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 analogue read-across

Data on the skin sensitisation potential of Pentaerythritol, mixed esters with linear and branched fatty acids are not available. The assessment was therefore based on studies conducted with analogue (source) substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

 

Skin sensitisation

 

Animal data

CAS 67762-53-2

The skin sensitisation potential of Fatty acids, C5-9, tetraesters with pentaerythritol was assessed in a Guinea pig maximisation test (GMPT) performed according to OECD guideline 406 (Zolyniene, 1999). 10 treatment and 5 control guinea pigs were induced intradermally with 5% test substance in propylene glycol on both sides of the spine with and without Freud's complete adjuvant. On Day 7, the application sites were treated with sodium lauryl sulfate to induce skin irritation. On Day 8, a 48-hour epicutaneous induction treatment with the undiluted test substance was performed (under occlusive conditions). On Day 22, the challenge treatment was performed by topical application of the undiluted test substance and 50% dilution on opposite flanks to all animals for 24 hours, under occlusive conditions. Skin reactions were evaluated 24 and 48 hours after the challenge application. During the study, no test substance-related clinical signs and no effects on body weight gain were observed. 1/5 control animals was sacrificed on Day 10 due to a dosing error. No skin reactions were observed after the challenge treatment in any of the animals of the test and control groups. The result of the reliability check carried out with hexylcinnamic aldehyde was positive, confirming the reliability of the assay. Based on the results, the test substance had no sensitising effect in guinea pigs under the experimental conditions.

 

CAS 126-57-8

The skin sensitisation potential of Trimethylolpropane Tripelargonate was assessed in a Guinea pig maximisation test (GMPT) performed according OECD guideline 406 and the European Directive B6 (Salvador, 2014). 10 treatment and 5 control guinea pigs were induced intradermally with 20% test substance in corn oil on both sides of the spine. On Day 8, a 48-hour epicutaneous induction treatment with the undiluted test substance was performed (under occlusive conditions). On Day 22, the challenge treatment was performed by topical application of the vehicle alone on one side and 20% dilution on opposite flanks to all animals for 24 hours, under occlusive conditions. Skin reactions were evaluated 24 and 48 hours after the challenge application. No visible changes were observed. Based on the results, the test substance had no sensitising effect in guinea pigs under the experimental conditions Study showed that substance does not induce and elicit delayed dermal sensitisation in the guinea pig.

 

Human data

CAS 7299-99-2

A non-guideline repeated insult human patch test (RIPT) was conducted to assess the sensitizing potential of Hexanoic acid, 2-ethyl-, 2,2-bis [ [(2-ethyl-1-oxohexyl)oxy] methyl] -1,3-propanediyl ester in 29 male and 84 female volunteers from the general population, aged 18 – 65 years (Tolman and Harrison, 1997). During the induction phase, volunteers were subjected to 9 repeated occlusive applications of the undiluted test substance during a period of 3 weeks. Patches were placed on the back of volunteers for 24 hours, followed by a rest period. The 9 induction patches were applied to the same site. The induction phase was followed by a resting period of 14 days. A challenge patch was applied to a naïve site on the back, once only. Skin reactions were assessed 24, 48, 72 and 96 hours after patch removal. None of the human volunteers showed any skin reactions at the end of the study period. Therefore, the test substance is not considered sensitising to humans under the conditions of the study.

 

Conclusion

Two GPMT studies performed with 2 source substances were negative, and the result of a human repeated insult patch test performed with a source substance was likewise negative. Taking into account the available information, Pentaerythritol, mixed esters with linear and branched fatty acids is not expected to be skin sensitising.

 

Justification for selection of skin sensitisation endpoint:

Hazard assessment is conducted by means of read-across from structural analogues. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between the source and target substance 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

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 analogue concept is applied to Pentaerythritol, mixed esters with linear and branched fatty acids, data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

Therefore, 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, and are therefore conclusive but not sufficient for classification.


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