Sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-01-22 to 1988-02-26

Reliability:

1 (reliable without restriction)

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

NA

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate

EC Number:

403-080-9

EC Name:

Sodium 3-(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate

Cas Number:

92484-48-5

Molecular formula:

C16 H17 N3 O4 S .Na

IUPAC Name:

sodium 3-(2H-1,2,3-benzotriazol-2-yl)-5-(butan-2-yl)-4-hydroxybenzene-1-sulfonate

Details on test material:

- Name of test material (as cited in study report): FAT 75'309/A

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG; CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: By unique cage number and corresponding ear tags.
- Diet (e.g. ad libitum): Pelleted standard Kliba 341, rabbit maintenance diet , ad libitum
- Water (e.g. ad libitum): Community tap water, ad libitum
- Acclimation period: Four days under laboratory conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+ /- 3°C
- Humidity (%): 40-70 %
- Air changes (per hr): Air-conditioned with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye remained untreated and served as the reference control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g (The test article was applied undiluted.)

Duration of treatment / exposure:

single application

Observation period (in vivo):

21days

Number of animals or in vitro replicates:

3 (1 female + 2 males)

Details on study design:

The eyes of the animals were observed 24 hours prior to test article administration.
The test article (0.1 g per animal) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of the test article.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

233 male

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

234 male

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

235 female

Time point:

other: 24,48, 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

4

Reversibility:

not reversible

Results 5

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

233 Male

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

234 Male

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 7

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

(235 female)

Time point:

other: 24,48, 72 hours

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 7 days

Results 8

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

1

Max. score:

2

Reversibility:

fully reversible

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

233 male

Time point:

other: 24, 48, 72 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 10

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

234 male

Time point:

other: 24, 48, 72 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 11

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

235 female

Time point:

other: 24, 48, 72 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 12

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 13

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24,48, 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 14

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

234 male

Time point:

other: 24, 48, 72 hours

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 15

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48, 72 hours

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 16

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24,48, 72 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible

Results 17

Irritation parameter:

other: cumulative score

Basis:

animal #1

Remarks:

233 male

Time point:

other: 24, 48, 72 hours

Score:

4

Max. score:

13

Reversibility:

fully reversible within: 14 days

Results 18

Irritation parameter:

other: cumulative score

Basis:

animal #2

Remarks:

234 male

Time point:

other: 24, 48, 72 hours

Score:

5.3

Max. score:

13

Reversibility:

not reversible

Results 19

Irritation parameter:

other: cumulative score

Basis:

animal #3

Remarks:

235 female

Time point:

other: 24, 48, 72 hours

Score:

4.67

Max. score:

13

Reversibility:

fully reversible within: 14 days

Results 20

Irritation parameter:

other: cumulative score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

4.65

Max. score:

13

Reversibility:

not reversible

Irritant / corrosive response data:

- The test item showed a primary Irritation score of: 4.3, when applied to the rabbit eye mucosa.
- In the area of application no staining of the cornea and conjunctivae by pigment or coloring of the test article was observed.
- Slight corrosion on the cornea was observed in all animals within 48 hours to 72 hours and 48 hours to 21 days.

Other effects:

- No acute toxic symptoms were observed In the animals during the test period, and no mortality occurred.
- The body weight gain of all rabbits was similar.
- Due to the results obtained, no macroscopic organ examination was indicated.

Any other information on results incl. tables

NA

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye)

Remarks:

Migrated information Criteria used for interpretation of results: other: EU

Conclusions:

The test item was found to be severely damaging to the eyes, as corneal leasons were not reversible within 21 days in one of three treated rabbits.

Executive summary:

Sodium 3(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was tested in a primary eye irritation study according to OECD giudeline 405 and EU method B.5. The single dose of the test item (0.1 g per animal) was placed in the conjunctival sac of rabbit eyes. The test item was found to cause a primary irritation score of 4.3, when applied to the rabbit eye mucosa. The test item was found a mean cornea score of 1 (24/48/72 h), a mean iris score of 1 (24/48/72 h)

, a conjunctivae score of 2 (24,/48/72 h) and a chemosis score of 0.63 (24/48/72 h). No staining of the cornea and conjunctivae of the treated eyes by pigment or of test item was observed. Slight corrosion on the cornea was observed in all animals within 48- to 72 hours. The test item is severely damaging to rabbit eye, as irritation of one animal is irreversible within 21 days.