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:

Justification for read-across

There are no data for sensitisation available for Propyleneglycol dioleate. In accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5 read-across from appropriate substances is conducted to fulfill the standard information requirements set out in Regulation (EC) No 1907/2006, Annex VII, 8.3.

According to Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met”. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across) “to avoid the need to test every substance for every endpoint”. 

Propyleneglycol dioleate represents an UVCB substance comprised of diesters of 1,2-propyleneglycol chemically linked to mainly oleic acid (C18:1) and/or palmitic and/or stearic acid (C16, C16:1).Gylcol esters are in general known to bestepwise hydrolysed by gastrointestinal enzymes into the free fatty acid component and the respective alcohol (Long, 1958; Lehninger, 1970; Mattson and Volpenhein, 1972).

Based on thecommon metabolic fate of glycol esters, the read-across approach is based on the presence ofcommon functional groups, common precursors and the likelihood of common breakdown products via biological processes, which result in structurally similar chemicals,common functional groups, structural similarities and similar physico-chemical, toxicological and toxicokinetic behaviour. For further details on the read-across approach, please refer to the analogue justification in section 13 of the technical dossier.

As no data are available on skin sensitization of Propyleneglycol dioleate, read-across to reliable data on the analogue substances Ethylene distearate (CAS 627-83-8) and Myristic acid, monoester with propane-1,2-diol (CAS 29059-24-3) was conducted.

 

CAS 627-83-8

The skin sensitising properties of Ethylene distearate were evaluated according to a Buehler test protocol similar to OECD guideline 406 in Hartley guinea pigs (Müller, 1982. The solid test material was mixed with a few drops of water and was applied at a concentration of 100% for epidermal induction (exposure once/week between Day 0 – 21 with an occlusive patch placed on the left shoulder for 6 h at each occasion) and challenge (exposure on Day 35 with an occlusive patch placed on the right shoulder for 6 h). The negative control group was treated with the vehicle only. No positive control data was included in the study report for reliability check. At challenge, the neat test substance induced no skin effects in the test and negative control group. No further skin reactions after induction and challenge were observed.

Based on the available data, Ethylene distearate is not sensitising.

 

CAS 29059-24-3

Skin sensitization of Myristic acid, monoester with propane-1,2-diol was tested in a GLP-compliant Guinea pig maximization test according to EU Method B.6 (Kästner, 1989). 20 female Pirbright white guinea pigs were induced with a single intradermal injection of the test substance at 0.1% in Paraffin perliquid DAB 8 and with an epicutaneous occlusive application of the test substance at 15% on the shoulder region 7 days later. A negative control group of 20 animals was treated with Paraffin perliquid DAB 8 only. Epicutaneous challenge exposure was conducted 20 days after the first induction for 24 h under occlusive conditions at test substance concentrations of 2.5% and 5%, respectively. All test and control animals showed no skin reactions after 24 and 48 h with one exception only. In one control animal, slight redness of the skin after 48 h was apparent. No positive control data was included in the study report for reliability check. 

In summary,Myristic acid, monoester with propane-1,2-diol did not exhibit skin sensitizing properties in the conducted study.

 

 

Conclusion on skin sensitising properties

The available data investigating the sensitisation properties of read-across analogue substances consistently showed negative results. Thus, there is no evidence to consider Propyleneglycol dioleate as skin sensitising.

 

References

Agency for Toxic Substances and Disease Registry (ATSDR) (1997). Toxicological Profile for Propylene Glycol. US Department of Health and Human Services. Atlanta, US.

Agency for Toxic Substances and Disease Registry (ATSDR) (2010). Toxicological Profile for Ethylene Glycol. US Department of Health and Human Services. Atlanta, US.

Lehninger, A.L. (1970). Biochemistry. Worth Publishers, Inc.Long, C.L. et al. (1958). Studies on absorption and metabolism of propylene glycol distearate. Arch Biochem Biophys, 77(2):428-439.

Mattson, F.H. and Volpenhein, R.A. (1972). Hydrolysis of fully esterified alcohols containing from one to eight hydroxyl groups by the lipolytic enzymes of the rat pancreatic juice. Journal of Lipid Research 13: 325-328

Miller, O.N., Bazzano, G. (1965).Propanediol metabolism and its relation to lactic acid -metabolism. Annals of the New York Academy of Sciences 119:957-973.

Ritchie, A.D. (1927). Lactic acid in fish and crustacean muscle. Journal of Experimental Biology 4: 327-332.


Migrated from Short description of key information:
skin sensitisation (Bühler, GPMT): not sensitising

Justification for selection of skin sensitisation endpoint:
Hazard assessment is conducted by means of a read-across based on a read-across from structural analogues. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment (refer to the endpoint discussion for further details).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

Justification for classification or non-classification

Based on the analogue read-across approach, 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.