Registration Dossier

Administrative data

Description of key information

Skin, rabbit (WoE): not irritating
Eye, rabbit (WoE): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for analogue read-across

Data on the skin and eye irritation/ corrosion 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 irritation

 

CAS 67762-53-2

A dermal irritation study was performed according to OECD guideline 404 with Fatty acids, C5-9 tetraesters with pentaerythritol (Zolyniene, 1999). The clipped skin of three female New Zealand White rabbits was exposed to 0.5 mL undiluted test material for 4 hours under semiocclusive conditions. The skin reactions were assessed 1, 24, 48 and 72 hours after removal of the test substance. All three animals showed very slight to well defined erythema (score 1-2) 1 hour after patch removal, while only 1/3 animals had very slight erythema 24 hours after patch removal. The skin effect was completely reversible within the 48-hour reading time point. The mean erythema scores over 24, 48 and 72 hours were 0, 0 and 0.33. No edema was noted in any of the tested animals at any reading time point, leading to mean scores over 24, 48 and 72 hours of 0, 0 and 0. The test material is not considered irritating to the skin in this study.

 

CAS 7299-99-2

The dermal irritation potential of Hexanoic acid, 2-ethyl-, 2,2-bis [ [(2-ethyl-1-oxohexyl)oxy] methyl] -1,3-propanediyl ester was assessed in a study performed according to OECD guideline 404 and under GLP conditions (Bouffechoux, 1998). The shaved and abraded skin of three male New Zealand White rabbits was exposed to 0.5 mL undiluted test material for 4 hours under semiocclusive conditions. The skin reactions were assessed 4, 24, 48 and 72 hours, and 4 and 7 days after patch removal. 1/3 animals showed very slight edema (score 1) 4 hours after patch removal, while 1/3 animals (a different animal) had very slight edema 24 hours after patch removal. All skin effects were completely reversible within the 48-hour reading time point. The mean edema scores over 24, 48 and 72 hours were 0, 0.33 and 0. No erythema was noted in any of the tested animals at any reading time point, leading to mean scores over 24, 48 and 72 hours of 0, 0 and 0. The test material is not considered irritating to the skin in this study.

 

CAS 126-57-8

A supporting study for skin corrosion potential was performed according to OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test) before 26 Sept. 2014 with TRIMETILOLPROPANO TRIPELARGONATO (Andres, 2014). Two tissues of the human skin model EpiDermTM were treated with TRIMETILOLPROPANO TRIPELARGONATO for three minutes and one hour, respectively. 50 μL of the liquid test item were applied to each tissue and spread to match the tissue size. Deionised water was used as negative control, 8M KOH was used as positive control. After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT which can be reduced to a blue formazan. Formazan production was measured by measuring the optical density (OD) of the resulting solution. After treatment with the negative control, the absorbance values were well above the required acceptability criterion of mean OD > 0.8 for both treatment intervals thus showing the quality of the tissues. The positive control showed clear corrosive effects for both treatment intervals. After three minutes treatment with the test item, the relative absorbance values were reduced to 98.1 %. This value is well above the threshold for corrosion potential (50 %). After one hour treatment, relative absorbance values were reduced to 92.0 %. This value, too, is well above the threshold for corrosion potential (15 %). In the guideline, values greater or equal to the threshold are considered as “non-corrosive to skin”.

 

Eye irritation

CAS 67762-53-2

Fatty acids, C5-9, tetraesters with pentaerythritol was tested for its acute eye irritation potential in a study performed according to OECD guideline 405 (Zolyniene, 1997). 0.1 mL of the undiluted test substance was applied into one eye of each of 3 (1 male, 2 female) New Zealand White rabbits. The animals were observed for 3 days and reactions were assessed 1, 24, 48 and 72 hours after instillation according to the Draize scoring system. 3/3 animals showed slight to moderate conjunctival redness 2 hour after instillation. Slight conjunctival redness was noted in 2/3 rabbits until the 24-hour reading time point, which persisted in 1/3 until the 48-hour reading time point. All eye irritation effects had cleared completely within 72 hours after instillation. No chemosis and no iridial or corneal changes were observed in any rabbit at any time point. The mean conjunctivae score for the three animals over 24, 48 and 72 hours was 0.67, 0 and 0.33. In conclusion, the test substance was not considered irritating to the eye.

 

CAS 126-57-8

The acute eye irritation of Trimethylolpropane Tripelargonate was investigated in rabbits according to OECD Guideline 405 (Salvador, 2014). A 0.1 mL aliquot of the test item was introduced into the right eye of a total of 3 animals. The resulting reaction to treatment was assessed approximately 1, 24, 48, and 72 hours after dosing. No significant irritation at either the conjunctivae, iris or cornea was recorded in any treated animal during the study. There were no signs of pain/distress after dosing. Changes in body weight were not remarkable. There was no indication of a systemic effect related to treatment. These results indicate that the test item, Trimethylolpropane Tripelargonate, has no relevant effect on the eye of the rabbit.

 

CAS 7299-99-2

The eye irritation potential of Hexanoic acid, 2-ethyl-, 2,2-bis [ [(2-ethyl-1-oxohexyl)oxy] methyl] -1,3-propanediyl ester was assessed in a study performed according to OECD guideline 405 and under GLP conditions (Bouffechoux, 1998). The undiluted test substance (0.1 mL) was instilled into one eye of 3 male New Zealand White rabbits. The treated eye was not rinsed. The other eye remained untreated and served as the control. Examination and scoring of effects on the eyes was performed at intervals of 4, 24, 48 and 72 h, and 7 days after test substance instillation. Four hours after instillation of the test substance, 3/3 animals had moderate (score 2) conjunctival redness. At the 24 -hour reading time point, the irritation effect had reduced in severity to slight redness (score 1) in 3/3 rabbits, which cleared completely within 48 hours after instillation. No chemosis was observed, and no irritation effects were seen on the iris and cornea in any animal at any reading time point. No further local or systemic adverse effects were observed. In conclusion, the test substance was not considered irritating to the eye.

 

Overall conclusion for skin and eye irritation

The available data on suitable source substances did not show any skin or eye irritation effects. Therefore, the target substance Pentaerythritol, mixed esters with linear and branched fatty acids is not expected to be a skin irritant or an eye irritant.

 

Justification for selection of skin irritation / corrosion 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).

 

Justification for selection of eye irritation 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).

 

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.

The available data on skin and eye irritation 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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