Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
other: Maurer optimisation test
GLP compliance:
not specified
Type of study:
Maurer optimisation test

Test material

Constituent 1
Reference substance name:
Ascorbic acid
EC Number:
200-066-2
EC Name:
Ascorbic acid
Cas Number:
50-81-7
IUPAC Name:
5-(1,2-dihydroxyethyl)-3,4-dihydroxyfuran-2(5H)-one (non-preferred name)
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