Registration Dossier

No studies are available for the substance Reaction product of saturated palm kernel fatty acids and oxybispropanediol. Data were therefore obtained for the group of polyglyceryl fatty acid esters (mono and multi-esters).

Polyglycerol esters have been evaluated by CIR in a Safety Assessment of Polyglyceryl Fatty Acid Esters as Used in Cosmetics (CIR 2016). Seven studies investigated the skin sensitisation potential of polyglyceryl monoesters in guinea pigs and one study used the mouse. Four studies were performed according to the OECD 406 guideline, one according to the OECD 429 (LLNA, mouse study), one as GPMT and the last was a preliminary test study. Exposure concentrations were only reported for the two non-OECD guideline studies and were between 12.5% and 100% for topical induction and challenge. All the studies reported the test substance as not sensitizing (CIR 2016).

Furthermore, 14 studies investigated the skin sensitisation potential of polyglyceryl multi-esters (i.e., not mono-esters and not “polyesters”). Of these one was performed according to the OECD 406 guideline, one as Buehler test, four studies as GPMT, the remaining eight studies was either preliminary studies or no guideline was specified. Out of 14 studies 11 studies found no skin sensitizing effects of the test substance. One study reported that the results were inconclusive, in two preliminary studies positive reactions for skin sensitisation were observed after 24h and 48h and resolved 24h after exposure. the two preliminary studies used only two guinea pigs and a study protocol not in compliance with the recemented OECD test guidelines for skin sensitisation (CIR 2016).

Four human clinical studies were reported in CIR 2016. One study investigated the skin sensitisation potential of polyglyceryl monoesters using 114 subjects exposed to a 100%, 150μl test patch, HRIPT. The test substance did not cause skin sensitisation. Three studies used polyglyceryl multi-esters for studying the skin sensitisation potential. The first was identical in relation to test procedure (103 subjects exposed to a 100%, 150μl test patch, HRIPT) to that using polyglyceryl monoesters. The two others used 50 and 51 subjects 100%, 25μl occlusive patches. Induction 48-h, 3 x week for 3 weeks and challenge 48h following a 2-week non-treatment period. Both studies found polyglyceryl multi-esters to be non-sensitising (CIR 2016).

Based on the animal and human clinical studies available for the group of polyglycerol fatty acid esters, which all showed that dermal exposure to polyglycerol mono- and multi-esters did not cause skin sensitisation, it can with a high degree of confidence be concluded that the same can also be assumed for Reaction product of saturated palm kernel fatty acids and oxybispropanediol. Thus, Reaction product of saturated palm kernel fatty acids and oxybispropanediol is not to be classified as a skin sensitizer.

Reference

Endpoint:

skin sensitisation, other

Type of information:

other: weight of evidence analysis based on expert evaluated data on hydrolysis products and structural analogues

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: based on expert group reviews

Justification for type of information:

No studies are available for Reaction product of saturated palm kernel fatty acids and oxybispropanediol. Data were therefore obtained for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and structural analogues.

Reaction product of saturated palm kernel fatty acids and oxybispropanediol is an UVCB substance, manufactured by a reaction between saturated palm kernel oil fatty acids with diglycerol. The UVCB substance belongs to the group of polyglyceryl fatty acid esters, which are commonly used in cosmetics and as food ingredients.

In order to assess the skin sensitisation of the substance, the toxicity of polyglyceryl fatty acid esters in general is therefore considered. As polyglycerol contains of diglycerols together with triglycerols and tetraglycerols, and as information on metabolism in vivo and in vitro is available, read-across to data on these substances is considered acceptable for the present substance.

In general, data from the following expert assessments evaluating polyglyceryl fatty acids esters are used in a weight of evidence approach:

CIR. Safety Assessment of Polyglyceryl Fatty Acid Esters as Used in Cosmetics, Final report, November 14, 2016

Principles of method if other than guideline:

The results are based on a weight of evidence analysis from collection of studies extracted from the literature. For more details please refer to the attached weight of evidence document.

Reaction product of saturated palm kernel fatty acids and oxybispropanediol is an UVCB substance, manufactured by a reaction between saturated palm kernel oil fatty acids with diglycerol. The UVCB substance belongs to the group of polyglyceryl fatty acid esters, which are commonly used in cosmetics and as food ingredients.

In order to assess the skin sensitisation, the toxicity of polyglyceryl fatty acid esters in general is therefore considered.

