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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: 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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
CAS #
For specific details on test material if available - See in RSS
Name of test material (as cited in study report or in reference): Petitgarin oil, Petitgrain oil (Paraguay), Petitgrain oil (Bigarade) and Petitgrain oil (Terpeneless)
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

Test animals

Species:
other: human

Test system

Type of coverage:
occlusive
Vehicle:
other: petrolatum
Amount / concentration applied:
TEST MATERIAL
- Concentration: 8% in petrolatum
Duration of treatment / exposure:
48 hours
Observation period:
24 hours
Number of animals:
25 humans: 10 male and 15 female

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
other: 25 humans 18+
Remarks:
Dose 8% in petrolatum
Time point:
48 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
overall irritation score
Basis:
other: 25 humans 18+
Remarks:
Dose 8% in petrolatum
Time point:
72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
none
Other effects:
none

Applicant's summary and conclusion

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 testing material gave no instances of irritation. Based on this result, the test substance does not need to be classified for skin irritation in accordance with the criteria outlined in CLP (1272/2008/EC).
Executive summary:

The skin irritating potential of Petitgrain Bigarde Oil on humans was tested on 25 healthy adult volunteers. The material was applied under occlusion on the volar aspects of the forearm or backs for 48 hours. No subject had any irritation from the testing material. Under the conditions of this study, the testing material gave no instances of irritation. Based on this result, the test substance does not need to be classified for skin irritation in accordance with the criteria outlined in CLP (1272/2008/EC).