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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
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

Constituent 1
Chemical structure
Reference substance name:
2-lauroyloxyethyltrimethylammonium chloride
EC Number:
246-745-7
EC Name:
2-lauroyloxyethyltrimethylammonium chloride
Cas Number:
25234-60-0
Molecular formula:
C17H36NO2.Cl
IUPAC Name:
[2-(dodecanoyloxy)ethyl]trimethylazanium chloride

In vivo test system

Test animals

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.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, open
Vehicle:
other: vaseline
Concentration / amount:
200 ppm
Day(s)/duration:
21 d
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
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 chemical
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 chemical
Dose level:
200 ppm
Total no. in group:
12
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

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.