Registration Dossier
Registration Dossier
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EC number: 700-680-5 | CAS number: -
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:
In a dermal sensitisation study according to OECD guideline 406 with Isostearic acid, esters with methyl α-D-glucoside in sesame oil, Dunkin-Hartley guinea pigs were tested using the method of Magnusson and Kligman. Positive control substance was 2-Mercaptobenzothiazole.
In the challenge no visible changes of the treated skin sites (no erythema and no edema) were observed at any time point.
In this study Isostearic acid, esters with methyl α-D-glucoside is not a dermal sensitizer.
Migrated from Short description of key information:
Not sensitising in the Guinea Pig Maximisation Test (OECD TG 406)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Due to the low vapour pressure of Isostearic acid, esters with methyl α-D-glucoside the absence of skin and mucosal irritation and missing indications for skin sensitisation, a respiratory sensitisation potential of the test substance can practically be excluded.
Migrated from Short description of key information:
There are no indications for a sensitising potential of Isostearic acid, esters with methyl α-D-glucoside to the respiratory tract.
Justification for classification or non-classification
Based on the results of the dermal sensitization study according to OECD guideline 406 there is no need for classification of Isostearic acid, esters with methyl α-D-glucoside according to Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008 with respect to skin sensitisation. No labelling is required.
On the basis of absence of skin and mucosal irritation, skin sensitisation and the very low vapour pressure of the test substance there is no need to classify the test substance with respect to respiratory sensitisation.
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