Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles - preGLP

Data source

Reference
Reference Type:
publication
Title:
The sensitization potential of some perfume ingredients tested using a modified Draize procedure
Author:
D.W. Sharp
Year:
1978
Bibliographic source:
Toxicology, 9: 267-271

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
the equivalent total dose was administered on one occasion as 4 intradermal injections, each 2.5 times the initial challenge concentration
GLP compliance:
not specified
Type of study:
Draize test
Justification for non-LLNA method:
The LLNA method was not available at the time the study was conducted. An appropriate and adequate Draize test was conducted and is available. Therefore the endpoint was adequately assessed and from an animal welfare standpoint conducting an additional LLNA is not necessary.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
No data provided

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
Housed in wire cages in pairs of the same sex and were fed pelleted guinea pig diet, cabbage, hay, and water ad libitum. Ten animals weighing about 350 g at the start of the testing were used in each test.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Injection challenge concentration
Application challenge concentration
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Injection challenge concentration
Application challenge concentration
No. of animals per dose:
4 males, 6 females
Details on study design:
Animals were induced by 4 intradermal injections of test material given. For each animal 0.1 ml aliquots of test substance 2.5 times the ICC were injected intradermal at 4 sites which overlie the 2 axillary and 2 inguinal lymph nodes. Fourteen days later each animal was challenged intradermal in one flank and topically in the other with 0.1 ml aliquots of test substance at the respective ICC and ACC: the topical application was made by spreading 0.1 ml of the test substance onto the shaved flank in a small circular area which was not covered. Twenty-four hours later the reactions were scored and apparent sensitization reactions confirmed 7 days later by a second challenge with control induced. In the absence of sensitization reactions at first challenge the induction and challenge procedures were repeated, but this time a confirmatory challenge with controls was included irrespective of any apparent sensitization reactions at the previous challenge.
Challenge controls:
At each challenge with controls, 4 previously untreated animals of the same sex and similar weight to the test animals were treated intradermally and topically on opposite flanks with 0.1 ml aliquots of control material.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Group:
test group
Dose level:
0.1 ml
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 0.1 ml. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other:
Group:
positive control
Dose level:
N/A; no positive control utilized in this study
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
not measured/tested
Reading:
other:
Group:
negative control
Dose level:
N/A; no solvent control information provided
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Conclusions:
The skin sensitization potential of isodecanol is negative.
Executive summary:

Isodecanol was administered in a modified Draize test to 10 male and female guinea pigs.  Following a preliminary irritation test, 10 Hartley guinea pigs were treated by intradermal injection (0.01 ml) to induce sensitization and challenged two weeks later by both intradermal injection and topical application (0.01 ml). No indication of sensitization was noted.