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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
ca. 50% Cocobenzyldimethylammonium chloride (CAS no.: 61789-71-7) in water.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Vehicle:
water
Amount / concentration applied:
Concentration: 50 % active substance
Duration of treatment / exposure:
4 h
Observation period:
24, 48 and 72 h
Number of animals:
1 in pre-test; 3 in confirmatory test

Results and discussion

In vivo

Results
Remarks on result:
other: 50% active substance was corrosive to the skin

Any other information on results incl. tables

after 3’: well-defined erythema with moderate oedema at 72 h; 
30’: Severe erythema (necrotic reaction) with slight oedema;
60’: Moderate to severe erythema with moderate oedema at 72 h;
4 h: Severe erythema (necrotic reaction) with severe oedema. Primary Irritation Index: 7.0

Confirmatory 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. Results 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

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There was evidence of skin necrosis when 50% active 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. Under the conditions of the study, the 50% active test substance was corrosive to the skin and requires a classification of Category 1B: Corrosive, according to the EU CLP.
Executive summary:

In a guideline study, skin irritation test, 0.5 mL of a 50% solution of C12-16 ADBAC was applied under occlusive dressing to the skin of 1 rabbit for 3, 30, 60 minutes and 4 hours. The skin was washed with water upon removal of the dressing. Observations were recorded at 24, 48 and 72 hours. A confirmatory study was performed with 3 or 60 minute applications in 3 rabbits each. In the confirmatory study, no dermal reactions were observed at any of the six sites up on 3 minute application. Moderate erythema with slight oedema at 4 sites and areas of skin necrosis at the other two sites were observed following 1 hour application (Primary irritation index PII: 3 minute: 0; 60 minute: 4.5). There was evidence of skin necrosis when 50% active 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. Under the conditions of the study, the 50% active test substance was corrosive to the skin (Liggett MP and Seaber JA, 1982).