toxicity study is available.

Justification for selection of acute toxicity – inhalation endpoint
The conduct of an acute inhalation toxicity study is considered scientifically unjustified

Justification for selection of acute toxicity – dermal endpoint
The more recently undertaken of two good quality, GLP, acute dermal limit test studies conducted to Annex V test guidelines

Justification for classification or non-classification

The available animal test data are reliable and suitable for classification purposes under regulation 1272/2008. The substance is not therefore classified for single dose specific target organ toxicity under EU CLP criteria.