Registration Dossier

Administrative data

Description of key information

Skin sensitisation non-LLNA (human closed patch test): not sensitising

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Principles of method if other than guideline:
- Principle of test:
Pre testing: The material was pre-tested on twenty-five subects in order to determine wheater sodium lauryl sulfate pre-treatment was required. A patch of the materials was applied to normal sites on the volar forearms or backs for 48 hours under occlusion.
Maximization test: The material was applied under occlusion to the same site on volar forearm or back of all subects for five alternate-day 48 hour periods. The patch site was pre-treated for 24 hours with 2.5% aqueous sodium lauryl sulfate under occlusion. The challenge site was read on removal of the patch and 24 hours thereafter.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Human data available
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: RIFM#75-8-112 Petitgrain bigarde oil
Species:
other: human
Sex:
male/female
Details on test animals and environmental conditions:
10 Male and 15 Female
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8%
Day(s)/duration:
48 hours
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
8% in petrolatum
Day(s)/duration:
48 hours
Adequacy of challenge:
not specified
No. of animals per dose:
25 humans: 10 male and 15 female
Details on study design:
The patch site was pre-treated for 24 hours with 2.5% aqueous SLS under occlusion.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
8% in petrolatum
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
8% in petrolatum
No. with + reactions:
0
Total no. in group:
25
Clinical observations:
None
Remarks on result:
no indication of skin sensitisation
Reading:
other:
Group:
negative control
Remarks on result:
not measured/tested
Reading:
other:
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
other: not classified
Remarks:
Based on CLP criteria (EC 1272/2008 and its updates)
Conclusions:
Under the conditions of this study, the test material gave no instances of irritation or contact-sensitization. Based on this result, the test substance does not need to be classified for skin irritation or sensitization in accordance with the criteria outlined in CLP (1272/2008/EC).
Executive summary:

The irritating and sensitizing potential of Petitgrain Bigarde Oil on humans was tested in a maximization test on 25 healthy adult volunteers. The test material was pretested to determine whether Sodium Lauryl Sulfate (SLS) pretreatment was required. No subject had any irritation from the test material. In the maximization test all subjects were pretreated with 2.5 % SLS (the patch sites were pretreated for 24 hours). The material was applied 8% in petrolatum under occlusion on the volar aspects of the forearm or backs for 5 alternate day-48 hour periods. The challenge site was read on removal of the patch and after 24 hours. Under the conditions of this study, the test material gave no instances of irritation or contact-sensitization. Based on this result, the test substance Petitgrain Bigarde Oil does not need to be classified for skin irritation or sensitization in accordance with the criteria outlined in CLP (1272/2008/EC).

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

Key study

The irritating and sensitizing potential of Petitgrain Bigarde Oil on humans was tested in a maximization test on 25 healthy adult volunteers (10 Male, 15 Female). The test material was pretested to determine whether Sodium Lauryl Sulfate (SLS) pretreatment was required. No subject had any irritation from the test material. In the maximization test all subjects were pretreated with 2.5 % SLS (the patch sites were pretreated for 24 hours). The material was applied under occlusion on the volar aspects of the forearm or backs for 5 alternate day-48 hour periods. The challenge site was read on removal of the patch and after 24 hours. Under the conditions of this study, the test material gave no instances of irritation or contact-sensitization. Based on this result, the test substance

Petitgrain Bigarde Oil does not need to be classified for skin irritation or sensitization in accordance with the criteria outlined in CLP (1272/2008/EC).

Supporting study

The irritating and sensitizing potential of Petitgrain Oil on human skin was tested in a closed patch test on both males and females with normal health and dermatosis. Doses were: 5% on 30 subjects with normal health, 2% on 30 subjects with normal health and 0.1% on 48 subjects with dermatosis. Under the conditions of this study, the testing material gave no instances of irritation or contact-sensitization. Based on this result, the test substance does not need to be classified for skin sensitization in accordance with the criteria outlined in CLP (1272/2008/EC).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information, Petitgrain oil citrus aurantium does not need to be classified for skin sensitization in accordance with the criteria outlined in CLP (1272/2008/EC).