Registration Dossier

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 GLP-compliant guinea pig maximisation test performed according to OECD 406, the skin sensitisation potential of 1,2,3-propanetriyl triisooctadecanoate was studied (Jones, 1987). Based on the results of range finding tests, concentrations of 25 and 100% were selected for intradermal and epicutaneous treatment, respectively. In the induction phase of the main study, intradermal injections of the test substance at 25% in arachis oil and/or FCA were applied into the clipped dorsal area of 20 females. A control group, consisting of 10 females, was injected with vehicle only and/or FCA. On Day 8, a 48-hour epicutaneous induction treatment with test substance at 100% or sham-exposure with a blank filter paper was performed in the treated or control animals on the regions of intradermal injections. On Day 22, the challenge treatment was performed by topical application of the test substance at 100% (right flank) and a blank patch (left flank) to all animals for 24 h. Skin reactions were evaluated 24 and 48 h after the challenge application. During the study, no test substance-related clinical signs and no effects on body weight gain were observed. No cutaneous reactions were observed after challenge treatment with the test substance at 100% in any of the animals of the test and control groups. Formaldehyde in 40% w/v aqueous solution, which served as historical positive control, showed the expected results (> 30% positive response in the animals) and thus verified the reliability of the assay. Based on the results, the test substance had no sensitising effect in guinea pigs under the experimental conditions.

In a publication by Tanabe (1999), glycerol triisostearate was used as a reference substance during patch testing of a subject with allergic contact dermatitis caused by a lipstick (see section 7.10.4). A 23-yr old woman presented with persistent erythema on the lips and a rash extending to the neck (allergic contact dermatitis) that had lasted for 2 months. Patch testing was performed initially with cosmetic products suspected to have caused the skin reaction. Subsequently, patch testing was performed using the individual ingredients of a lipstick that caused a positive skin reaction. The ingredient(s) provoking renewed positive skin reaction could then be identified as the cause of the allergic contact dermatitis. The testing was performed by applying an occlusive patch with the substance to the skin for an unknown amount of time, and scoring the skin reaction after 48 and 72 h hours according to the criteria of the International Contact Dermatitis Research Group. As a mixture of glyceryl mono-, di- and tri-isostearate was used in the cosmetic, both the mixture and the isolated mono-, di- and tri-isostearates were tested separately. Glycerol monoisostearate provoked a strong positive skin reaction at concentrations ≥ 0.01% dilution in petrolatum (pet) at both reading time points, while the result for glycerol diisostearate was negative. For glycerol triisostearate, results were negative for the concentration range 0.1 – 30% pet. The test substance was therefore considered not to cause skin sensitisation in the test subject. 

Overall conclusion for skin sensitisation

No skin sensitising potential was observed in the animal study and the human patch test performed with 1,2,3-propanetriyl triisooctadecanoate.


Migrated from Short description of key information:
Skin sensitisation (GPMT): not sensitising

Justification for selection of skin sensitisation endpoint:
The selected study is the most adequate and reliable study based on overall quality assessment (refer to endpoint discussion for further details).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation do not meet the classification criteria according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.