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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
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:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD Guideline 404 (1981); EEC Directive 84/449 (1984) Annex V-Method B4, EPA No.798 4470 (1990), MAFF No.4200 (1985)
GLP compliance:
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:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
other: Sterile codex liquid paraffin
Amount / concentration applied:

46 mg

Duration of treatment / exposure:
4h
Observation period:
Presumed to be 72 hrs
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Score:
0.3
Max. score:
2
Reversibility:
fully reversible
Remarks:
within 3 days
Remarks on result:
other: Maximum duration 48h; Maximum value at end of observation period 0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks:
within 3 days
Remarks on result:
other: Maximum duration 0 days; Maximum value at end of observation period 0.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is slightly irritating to the skin and is not classified according to EU CLP criteria.