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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye 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 1500.42 Federal Hazardous Substances Act
Deviations:
not specified
Principles of method if other than guideline:
Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
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 / tissue source

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Test material was instilled into one eye of the test animal while the other eye remained untreated to serve as a control. The test material was not washed from the eyes.
Observation period (in vivo):
1, 2, and 3 days after administration (24, 48, and 72 hours)
Number of animals or in vitro replicates:
6 rabbits
Details on study design:
A dose of 0.1 ml of the test material was instilled in the right eyes of six healthy young adult albino rabbits. The untreated left eyes served as controls. The treated eyes were examined at 1, 2, and 3 days following instillation of the test material in accordance with the Draize method.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
3
Remarks on result:
other: Conjunctival redness and chemosis were not differentiated but were just grouped as conjunctival scores. The maximum score for chemosis is 4.

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 of this substance is not required for eye irritation.
Executive summary:

The eye irritation potential of the test substance was evaluated in rabbits. A dose of 0.1 ml of the test material was instilled in the right eyes of six healthy young adult albino rabbits. The untreated left eyes served as controls. The treated eyes were examined at 1, 2, 3, 4, and 7 days following instillation of the test material in accordance with the Draize method. No corneal opacity, iritis, conjunctival irritation was observed in any animal at any observation period. In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for eye irritation.