Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
Final Report on the Safety Assessment of Ascorbyl Palmitate, Ascorbyl Dipalmitate, Ascorbyl Stearate,Erythorbic Acid, and sodium Erythorbate
Author:
F. Alan Andersen
Year:
1999
Bibliographic source:
International Journal of Toxicology

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: Maurer optimisation test
GLP compliance:
not specified
Type of study:
Maurer optimisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

In vivo test system

Test animals

Species:
guinea pig
Sex:
female

Results and discussion

Any other information on results incl. tables

In a Maurer optimization test on female guinea pigs, after intradermal injection with and without Freund's Complete Adjuvant, no evidence was observed of sensitization by intradermal injection of 0.1ml of a 0.1% physiological saline, or by occluded epicutaneous application of 0.05ml/cm2 of 1 10% dispersion in petroleum ether.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU