Registration Dossier

Toxicological information

Eye irritation

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Administrative data

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

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

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.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: Paste
Details on test material:
Same ID as the registered substance

Results and discussion

In vivo

Results
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

Applicant's summary and conclusion

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.