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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:
1975
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
no
Type of study:
Freund's complete adjuvant test
Justification for non-LLNA method:
At the time of the study, it didn't use to perform LLNA method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
additive
Test material form:
liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
paraffin oil
Concentration / amount:
10% of esterification products of alcohols C12-13 linear and branched with lauric acid, 90% paraffin oil
Day(s)/duration:
Day 0 / intradermal injections
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Route:
other: washing with 10% SDS solution
Vehicle:
paraffin oil
Concentration / amount:
10% SDS; 90% paraffin oil
Day(s)/duration:
Day 7: duration 24h
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
50% esterification products of alcohols C12-13 linear and branched with lauric acid, 50% paraffin oil
Day(s)/duration:
Days 8 and 9 / duration 48h
Adequacy of induction:
non-irritant substance, but skin pre-treated with 10% SDS
Challenge
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
10% esterification products of alcohols C12-13 linear and branched with lauric acid, 90% paraffin oil
Day(s)/duration:
Day 22 / duration 24h
Adequacy of challenge:
other: non-irritant substance
No. of animals per dose:
30 (20 tested animals, 10 control animals)
Challenge controls:
10 Guinea pigs
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10% of esterification products of alcohols C12-13 linear and branched with lauric acid in paraffin oil
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10% of esterification products of alcohols C12-13 linear and branched with lauric acid in paraffin oil
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
100% paraffin oil
No. with + reactions:
2
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
100% paraffin oil
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Executive summary:

There were no mortalities. There was no treatment related alteration of body weight increase. Any consistent evidence of treatment related skin irritation was absent. Any evidence of skin reaction attributable to a sensitizing activity of esterification product of alcohols C12-13 linear and branched with lauric acid was absent.

In conclusion the result of this assay indicates that, in our experimental conditions, esterification product of alcohols C12-13 linear and branched with lauric acid is devoid of sensitizing activity in Guinea pig.