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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation, other
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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Skin sensitisation test in humans; following induction by repeated dermal administration of test material at the same application site, patches with test substance are placed on a virgin patch site as challenge after a rest period of two weeks.
GLP compliance:
no
Type of study:
other: repeated insult patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): diisotridecyl adipate

In vivo test system

Test animals

Species:
human
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: epicutaneous, semi-occlusive and occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
saturated patches; approx. 0.2 mL test substance was applied to each patch
Challengeopen allclose all
Route:
other: epicutaneous, semi-occlusive and occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
saturated patches; approx. 0.2 mL test substance was applied to each patch
No. of animals per dose:
104 human subjects; 19 males, 85 females; ranging in age from 18 to 65.
Test subjects were divided in 2 groups (49 and 55 subjects). One group was patched semi-occlusively, the other group was patched occlusively.
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 9
- Exposure period: 3 weeks
- Test groups: 2 (semi-occlusive and occlusive patch application)
- Control group: no
- Site: left upper back
- Frequency of applications: Mondays, Wednesdays, and Fridays over 3 weeks
- Duration: removal of patch after 24 h (observation of tests site 48 or 72 h after patch application)
- Concentrations: saturated patch (approx. 0.2 mL test substance)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: patch was removed after 24 h
- Test groups: 2 (semi-occlusive and occlusive patch application)
- Control group: no
- Site: right upper back (virgin patch site)
- Concentrations: saturated patch (approx. 0.2 mL test substance)
- Evaluation (hr after challenge): 24, 48, and 72 h after patch application

OTHER: induction period and challenge exposure were separated by a rest period of 2 weeks.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
0.2 mL
No. with + reactions:
0
Total no. in group:
104
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.2 mL. No with. + reactions: 0.0. Total no. in groups: 104.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
0.2 mL
No. with + reactions:
0
Total no. in group:
104
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.2 mL. No with. + reactions: 0.0. Total no. in groups: 104.0.

Any other information on results incl. tables

No skin reactions at all were observed neither during induction exposures nor after challenge exposure.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Diisotridecyl adipate did not induce any skin reaction in a repeated insult patch test in humans neither during induction exposure nor at challenge exposure. There was no difference between groups with semi-occlusive or occlusive patch application.
Executive summary:

The dermal sensitization potential of diisotridecyl adipate was tested with human volunteers using a repeated insult patch test. 104 human subjects (19 males and 85 females ) were divided into two groups (49 and 55 subjects) for semi-occlusive and occlusive application of test patches.

 

Induction exposure consisted of nine repeated 24 h exposures at the same site (left upper back). Test substance was administered on saturated patches (0.2 mL test substance) on Monday, Wednesday, and Friday for 3 weeks followed by a rest period of 2 weeks. After a single challenge exposure (24 h) on a virgin patch site (upper right back), the challenge reaction was evaluated 24, 48, and 72 hours after patch application.

 

No skin reaction in any of the 104 test subjects was observed either during induction exposure nor at any of the challenge readings.

 

In this study, diisotridecyl adipate did not exhibit any dermal sensitizing potential in humans (Mobil/HRL, 1987).

 

This study is classified as acceptable as it follows established procedures for a repeated insult patch test.