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Toxicological information

Acute Toxicity: dermal

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Administrative data

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

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:
other: Annex V
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
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 animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

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

Results and discussion

Effect levels
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.

Applicant's summary and conclusion

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.