(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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

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

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum. Therefore the reliability statement below can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

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

Details on test material:

This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Test animals

Species:

rabbit

Strain:

other: New Zealand hybrid albino rabbit

Details on test animals or test system and environmental conditions:

This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Vehicle:

other: Sterile Codex liquid paraffin

Controls:

other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Amount / concentration applied:

46 mg

No other details provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Duration of treatment / exposure:

4 hours

Observation period:

This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Number of animals:

6

Details on study design:

This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Results and discussion

In vivo

Results

Irritation parameter:

erythema score

Basis:

mean

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: observation period

Remarks on result:

other: Maxium duration: 48 hrs. Maximum value at end of observation period: 0

Irritant / corrosive response data:

Reversibility of any observed effects: Changes fully reversible within 3 days.

Other effects:

This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance has been determined not to be a dermal irritant to rabbit skin.

Executive summary:

All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant.

Dermal irritation assessed by using OECD Guideline 404 (1981) EEC Directive 84/449 (1984) - Annex V - Method B4

T-1540N was demonstrated not to be a dermal irritant.