A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 21, 1990 - August 24, 1990

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive

GLP compliance:

yes

Remarks:

Experimental Toxicology CIBA-GEIGY Limited 4332 Stein / Switzerland

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates

EC Number:

407-000-3

EC Name:

A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates

Cas Number:

127519-17-9

Molecular formula:

C27 H37 N3 O3

IUPAC Name:

heptyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate; nonyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate; octyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate

Details on test material:

- Physical state: liquid, viscouse
- Analytical purity: 98%
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Age at study initiation: approx. 9 - 13 weeks
- Weight at study initiation: 2580 to 2720 g
- Housing: individually in metal cages
- Diet: standard pellet, Nafag No. 814 e.g. ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: Control gauze patches moistened with distilled water were applied to the contralateral flanks.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL water
- Concentration (if solution): 100%

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 hours

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: right flank
- Type of wrap if used: gauze patch covered loosley with aluminum foil and held in place by an adhesive tape

SCORING SYSTEM: OECD scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: minimal reactions at the 1 hour mark in one animal

Irritant / corrosive response data:

The test substance induced minimal erythema and edema reactions revesible within 48 hours.

Any other information on results incl. tables

Individual Irritation Scores:

		Erythema	Edema
1 h	728	1	0
	723	1	0
	706	1	1
24 h	728	1	0
	723	0	0
	706	1	0
48 h	728	0	0
	723	0	0
	706	0	0
72 h	728	0	0
	723	0	0
	706	0	0
mean 24 - 72 h	728	0.3	0.0
	723	0.0	0.0
	706	0.3	0.0
mean 24 - 72 h		0.2	0.0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test article caused minimal dermal reactions below the threshold of significance and is therefore regarded as not irritating to the rabbit skin.

Executive summary:

In an acute dermal irritation/corrosion study following OECD guideline 404 and in compliance with GLP, three New Zealand White rabbits were exposed to 0.5 ml of the test substance. A gauze patch (approx.12-16 cm) bearing the test article was applied to the right flank of each animal. A control gauze patch was applied to the contralateral flank. Both patches were moistened before application with test material. The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape. The animals were checked daily for systemic symptoms and mortality. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. Under the experimental conditions employed the test substance induced mild erythema and edema reactions revesible within 48 hours when applied to the clipped albino rabbit skin. Because the mean values of the recordings 24 to 72 hours after application are below the threshold of significance, the test article is considered as not irritating to the rabbit skin.