As polyglycerol contains of diglycerols together with triglycerols and tetraglycerols, and as information on metabolism in vivo and in vitro is available, read-across to data on these substances is considered acceptable for the present substance. In general, data on polyglycerol esters of fatty acids, mono- and diglycerides of fatty acids, glycerol/diglycerol and fatty acids will be used.

Type of study:

other: weight of evidence analysis based on expert evaluated data on hydrolysis products and structural analogues using in vivo/in vitro data

Remarks on result:

other: Based on the studies available for the group of polyglycerol fatty acid esters, the relevant hydrolysis products and the components of the UVCB substance, it is concluded that the substance is not a skin sensitiser.

Remarks on result:

other: Based on the studies available for the group of polyglycerol fatty acid esters, the relevant hydrolysis products and the components of the UVCB substance, it is concluded that the substance is not a skin sensitiser.

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the animal and human clinical studies available for the group of polyglycerol fatty acid esters, which all showed that dermal exposure to polyglycerol mono- and multi-esters did not cause skin sensitation, it can with a high degree of confidence be concluded that the same can also be assumed for Reaction product of saturated palm kernel fatty acids and oxybispropanediol. Thus, Reaction product of saturated palm kernel fatty acids and oxybispropanediol is not to be classified as a skin sensitizer.

Executive summary:

No studies are available for the substance "Reaction product of saturated palm kernel fatty acids and oxybispropanediol". Data were therefore obtained for the group of polyglyceryl fatty acid esters (mono and multi-esters).

Polyglycerol esters have been evaluated by CIR in a Safety Assessment of Polyglyceryl Fatty Acid Esters as Used in Cosmetics (CIR 2016). Seven studies investigated the skin sensitisation potential of polyglyceryl monoesters in guinea pigs and one study used the mouse. Four studies were performed according to the OECD 406 guideline, one according to the OECD 429 (LLNA, mouse study), one as GPMT and the last was a preliminary test study. Exposure concentrations were only reported for the two non-OECD guideline studies and were between 12.5% and 100% for topical induction and challenge. All the studies reported the test substance as not sensitizing (CIR 2016).

Furthermore, 14 studies investigated the skin sensitisation potential of polyglyceryl multi-esters (i.e., not mono-esters and not “polyesters”). Of these one was performed according to the OECD 406 guideline, one as Buehler test, four studies as GPMT, the remaining eight studies was either preliminary studies or no guideline was specified. Out of 14 studies 11 studies found no skin sensitizing effects of the test substance. One study reported that the results were inconclusive, in two preliminary studies positive reactions for skin sensitisation were observed after 24h and 48h and resolved 24h after exposure. the two preliminary studies used only two guinea pigs and a study protocol not in compliance with the recemented OECD test guidelines for skin sensitisation (CIR 2016).

Four human clinical studies were reported in CIR 2016. One study investigated the skin sensitisation potential of polyglyceryl monoesters using 114 subjects exposed to a 100%, 150μl test patch, HRIPT. The test substance did not cause skin sensitisation. Three studies used polyglyceryl multi-esters for studying the skin sensitisation potential. The first was identical in relation to test procedure (103 subjects exposed to a 100%, 150μl test patch, HRIPT) to that using polyglyceryl monoesters. The two others used 50 and 51 subjects 100%, 25μl occlusive patches. Induction 48-h, 3 x week for 3 weeks and challenge 48h following a 2-week non-treatment period. Both studies found polyglyceryl multi-esters to be non-sensitizing (CIR 2016).

Based on the animal and human clinical studies available for the group of polyglycerol fatty acid esters, which all showed that dermal exposure to polyglycerol mono- and multi-esters did not cause skin sensitation, it can with a high degree of confidence be concluded that the same can also be assumed for "Reaction product of saturated palm kernel fatty acids and oxybispropanediol". Thus, "Reaction product of saturated palm kernel fatty acids and oxybispropanediol" is not to be classified as a skin sensitizer.

Endpoint conclusion:

no adverse effect observed (not sensitising)

Endpoint conclusion:

no study available

No studies are available for the substance "Reaction product of saturated palm kernel fatty acids and oxybispropanediol". Data were therefore obtained for the group of polyglyceryl fatty acid esters (mono and multi-esters).

Based on the animal and human clinical studies available for the group of polyglycerol fatty acid esters, which all showed that dermal exposure to polyglycerol mono- and multi-esters did not cause skin sensitisation, it can with a high degree of confidence be concluded that the same can also be assumed for Reaction product of saturated palm kernel fatty acids and oxybispropanediol. Thus, "Reaction product of saturated palm kernel fatty acids and oxybispropanediol" is not to be classified as a skin sensitizer.