Registration Dossier

Toxicological information

Sensitisation data (human)

Currently viewing:

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
Not reported
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary literature source (documentation insufficient for assessment).
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
review article or handbook
Title:
Final Report on the Safety Assessment of Ricinus Communis (Castor) Seed Oil, Hydrogenated Castor Oil, Glyceryl Ricinoleate, Glyceryl Ricinoleate SE, Ricinoleic Acid, Potassium Ricinoleate, Sodium Ricinoleate, Zinc Ricinoleate, Cetyl Ricinoleate, Ethyl Ric
Author:
Cosmetic Ingredient Review (CIR) Panel
Year:
2007
Bibliographic source:
Int. J. Toxicol. 26(3):31–77

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Principles of method if other than guideline:
A patch test, with 30% hydrogenated castor oil, was conducted on one to twenty patients (age not stated) either suffering from or suspected of suffering from contact allergy to cosmetic products, to evaluate if the test material is sensitizing to human.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hydrogenated castor oil

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
No data
Clinical history:
- History of allergy or casuistics for study subject or populations: either suffering from or suspected of suffering from contact allergy to cosmetic products
Controls:
Not applicable
Route of administration:
dermal
Details on study design:
ADMINISTRATION
- Vehicle / solvent: petrolatum
- Concentrations: 30%

Results and discussion

Results of examinations:
RESULT OF CASE REPORT: no reactions to 30% hydrogenated castor oil

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
The patch test result indicated that 30% test substance did not induce contact allergy in human.
Executive summary:

A patch test, with 30% hydrogenated castor oil, was conducted on one to twenty patients (age not stated) either suffering from or suspected of suffering from contact allergy to cosmetic products, to evaluate if the test material is sensitizing to human.

The patch test result indicated that 30% test substance does not induce contact allergy in human.