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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-01-22 to 1988-03-16

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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal 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
- Physical state: powder
- Analytical purity: 98.6%
- Purity test date: 1988-03-03
- Lot/batch No.: OP. 1/87-UO
- Expiration date of the lot/batch: December, 1992
- Stability under test conditions: stable for at least 2 hours

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG; CH 4414 Fuellinsdorf / Switzerland
- Age at study initiation: 14 - 15 weeks
- Weight at study initiation: 2.3 - 2.9 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 from Itingen, ad libitum.
- Acclimation period: Four days under test 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

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
The test article was applied moistened with distilled water.

Duration of treatment / exposure:

4 h

Observation period:

72 hours

Number of animals:

1 male
2 female

Details on study design:

TEST SITE
- Area of exposure: 3 cm x 3 cm
- Type of wrap if used: surgical gauze

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm tap water
- Time after start of exposure: 4h

SCORING SYSTEM:
according to OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

other: cumulative score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

8

Reversibility:

fully reversible

Irritant / corrosive response data:

- The test item showed a primary irritation score of 0.0 when applied to intact rabbit skin. Local signs (mean 1 hour to 72 hours) consisted of grade 0.0 erythema and grade 0.0 edema.
- In the area of application no staining of the treated skin by pigment or coloring of the test article was observed.
- No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin.

Other effects:

- The body weight gain of all rabbits was similar.
- No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred.
- 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:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Unter the conditions of this study, sodium 3(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was found to cause a primary irriatation scrore of 0.0 when applied to intact rabbit skin. The test item was not irritating to rabbit`s skin.

Executive summary:

Sodium 3(2H-benzotriazol-2-yl)-5-sec-butyl-4-hydroxybenzenesulfonate was tested in a primary skin irritation study according to OECD guideline 404 and EU method B.4. The single dose of 0.5 g/animal of test item was placed on the skin of rabbits (1 male; 2 females). The test item was found to cause a primary mean irritation score of 0.0 when applied to intact rabbit skin. Local signs (mean 1 hour to 72 hours) consisted of grade 0.0 erythema and grade 0.0 edema. In the area of application, no staining of the treated skin by pigment or coloring of the test article was observed. The test item was not irritating to rabbit`s skin.