Thiophene, tetrahydro-, 1,1-dioxide, 3-(C9-11-isoalkyloxy) derivs., C10-rich

Endpoint summary

Description of key information

SKIN
Not irritating; study performed in line with US 16 CFR 1500.3 Federal Hazardous Substances Act; Gabriel (1975b)
EYE
Not irritating; study performed in line with US 16 CFR 1500.3 Federal Hazardous Substances Act; Gabriel (1975c)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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.

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.

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No data

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.

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

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.

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Reference 3

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

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.

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.

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data

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.

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.

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.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin

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 for erythema and edema, respectively, in both intact and abraded skin. In accordance with EU CLP Regulation (EC) No. 1272/2008, classification is not required for skin irritation.

Eye

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 and 3 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.

Justification for selection of skin irritation / corrosion endpoint:
The available study is reliable and can support the development of a chemical safety assessment.

Justification for selection of eye irritation endpoint:
The available study is reliable and can support the development of a chemical safety assessment.

Justification for classification or non-classification

The substance does not require classification in accordance with the criteria specified in either Regulation 1272/2008 or Directive 67/546/EEC.