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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:
23 October 1979 to 28 November 1979
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:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Principles of method if other than guideline:
Hartley Albino guinea pigs, approx 5 weeks old were acclimatized for one week in the laboratory. 10 were selected for dosing. The animals were identified by cage tags noting hte test material, starting date, animal number and sex.
GLP compliance:
no
Type of study:
Draize test
Justification for non-LLNA method:
Conducted prior to LLNA test introduced

Test material

Constituent 1
Chemical structure
Reference substance name:
2-ethylhexyl 12-hydroxyoctadecanoate
EC Number:
249-793-7
EC Name:
2-ethylhexyl 12-hydroxyoctadecanoate
Cas Number:
29710-25-6
Molecular formula:
C26H52O3
IUPAC Name:
2-ethylhexyl 12-hydroxyoctadecanoate
Test material form:
other: oil
Details on test material:
a-ethyl-hexyl-oxystearate
Specific details on test material used for the study:
Wickenol 171, 2ethylhexyl oxystearate, Lot #424-9

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
Hartley Albino rats approximatley 5 weeks old were received and equilibrated for at least a week in the laboratory. 10 healthy animals were selected for testing.

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.05 ml initially then 0.1ml for subsequent injections
Day(s)/duration:
3 consecutive days/week for 3 weeks
Adequacy of induction:
not specified
Challengeopen allclose all
No.:
#1
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1ml
Day(s)/duration:
first day of the series in the fourth week
Adequacy of challenge:
not specified
No.:
#2
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1ml
Day(s)/duration:
second day of the series
Adequacy of challenge:
not specified
No.:
#3
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1ml
Adequacy of challenge:
not specified
No.:
#5
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1ml
Adequacy of challenge:
not specified
No.:
#7
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1ml
Adequacy of challenge:
not specified
No.:
#4
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1ml
Adequacy of challenge:
not specified
No.:
#6
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1ml
Adequacy of challenge:
not specified
No.:
#8
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1ml
Adequacy of challenge:
not specified
No.:
#9
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1
Adequacy of challenge:
not specified
No.:
#10
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
0.1ml
Adequacy of challenge:
not specified
No. of animals per dose:
10
Details on study design:
The test material was injected intradermally
Challenge controls:
No
Positive control substance(s):
no

Results and discussion

Positive control results:
N/A

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.05
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation

Any other information on results incl. tables

Treatment Number Erythema   Edema
 1  0.4  0
 2  0.5  0.1
 3  0.4  0.1
 4  0.5  0.2
 5  0.4  0
 6  0.5  0.2
 7  0.8  0.5
 8 0.5 0.5 
 9  1.3  0.9
 10  1.9  1.1
 average  0.71  0.36

challenge                                                                                                         0.66                                                                                                  0

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
Under the conditions of the test, the material does not appear to be a sensitizer.
Executive summary:

10 Hartley albino rats were injection intradermally for 3 consecutive days/week for three weeks. 14 days after the last induction exposure, the animals were challenged in the same manner at a site removed from the sites of the induction treatment.

There was no evidence of a significant increase in these scores to indicate that the test material is a sensitiser.