Sodium 5-N-butylbenzotriazole

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09-08-1988 - 22-08-1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline 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:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 5-N-butylbenzotriazole

EC Number:

404-450-2

EC Name:

Sodium 5-N-butylbenzotriazole

Cas Number:

118685-34-0

Molecular formula:

CCCCc1ccc2c(c1)nnn2[Na]

IUPAC Name:

sodium 5-butyl-1H-1,2,3-benzotriazol-1-ide

Details on test material:

Identification: Butyl benzotriazole, sodium salt
Physical state: dark brown solid
Purity: 82%

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
- Expiration date of the lot/batch:
- Purity test date:


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored at ambient temperature
- Stability under test conditions:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:

FORM AS APPLIED IN THE TEST (if different from that of starting material)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Froxfield Rabbits, Petersfield, Hampshlre, EngIand
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: 2.2 - 2.7 kg prior to treatment at day 1
- Housing: The rabbits were individually housed in metal cages with perforated floors.
- Diet (e.g. ad libitum): SDS Standard Rabbit diet ad libitum
- Water (e.g. ad libitum): Tap Water ad libitum
- Acclimation period: The rabbits selected for the study were all acclimated to the laboratory environment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19°C
- Humidity (%): relative humidity at 30-70%
- Air changes (per hr): approximately 19 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours of artificial light (0700-1900 hours) in each 24 hours period

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Remarks:

distilled water

Controls:

no

Amount / concentration applied:

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

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Purity: distilled water

Duration of treatment / exposure:

4 hours

Observation period:

Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4. Additional observations were made on Days 5 through 14.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm square
- % coverage:
- Type of wrap if used: 2.5 cm square gauze pad moistened with 0.5 ml distilled water occluded with "Elastoplast" elastic adhesive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed using water to remove any residual test substance
- Time after start of exposure: 4h

OBSERVATION TIME POINTS

Day 1: 30 minutes after removal of patches.
Day 2, 3 and 4
Days 5 through 14

The animals were not restrained during the exposure period and were returned to their cages.
(indicate if minutes, hours or days)

SCORING SYSTEM:
- Method of calculation: Grading and scoring of the dermal reactions were performed using the prescribed numerical scoring system as follows:

Erythema and eschar formation:

No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (neet redness) to slight eschar formation (injuries in depth) 4

Oedema formation:

No Oedema 0
Very slight Oedema (barely perceptible) 1
Slight Oedema (edges of area well-defined by definite raising) 2
Moderate Oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 1, 2, 3

Time point:

other: Days 1 - 3

Score:

4

Max. score:

4

Remarks on result:

positive indication of irritation

Remarks:

Necrosis and chemical burns

Results 2

Irritation parameter:

erythema score

Basis:

animal: 1, 2, 3

Time point:

other: Days 4 - 13

Score:

4

Max. score:

4

Remarks on result:

positive indication of irritation

Remarks:

Necrosis

Results 3

Irritation parameter:

erythema score

Basis:

animal: 1, 2, 3

Time point:

14 d

Score:

4

Max. score:

4

Remarks on result:

positive indication of irritation

Remarks:

Necrosis and scab formation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: Days 1 - 6

Score:

2

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: Days 7 - 14

Score:

1

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: Day 1 - 30 minutes after removal

Score:

3

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: Day 2 - 3

Score:

2

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: Days 4 - 14

Score:

1

Remarks on result:

positive indication of irritation

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: Days 1 - 3

Score:

2

Remarks on result:

positive indication of irritation

Results 10

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: Days 4 - 14

Score:

1

Remarks on result:

positive indication of irritation

Other effects:

Necrotic lesions and reactions resembling a chemical burn were observed in aIl three animals. The necrotic lesions persisted throughout the study. Slight or moderate oedema was present in all three animals initially and very slight oedema persisted throughout the study. Scab formation was observed around the necrotic areas in all three animals on day 14.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

A single semi-occlusive application of butyl benzotriazole, sodium salt to intact rabbit skin for four hours elicited severe persistent dermal irritation.

The results of this study established that Butyl benzotriazole, sodium salt has to be classified:
Corrosive with Risk Phase R 34: Causes burns according Directive 67/548 EEC (DSD);
Skin Corr. 1B with Hazardous statement H131: cause severe skin burns and eye damage, according regulation (EC) 1272/2008 (CLP)

Executive summary:

A study was performed to assess the skin irritation potential of COBRATEC 435 (butyl benzotriazole, sodium salt) to the rabbit

The experimental procedure used was based on that recommended under Annex V directive 79/83I/EEC. Part B: Methods for the determination of toxicity. B4. skin irritation and OECD Guideline for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion".

Three rabbits were each administred a single dermal dose of 0.5 g of the test substance and observed for 14 days

Severe persistent dermal irritation was abserved following a single semi-occlusive application of butyl benzotriazole, sodium salt to intact rabbit skin for four hours.

The results of this study established that Butyl benzotriazole, sodium salt has to be classified:

Corrosive with Risk Phase R 34: Causes burns according Directive 67/548 EEC (DSD);

Skin Corr. 1B with Hazardous statement H314: cause severe skin burns and eye damage, according regulation (EC) 1272/2008 (CLP)