Benzenesulfonic acid, C10-60-alkyl derivs., barium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 09 February 1981 and 16 February 1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Section 1500.42 Federal Hazardous Substances Act Regulations - CFR 16 P. 125.

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

61789-86-4

IUPAC Name:

61789-86-4

Constituent 2

Reference substance name:

Sulfonic acids, petroleum, calcium salts

EC Number:

263-093-9

EC Name:

Sulfonic acids, petroleum, calcium salts

IUPAC Name:

263-093-9

Details on test material:

Identification: OS#47860
Date received: 28 January 1981

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Six healthy young adult albino rabbits were used in this study.
The animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye remained untreated and was used for control purposes.

Amount / concentration applied:

0.1 gm of the experimental material was instilled into the right eye.

Duration of treatment / exposure:

The test material was not washed from the eyes.

Observation period (in vivo):

The treated eyes were examined at one, two, three, five and seven days following instillation of the test material into the eyes.

Number of animals or in vitro replicates:

6

Details on study design:

Six healthy young adult albino rabbits were used in this study.
0.1 gm of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The test material was not washed from the eyes.
The treated eyes were examined at one, two, three, five and seven days following instillation of the test material into the eyes. Interpretation of the results was made in accordance with the Draize Scale of Scoring Ocular Lesions - see attachment 1.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Day 1

Score:

0

Max. score:

110

Reversibility:

other: No effects observed

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Day 2

Score:

0

Max. score:

110

Reversibility:

not specified

Remarks:

No effects observed

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Day 3

Score:

0

Max. score:

110

Reversibility:

other: No effects observed

Results 4

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Day 5

Score:

0

Max. score:

110

Reversibility:

other: No effects observed

Results 5

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: Day 7

Score:

0

Max. score:

110

Reversibility:

other: No effects observed

Irritant / corrosive response data:

Based on the accompanying table, the subject material is not a primary irritant within the definition of the Act Reference Section 1500.42 (b) (1) (2), and requires no cautionary labeling with respect to that section.

See Table 1 - attachment 2

Any other information on results incl. tables

See Table 1 - attachment 2

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: Based on the accompanying table, the subject material is not a primary irritant within the definition of the Act Reference Section 1500.42 (b) (1) (2), and requires no cautionary labeling with respect to that section.

Conclusions:

Based on the accompanying table, the subject material is not a primary irritant within the definition of the Act Reference Section 1500.42 (b) (1) (2), and requires no cautionary labeling with respect to that section.

Executive summary:

To determine the degree of irritation,if any, which the subject material may produce when instilled into the eyes of albino rabbits.

Six healthy young adult albino rabbits were used in this study. 0.1 gm of the experimental material was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The test material was not washed from the eyes. The treated eyes were examined at one, two, three, five and seven days following instillation of the test material into the eyes. Interpretation of the results was made in accordance with the Draize Scale of Scoring Ocular Lesions.

Based on the accompanying table, the subject material is not a primary irritant within the definition of the Act Reference Section 1500.42 (b) (1) (2), and requires no cautionary labeling with respect to that section.