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Toxicological information

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Description of key information

A modified Draize-Shelanski Repeat Insult Patch Tests was carried out to test for sensitisation with the test item containing 97% active ingredient. There was no irritation or sensitisation from this material on the Draize-Shelanski Test.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study non-GLP with limited data on study design, however the study was conducted to state of the art methods at that time period. The study is therefore considered adequate, reliable and relevant.
Qualifier:
according to guideline
Guideline:
other: Modified Draize-Shelanski Repeat Insult Patch Test
GLP compliance:
no
Type of study:
other: Modified Draize-Shelanski Repeat Insult Patch Test
Justification for non-LLNA method:
The study is based on standards at the time of conduct.
Species:
human
Sex:
male/female
Details on test animals and environmental conditions:
Not applicable
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2.5% AEROSOL ® AY in petrolatum (Induction)
1% AEROSOL ® AY in petrolatum (Challenge)
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2.5% AEROSOL ® AY in petrolatum (Induction)
1% AEROSOL ® AY in petrolatum (Challenge)
No. of animals per dose:
100
Details on study design:
Modified Draize-Shelanski Repeat Insult Patch Test: Aproximately 300 mg of the test material was applied to patch sites on the back or volar forearms of 100 subjects for ten alternate-day 24 hour period under occlusion. Following a seven-day rest period, challenge patches of the material were applied in the same manner to fresh sites on the back or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5% Aerosol AY in petrolatum (induction); 1% Aerosol AY in petrolatum (challenge)
No. with + reactions:
0
Total no. in group:
100
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5% Aerosol AY in petrolatum (induction); 1% Aerosol AY in petrolatum (challenge). No with. + reactions: 0.0. Total no. in groups: 100.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5% Aerosol AY in petrolatum (induction); 1% Aerosol AY in petrolatum (challenge)
No. with + reactions:
0
Total no. in group:
100
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5% Aerosol AY in petrolatum (induction); 1% Aerosol AY in petrolatum (challenge). No with. + reactions: 0.0. Total no. in groups: 100.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Remarks on result:
not measured/tested
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
Interpretation of results:
not sensitising
Remarks:
Migrated information 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:

In a Modified Draize-Shelanski Repeat Insult Patch Test aproximately 300 mg of the test item containing > 97% active ingredient (2.5% in petrolatum) was applied to patch sites on the back or volar forearms of 100 subjects for ten alternate-day 24 hour period under occlusion. Following a seven-day rest period, challenge patches of the test item (1% in petrolatum) were applied in the same manner to fresh sites on the back 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 of 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.

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

A modified Draize-Shelanski Repeat Insult Patch Test (Kligman,1976) was carried out as a key test to investigate sensitization of the test item containing 97% active ingredient. The study design was as follows: aproximately 300 mg of the test item (2.5%) was applied to patch sites on the back or volar forearms of 100 subjects for ten alternate-day 24 hour period under occlusion. Following a seven-day rest period, challenge patches of the test item (1%) were applied in the same manner to fresh sites on the back 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 material would present a danger of irritation or sensitization in normal, intended use.

Further information supporting the absence of sensitisation potential is provided in the read across justification for the Diester category, 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).

 


Migrated from Short description of key information:
A modified Draize-Shelanski Repeat Insult Patch Test was carried out to test for sensitization with Aerosol AY (Introduction 2.5%, in petrolatum; challenge 1%, in petrolatum). There was no irritation or sensitization from this material. It is unlikely that this material would present a danger of irritation or sensitization in normal, intended use.

Justification for selection of skin sensitisation endpoint:
Key study

Justification for classification or non-classification

As there was no indication for sensitisation from the Human Patch Test with current substance and category analogues, classification for skin sensitisation is not needed according to CLP regulation (No. 1272/2008 of 16 December 2008).