Fatty acids, C16-18, esters with ethylene glycol

Endpoint summary

Description of key information

Skin sensitisation: not sensitising (OECD 406, category approach)

 

The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114551285-49-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 22 July 2024 and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114546559-35-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 22 July 2024 and the hazard assessment will be re-evaluated accordingly.

For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.

 

CAS 853947-59-8

The skin sensitising potential of Butylene glycol dicaprylate / dicaprate was investigated in a Guinea pig maximisation test according to OECD guideline 406 under GLP conditions (Mürmann, 1992a).

Following a preliminary range finding test, female Dunkin Hartley guinea pigs (20 in test group, 10 in control group) were induced with a single intradermal injection of the test substance at 10% in maize germ oil MEH56. Epicutaneous occlusive application of the undiluted test substance was performed 7 days later. The negative control group was treated with maize germ oil MEH56. Epicutaneous challenge exposures were conducted 20 days after the first induction for 24 h under occlusive conditions. The undiluted test substance was applied on the right flank and evaluation of skin reactions was carried out 24 and 48 h after application. After intradermal injection of Freund´s adjuvans and test substance or vehicle only, all test and control animals showed severe erythema and oedema after 24 h. After challenge, all test and control animals showed no skin reactions after 24 and 48 h. The sensitivity of the test system was reported to be checked at regular intervals; however, the data were not included in the study report (Mürmann, 1992a).

In summary, based on the available data on the skin sensitisation properties, it is concluded, that there is no evidence of sensitising properties of Butylene glycol dicaprylate / dicaprate.

 

CAS 29059-24-3

The skin sensitising potential of Myristic acid, monoester with propane-1,2-diol (CAS 29059-24-3)was investigated in a Guinea pig maximisation test according to EU method B.6 (Kästner, 1989). In a preliminary range finding test was conducted to evaluate the suitable concentrations for the main study for the intradermal injection and the patch testing. In the main study, 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 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 concentrations of 2.5% and 5% of the test substance, respectively. All test and control animals showed no skin reactions after 24 and 48 h with one exception only. In one control animal, a slight redness of the skin after 48 h was apparent. No positive control data was included in the study report for reliability check (Kästner, 1989)

 

CAS 37321-62-3

The skin sensitising potential of Dodecanoic acid, ester with 1,2-propanediol (CAS 37321-62-3) was investigated in a Guinea pig maximisation test according to OECD guideline 406 under GLP conditions (Mürmann, 1992b). Following preliminary range finding tests, male and female Dunkin Hartley guinea pigs (20 in test group, 10 in control group) were induced with a single intradermal injection of the test substance at 10% in corn oil. Epicutaneous occlusive application of the undiluted test substance was performed 7 days later. The negative control groups were treated with corn oil. Epicutaneous challenge exposures were conducted 20 days after the first induction for 24 h under occlusive conditions. The undiluted test substance was applied on the right flank and evaluation of skin reactions was carried out 24, 48 and 72 h after application. After intradermal injection of Freund´s adjuvans and test substance or vehicle only, all test and control animals showed severe erythema and oedema after 24 h. After challenge, all test and control animals showed no skin reactions after 24, 48 and 72 h. The sensitivity of the test system was reported to be checked at regular intervals; however, the data were not included in the study reports (Mürmann, 1992b).

In summary, based on the available data on the skin sensitisation properties, it is concluded, that there is no evidence of sensitising properties of Dodecanoic acid, ester with 1,2-propanediol.

 

 

CAS 627-83-8

One study each, investigating the skin sensitising potential of ethylene distearate (CAS No. 627-83-8) is available in humans and animals, respectively.

The animal study was performed according to a Buehler test protocol similar to OECD guideline 406 in Hartley guinea pigs (Müller, 1984). The solid test material was mixed with a few drops of water and applied at a concentration of 100% for epidermal induction and challenge. 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. In addition, a sensitisation study with guinea pigs with limited details is available (Elder, 1982). Two animals were intradermally induced and challenged with 0.1% glycol distearate in a saline solution and showed no skin reactions.

In summary, based on all available data, ethylene distearate is not sensitising.

 

Additional data

In addition, the category members Glycol Stearate (CAS 111-60-4) and Fatty acids, C18 and C18 unsatd. epoxidized, ester with ethylene glycol (CAS 151661-88-0) did not show skin sensitisation properties, as well.

 

Conclusion for skin sensitisation properties

In conclusion, no skin sensitisation properties of the category members Ethylene distearate (CAS 627-83-8), Myristic acid, monoester with propane-1,2-diol (CAS 29059-24-3), Butylene glycol dicaprylate / dicaprate (CAS 853947-59-8) and Dodecanoic acid, ester with 1,2-propanediol (CAS 37321-62-3) were apparent in several in vivo studies. Altogether, the available data were consistently negative and thus there is no evidence for skin sensitisation properties of any category member of the Glycol Ester group.

 

For a detailed reference list please refer to the CSR or IUCLID section 13.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the group concept is applied to the members of the Glycol Ester Category, data will be generated from representative reference substance(s) within the category to avoid unnecessary animal testing. Additionally, once the group concept is applied, substances will be classified and labeled on this basis.

Therefore, based on the group concept, all available data on 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.