Registration Dossier
Registration Dossier
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EC number: 294-601-7 | CAS number: 91744-39-7
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The sensitizing potential of the test substance (CAS 91744-39 -7, Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts) was investigated in a study according to OECD Guideline No. 406 "Skin Sensitization (maximization test)”.Concentrations used for intradermal and dermal induction were 5 % in water and 50 % in vaseline, respectively. Since the 50 % test substance formulation was non-irritating after dermal application in the range finding test, the skin area was pretreated with 10 % sodium lauryl sulfate in vaseline 24 h before dermal induction treatment to induce a mild inflammation. Challenge exposure concentration was 50 % in vaseline.
No allergic skin reactions occurred in test or control animals 24 and 48 h after the end of the challenge procedure. The sensitisation rate was 0 %.
In this study,the test substance is not a dermal sensitizer.
This result is supported by a second study in which the sensitizing potential of the analogue substance CAS 91744-23-9 was investigated in an OECD 406 study. The substance concentrations for induction were 5 % (intradermal induction) and 25 % (topical induction). Substance concentrations for induction and challenge were 2, 25, 50, and 100 % in corn oil
Animal sites were graded according to the Magnusson and Kligman grading scale for the evaluation of challenge patch test reactions. No animals of the test or control groups produced reactions at either the test or vehicle control sites, at the 24 or 48 h readings.
Migrated from Short description of key information:
A key study (Harlan, 2001) as well as a supporting study (Kruger, 1996) are available. Both studies were conducted according to OECD 406. In both studies no animals of the test or control groups produced reactions.
Justification for selection of skin sensitisation endpoint:
Key study for sensitization endpoint. Study was conducted according to OECD 406 under GLP.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No sensitizing effect was observed at appropriate dose levels.
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