Quaternary ammonium compounds, benzyl C12-C16 (even numbered)-alkyldimethyl chlorides

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Transport of dangerous goods, special recommendations relating to Class 8, United Nations handbook, 1977.

Deviations:

no

GLP compliance:

no

Remarks:

Study performed before GLP

Test material

Test material information

Constituent 1

Reference substance name:

N-benzyl-N,N-dimethyltetradecan-1-aminium chloride

EC Number:

939-253-5

Cas Number:

68424-85-1

Molecular formula:

C12-14H25-29-(CH3)2-C6H5-N.Cl

IUPAC Name:

N-benzyl-N,N-dimethyltetradecan-1-aminium chloride

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

Concentration: 50 % active substance

Duration of treatment / exposure:

4h

Observation period:

24, 48 and 72h

Number of animals:

1 in pre-test; 3 in main test

Details on study design:

- An amount of 0.5 mL of undiluted test substance (50% a.i.) was applied under occluded dressing onto the skin of 1 rabbit for 3’, 30’, 60’, and 4h. The skin was washed with water upon removal. 
- Observations: 24, 48 and 72h.
- A confirmatory study was performed at 3 min and 60 min applications in 3 rabbits each.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

60 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 2.6

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: skin corrosive

Results 2

Irritation parameter:

erythema score

Remarks:

3 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Results 3

Irritation parameter:

edema score

Remarks:

60 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 1.9

Max. score:

4

Reversibility:

not specified

Remarks on result:

other: skin corrosive

Results 4

Irritation parameter:

edema score

Remarks:

3 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Reversibility:

not specified

Irritant / corrosive response data:

Details:
After 3 min: Well-defined erythema with moderate oedema at 72h; 
After 30 min: Severe erythema (necrotic reaction) with slight oedema;
After 60 min: Moderate to severe erythema with moderate oedema at 72h;
After 4h: Severe erythema (necrotic reaction) with severe oedema. 
Primary Irritation Index: 7.0
- Main study in 3 rabbits, 2 sites each with exposure for 3 min, and another 3 rabbits for 60 min. 
Effects at 3 min: no dermal reactions at any of the six sites.
Effects at 60 min: Moderate erythema with slight oedema at 4 sites and areas of skin necrosis at the other two sites.
Primary irritation index PII: 3 min: 0; 60 min: 4.5
50% active substance was corrosive to the skin

Applicant's summary and conclusion

Interpretation of results:

other: Category 1B (Corrosive) based on CLP criteria

Conclusions:

Under the conditions of the study, the test substance solution was considered to be corrosive to rabbit skin.

Executive summary:

A study was conducted to determine the skin irritation / corrosion potential of the test substance, C12-16 ADBAC (50% active in water) according to the method 'Transport of dangerous goods, special recommendations relating to Class 8, United Nations handbook, 1977'. In this experiment, 0.5 mL of a the undiluted test substance (50% active) was applied under occlusive dressing to the skin of 1 rabbit for 3, 30, 60 min and 4 h. The skin was washed with water upon removal of the dressing. Observations were recorded at 24, 48 and 72 h. A confirmatory study was performed with 3 min or 1 h applications in 3 rabbits each. In the main study, no dermal reactions were observed at any of the 6 sites after 3 min application. Moderate erythema (mean score: 2.6) with slight oedema (mean score: 1.9) at 4 sites and areas of skin necrosis at the other 2 sites were observed following 1 h application (Primary irritation index PII: 3 min: 0; 60 min: 4.5). Under the conditions of the study, the test substance solution was considered to be corrosive to rabbit skin (Liggit, 1982).