Registration Dossier

No studies are available for “Reaction product of saturated palm kernel fatty acids and oxybispropanediol”. Data on skin and eye irritation were therefore obtained for the group of polyglyceryl esters in the UVCB substance (CIR 2016).

The available data for polyglycerols and polyglyceryl fatty acid esters on skin irritation from in vitro (cell assays) and in vivo (animal and human data) points towards no/minimal irritation. The described OECD testing guideline data are considered valid, even though the full test report is not available for a thorough evaluation in relation to the application of CLP classification criteria for skin irritation category 2. Based on an overall weight of evidence, the CLP criteria for classification is not fulfilled, thus no classification should be applied.

The human and animal studies on eye irritation of polyglyceryl esters pointed in both directions about positive and negative findings on eye irritation. Half of the studies in rabbits found minimal irritative effects on the eye, which all were completely reversible within 24- 48h. In the human clinical study, possibly slight irritating effects were found on the eyes. However, the information about the study-design was insufficient and will not score high in the overall evaluation of the eye irritating potential.

Based on an overall weight of evidence from the available data it is concluded that “Reaction product of saturated palm kernel fatty acids and oxybispropanediol” is not to be classified for skin- and eye irritation, as the CLP criteria for classification is not fulfilled. In support, CIR (2016) concluded that polyglyceryl fatty acid esters are safe in cosmetics.

Reference

Endpoint:

skin irritation: in vivo

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 irritation potential 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 irritation potential, 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.

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 irritant

Interpretation of results:

GHS criteria not met

Conclusions:

No studies are available for “Reaction product of saturated palm kernel fatty acids and oxybispropanediol”. Data on skin irritation were therefore obtained for the group of polyglyceryl esters in the UVCB substance (CIR 2016). Results from the human and animal studies on skin irritation of Polyglyceryl esters were mostly negative results on skin irritation. Therefore, it is considered most likely that the same will apply for “Reaction product of saturated palm kernel fatty acids and oxybispropanediol”. Based on an overall weight of evidence from the available data it is concluded that “Reaction product of saturated palm kernel fatty acids and oxybispropanediol” is not to be classified for skin irritation, as the CLP criteria for classification is not fulfilled.

Executive summary:

No studies are available for “Reaction product of saturated palm kernel fatty acids and oxybispropanediol”. Data on skin irritation were therefore obtained for the group of polyglyceryl esters in the UVCB substance (CIR 2016).

The available data for polyglycerols and polyglyceryl fatty acid esters on skin irritation from in vitro (cell assays) and in vivo (animal and human data) points towards no/minimal irritation. The described OECD testing guideline data are considered valid, even though the full test report is not available for a thorough evaluation in relation to the application of CLP classification criteria for skin irritation category 2. Based on an overall weight of evidence, the CLP criteria for classification is not fulfilled, thus no classification should be applied. In support, CIR (2016) concluded that polyglyceryl fatty acid esters are safe in cosmetics.

Endpoint conclusion:

no adverse effect observed (not irritating)

Reference

Endpoint:

eye irritation: in vivo

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 irritation potential 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 eye irritation potential, 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.

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 an eye irritant

Interpretation of results:

GHS criteria not met

Conclusions:

No studies are available for “Reaction product of saturated palm kernel fatty acids and oxybispropanediol”. Data on eye irritation were therefore obtained for the group of polyglyceryl esters in the UVCB substance (CIR 2016). Results from the human and animal studies on skin irritation of Polyglyceryl esters were mostly negative results on eye irritation. Therefore, it is considered most likely that the same will apply for “Reaction product of saturated palm kernel fatty acids and oxybispropanediol”. Based on an overall weight of evidence from the available data it is concluded that “Reaction product of saturated palm kernel fatty acids and oxybispropanediol” is not to be classified for eye irritation, as the CLP criteria for classification is not fulfilled.

Executive summary:

No studies are available for “Reaction product of saturated palm kernel fatty acids and oxybispropanediol”. Data on eye irritation were therefore obtained for the group of polyglyceryl esters in the UVCB substance (CIR 2016).

The human and animal studies on eye irritation of polyglyceryl esters pointed in both directions about positive and negative findings on eye irritation. Half of the studies in rabbits found minimal irritative effects on the eye, which all were completely reversible within 24- 48h. In the human clinical study, possibly slight irritating effects were found on the eyes. However, the information about the study-design was insufficient and will not score high in the overall evaluation of the eye irritating potential.

Based on an overall weight of evidence from the available data it is concluded that “Reaction product of saturated palm kernel fatty acids and oxybispropanediol” is not to be classified for eye irritation, as the CLP criteria for classification is not fulfilled.

Endpoint conclusion:

no adverse effect observed (not irritating)

Endpoint conclusion:

no study available

Based on an overall weight of evidence from the available data it is concluded that “Reaction product of saturated palm kernel fatty acids and oxybispropanediol” is not to be classified for skin- and eye irritation, as the CLP criteria for classification is not fulfilled. In support, CIR (2016) concluded that polyglyceryl fatty acid esters are safe in cosmetics.