2-(2H-Benzotriazol-2-yl)-6-(1-methyl-1-phenylethyl)-4-(1,1,3,3-tetramethylbutyl)phenol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06-Nov-1996 to 14-Nov-1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study (OECD test guideline 404)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted on 17-Jul-1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

422-600-5

EC Name:

-

Cas Number:

73936-91-1

Molecular formula:

C29H35N3O

IUPAC Name:

2-(2H-1,2,3-benzotriazol-2-yl)-6-(2-phenylpropan-2-yl)-4-(2,4,4-trimethylpentan-2-yl)phenol

Details on test material:

- Description: off white solid
- Analytical purity: 99.35-99.45 %
- Storage: at room temperature, away from light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Birkendorferstrasse 65, 88397 Biberach/Riss, Germany
- Age at study initiation: 15 weeks
- Weight at study initiation: 3.0 kg (male), 3.0-3.1 kg (females)
- Housing: individually, in stainless steel cages
- Diet: pelleted standard rabbit maintenance diet (Kliba 341, Kliba Mühlen AG, 4303 Kaiseraugst, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 40-70 %
- Air changes: 10-15 changes/hour
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: 06-Nov-1996 to 14-Nov-1996

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: moistened with bi-distilled water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

at least 72 hours

Number of animals:

1 male, 2 female rabbits

Details on study design:

TEST SITE
- Area of exposure: dorsal
- Area of exposure: 6 cm²
- Type of wrap if used: surgical gauze patch with semi-occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
The skin reaction was assessed according to the numerical scoring system listed in Directive 93/21/EEC (according to Draize, 1959) at approximately 1, 24, 48 and 72 hour(s) after the removal of the dressing, gauze patch and test item.
Minimal score: 0, maximal score: 4 (erythema and eschar formation, oedema formation)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(male)

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: individual mean score

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(female)

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: individual mean score

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(female)

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: individual mean score

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(male)

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: individual mean score

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(female)

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: individual mean score

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(female)

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Remarks on result:

other: individual mean score

Results 7

Irritation parameter:

overall irritation score

Basis:

animal: #1, #2, #3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

8

Remarks on result:

other: calculated value

Irritant / corrosive response data:

The test item showed no irritant or corrosive potential.

Other effects:

No clinical signs of systemic toxicity were observed during the test and observation period, and no mortality occurred. No staining of the treated skin by the test item was observed. The body weight gain of all rabbits was within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, the test article is regarded as not irritating to the rabbit skin.

Executive summary:

The primary skin irritation potential of the test article was investigated by semiocclusive, topical application of 0.5 g onto 6 cm² intact dorsal skin of each of three young adult New Zealand rabbits. After 4 hours, the test item was removed with lukewarm water. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion. The primary irritation score was calculated by totaling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of figures. Under the conditions of this experiment, the test substance was found to cause a primary irritation score of 0.00 (max. 8.0) when applied to healthy intact rabbit skin. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No clinical signs of systemic toxicity were observed during the test and observation period, and no mortality occurred. No staining of the treated skin by the test item was observed. The body weight gain of all rabbits was within the normal range of variability. No corrosive effects were noted on the treated skin of any animal at any measuring interval. Based on the results of this study, the test article is regarded as not irritating to the rabbit skin.