Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November / December 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Dose levels
GLP compliance:
not specified
Type of study:
open epicutaneous test
Justification for non-LLNA method:
Study was performed in 1980, this led to a deviation of the preferred LLNA test.
Test material information:
Composition 1
Species:
guinea pig
Sex:
not specified
Details on test animals and environmental conditions:
Housing and feeding conditions:
The temperature of the experimental animal room was 20°C. The relative humidity was 50%. Lighting was artificial, the sequence was 12 hours light, 12 hours dark. Food and water was provided at discretion.
Route:
epicutaneous, open
Vehicle:
other: vaseline
Concentration / amount:
200 ppm
Day(s)/duration:
21 d
No.:
#1
Route:
epicutaneous, open
Vehicle:
other: vaseline
Concentration / amount:
200 ppm
Day(s)/duration:
1
No.:
#2
Route:
epicutaneous, open
Vehicle:
other: vaseline
Concentration / amount:
200 ppm
Day(s)/duration:
2
No.:
#3
Route:
epicutaneous, open
Vehicle:
other: vaseline
Concentration / amount:
200 ppm
Day(s)/duration:
3
No. of animals per dose:
12
Details on study design:
After the induction period and before the challenges, a break of five days was performed.
Challenge controls:
After 24 h, 2 and 3 days
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
200 ppm
Total no. in group:
12
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
200 ppm
Total no. in group:
12
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
other: 3rd reading
Hours after challenge:
72
Group:
test group
Dose level:
200 ppm
Total no. in group:
12
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
During the induction period, the test substance 2-lauroyloxyethyltrimethylammonium chloride in vaseline was applied daily on shaved skin (right flank). After this induction period of 3 weeks and a five-day break a challenge was performed daily for three days on shaved skin (left flank). Controls were done after 24, 48 and 72 h. At no time, a reaction could be observed in the control area. The test substance can be stated as non-sensitizing.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

A study was performed to determine the sensitizing property of the test substance 2-lauroyloxyethyltrimethylammonium chloride. In the above mentioned open epicutaneous test no skin reactions were observed whereby the test substance can be stated as non-sensitizing.