Benzethonium chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jaunary 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

Principles of method if other than guideline:

DOT Skin Corrosion, Department of Transportation CFR Title 49, 173, 1200

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzethonium chloride

EC Number:

204-479-9

EC Name:

Benzethonium chloride

Cas Number:

121-54-0

Molecular formula:

C27H42NO2.Cl

IUPAC Name:

benzyldimethyl(2-{2-[4-(2,4,4-trimethylpentan-2-yl)phenoxy]ethoxy}ethyl)azanium chloride

Test material form:

solid: compact

Specific details on test material used for the study:

- Source and lot/batch No.of test material: Lonza Inc., Fair Lawn, New Jersey
- product name: HYAMINE 1622 Powder (K-11-16)
- description: white powder
- Expiration date of the lot/batch: no data
- Purity test date: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Albino Rabbits from Davidson's Mill Farm, USA
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: animals were individually housed in stainless steel wire bottomed cages
- Diet (e.g. ad libitum): Purina Rabbit Pellets
- Water (e.g. ad libitum): water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

0.78 grams of test material was uniformly mixed with deionized distilled water and applied as a 63.7% suspension (w/w) to give 0.5 grams of material per site

Duration of treatment / exposure:

4 hours

Observation period:

Reading 4 and 48 hours as well as 5 and 8 days after exposure

Number of animals:

6 animals

Details on study design:

A 2.5 cm2 gauze patch was placed over intact skin on each rabbit. Five-tenths of a gram of the testmaterial was placed under each patch. The patches were secured in place with adhesive tape. The entire trunk of each animal was wrapped with a rubberized elastic cloth to retard evaporation and as an aid in maintaining test patch position. The rabbits were then immobilized in head stocks for 4 hours after which time the patches were removed. All test sites were washed to prevent further exposure. Corrosion readings were made at 4 and 48 hours after exposure. Corrosion was considered to have resulted if the test substance caused destruction or irreversible alteration of the tissue. Tissue destruction was considered to have occurred if, at any of the readings, there was ulceration or necrosis. Epidermal sloughing, erythema, edema or fissuring were not considered tissue destruction.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other:

Basis:

mean

Time point:

other: 4 h

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

other:

Basis:

mean

Time point:

48 h

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

other:

Basis:

mean

Time point:

other: 8 d

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

At 4 hours the test site was brownish in color. Thickening of the test site with reduced flexibility was alsp noted. There was no evidence of necrosis, ulceration or sloughing. At 48 hours one rabbit exhibited necrosis. The test sites on the other rabbits remained brown (slightly darker than at 4 hours) and thickened, with reduced flexibility. At 8 days the rabbits exhibited necrosis, however, there were no signs of ulceration or sloughing. In conclusion, the test item needs to be considered as corrosive to rabbit skin.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Based on the 4 and 48 hour scores, the test material is considered to be corrosive to the skin.

Executive summary:

Skin corrosion was tested in accordance with DOT Skin Corrosion, Department of Transportation CFR Title 49, 173, 1200. Six NZW rabbits were treated occlusive with 0.78 g of test item mixed with deionized water for 4 hours. Skin reactions were assessed 4 hours, 48 hours and 8 days after removal of the patch. At 4 hours the test site was brownish in color. Thickening of the test site with reduced flexibility was alsp noted. There was no evidence of necrosis, ulceration or sloughing. At 48 hours one rabbit exhibited necrosis. The test sites on the other rabbits remained brown (slightly darker than at 4 hours) and thickened, with reduced flexibility. At 8 days the rabbits exhibited necrosis, however, there were no signs of ulceration or sloughing. Based on the 4 and 48 hour scores, the test material is considered to be corrosive to the skin.