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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
30 March 1975 - 21 April 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP, guideline study with limited details.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: US 16 CFR 1500.41 Federal Hazardous Substances Act
Deviations:
not specified
Principles of method if other than guideline:
A 0.5 ml portion of the test material was applied to the intact and abraded skin of six rabbits and covered with gauze patches and wrapped with an impervious material. After 24 hours the wrapping was removed and the treated areas were examined. Readings were also made at 72 hours.
GLP compliance:
no
Remarks:
Study predates GLP regulations.

Test material

Constituent 1
Chemical structure
Reference substance name:
Thiophene, tetrahydro-, 1,1-dioxide, 3-(C9-11-isoalkyloxy) derivs., C10-rich
EC Number:
800-172-4
Cas Number:
398141-87-2
Molecular formula:
Complex UVCB substance
IUPAC Name:
Thiophene, tetrahydro-, 1,1-dioxide, 3-(C9-11-isoalkyloxy) derivs., C10-rich
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Abraded and intact
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5ml/site
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
6 rabbits
Details on study design:
A 0.5 ml portion of the test material was applied to the intact and abraded skin of rabbits and covered with gauze patches and wrapped with an impervious material. After 24 hours the wrapping was removed and the treated areas were examined. Readings were also made at 72 hours.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
mean
Time point:
other: 24-72 hours
Score:
1.5
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
erythema score
Remarks:
Abraded skin
Basis:
mean
Time point:
other: 24-72 hours
Score:
1.5
Max. score:
4
Reversibility:
not reversible
Remarks:
within 72 hours
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No edema observed
Irritation parameter:
edema score
Remarks:
Abraded skin
Basis:
mean
Time point:
other: 24-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No edema observed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification is not required for skin irritation.
Executive summary:

The skin irritation potential of this substance was evaluated in rabbits. A 0.5 ml portion of the test material was applied to the intact and abraded skin of six rabbits and covered with gauze patched and wrapped with an impervious material. After 24 hours the wrapping was removed and the treated areas were examined. Readings were also made at 72 hours. Mean 24 -72 hours scores were determined to be 1.5 and 0 erythema, respectively, in both intact and abraded skin. In accordance with EU CLP Regulation (EC) No. 1272/2008, classification is not required for skin irritation.