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Administrative data

Description of key information

A modified Draize-Shelanski Repeat Insult Patch Tests was carried out to test for sensitization with
a test item containing 96-98% active ingredient. There was no irritation or sensitization from this
material on the Draize-Shelanski Test. It is unlikely that this material would present a danger of
irritation or sensitization in normal, intended use.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Qualifier:
according to
Guideline:
other: Modified Draize-Shelanski Repeat Insult Patch Test
Deviations:
no
Principles of method if other than guideline:
Human predictive skin sensitisation tests have been in use the last 50 years. They have been used more widely in the United States than in Europe. Sensitisation potential has been investigated, and the development of animal sensitisation tests was partly based on comparison to human tests performed with the same chemicals. Further, human testing has the advantage that extrapolation of the test results from one species to another is avoided. There are a number of different human sensitisation tests available.(http://ec.europa.eu/health/scientific_committees/consumer_safety/opinions/sccnfp_opinions_97_04/sccp_out102_en.htm)
GLP compliance:
no
Type of study:
other: Modified Draize-Shelanski Repeat Insult Patch Test
Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
Not applicable
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2.5% Induction (of Aerosol TR in petrolatum)
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1% Challenge(of Aerosol TR in petrolatum)
No. of animals per dose:
100 humans
Details on study design:
RANGE FINDING TESTS: Not provided

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 100
- Exposure period: 24 hour periods under occlusion
- Test groups: 1
- Control group: no
- Site: backs or volar forearms of 100 subjects
- Frequency of applications: 10 alternate-day
- Duration:24 h
- Concentrations: approximately 300 mg of the test material was applied of 2.5% of the test material
in petrolatum

B. CHALLENGE EXPOSURE
- No. of exposures: 100
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: 100 humans
- Control group: no
- Site: fresh sites on the backs or volar forearms of 100 subjects
- Concentrations: 1% of the test material in petrolatum
- Evaluation (hr after challenge):24 and 48 hours
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
300 mg
No. with + reactions:
0
Total no. in group:
100
Clinical observations:
none
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
300 mg
No. with + reactions:
0
Total no. in group:
100
Clinical observations:
none
Interpretation of results:
not sensitising
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
There were no instances of irritation or sensitization from this test item on the Draize-Shelanski Test.
It is unlikely that this test item would present a danger of irritation or sensitization in normal, intended use.
Executive summary:

Approximately 300 mg of the test item, containing 96 -98% active ingredient (2.5% in petrolatum) was applied to patch sites on the backs or volar forearms of 100 subjects for ten alternate-day 24 hour periods under occlusion. Following a seven-day rest period, challenge patches of the test item (1.0% in petrolatum) were applied in the same manner to fresh sites on the backs or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter.There were no instances of irritation or sensitization from this material on the Draize-Shelanski Test. It is unlikely that this test item would present a danger of irritation or sensitization in normal, intended use.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Human Patch Testing

A modified Draize-Shelanski Repeat Insult Patch Test was carried out to test for sensitisation with a test item containing 96 -98% active ingredient (Kligman, 1976). The study design was as follows: approximately 300 mg of the test item (2.5% in petrolatum) was applied to patch sites on the backs or volar forearms of 100 subjects for ten alternate-day 24 hour periods under occlusion. Following a seven-day rest period, challenge patches of the test item (1.0% in petrolatum) were applied in the same manner to fresh sites on the backs or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter. There were no instances of irritation or sensitisation from this material on the Draize-Shelanski Test. It is unlikely that this material would present a danger of irritation or sensitisation in normal, intended use.

 

Further information supporting the absence of sensitisation potential is provided in the read across justification for the Diester subgroup, showing that all substances in the group were negative for human patch testing on the human arm skin (justification with data matrix separately attached in Section 13).

Justification for selection of skin sensitisation endpoint: Key study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

As there was no indication for sensitisation from the human patch test with current test item and category analogues, classification for skin sensitisation is not needed according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008).