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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
1 (reliable without restriction)
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:
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
This is formulation of 49.2% of the test substance in water.
Specific details on test material used for the study:
- ca. 50% Cocobenzyldimethylammonium chloride (CAS no.: 61789-71-7) in water.
- Arquad B-50 is based on full coco.
- Chainlength distribution of full coco: C8: 5%; C10: 6%; C12: 50%; C14: 19%; C16: 10%; C18:10%.

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
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Details:
After 3’: Well-defined erythema with moderate oedema at 72h; 
After 30’: Severe erythema (necrotic reaction) with slight oedema;
After 60’: 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’, and another 3 rabbits for 60’. 
Effects at 3’: no dermal reactions at any of the six sites.
Effects at 60’: 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

Conclusions:
Under the study conditions, there was evidence of skin necrosis when the test substance was applied under occlusion to intact rabbit skin for a period of 60 minutes. No visible evidence of necrosis was seen after a 3 minute application. As all products from the individual chain lengths between C8 and C18 are corrosive, the results from this test substance with a full coco distribution are representative for the spectrum of commonly used test substance products. Under the conditions of the study, the test substance was corrosive to rabbit skin and requires a classification of Category 1B: Corrosive, according to the EU CLP.
Executive summary:

A study was conducted to determine the skin irritation / corrosion potential of the test substance 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 50% solution of test substance 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 with slight oedema 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).