Fatty acids, C8-10-(even numberd), Esters with pentaerythritol and adipic acid

Endpoint summary

Description of key information

Skin irritation (in vitro/in vivo): not irritating (read-across)

Eye irritation (in vitro/in vivo): not irritating (read-across)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Irritation / corrosion parameter:

% tissue viability

Run / experiment:

mean of 3 tissues

Value:

99.4

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Source: CAS 95912-89-3

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

The skin irritation potential of the target substance is estimated based on an adequate and reliable in vitro study from the structural analogue source substance CAS 95912-89-3. In the study following the reconstructed human epidermis test method, no skin irritation was observed. The target and the source substance are considered unlikely to differ in their skin irritation potential. Therefore, the target substance Fatty acids, soya, isopropyl esters (CAS 95913-46-7) is not expected to have a skin irritating potential.

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 11138-60-6

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 11138-60-6

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

The skin irritation potential of the target substance is estimated based on an adequate and reliable in vivo study from the structural analogue source substance CAS 11138-60-6. In the study following the OECD 404 test method, no skin irritation was observed. The target and the source substance are considered unlikely to differ in their skin irritation potential. Therefore, the target substance Fatty acids, soya, isopropyl esters (CAS 95913-46-7) is not expected to have a skin irritating potential.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Remarks:

Summary of available data used for the endpoint assessment of the target substance

Adequacy of study:

key study

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

in vitro irritation score

Run / experiment:

10 min of exposure

Value:

0.217

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: Source: CAS 95912-89-3

Interpretation of results:

other: on-corrosive (Eye Irrit. 2 or not classified) according to Regulation (EC) No 1272/2008

Conclusions:

The eye irritation/corrosion potential of the target substance is estimated based on an adequate and reliable in vitro study from the structural analogue source substance CAS 95912-89-3. In the study following the bovine corneal opacity and permeability test method, no eye corrosion was observed. The result does not allow for the non-classification or classification as irritant of the source substance CAS 95912-89-6 and therefore further evaluation and/or data generation is required.
In an in vivo eye irritation study performed with the source substance CAS 11138-60-6, no eye irritating properties were observed.
The read-across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their eye irritation/corrosion potential. The target substance Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid is not expected to have an eye irritating potential.

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

refer to analogue justification provided in IUCLID section 13

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 11138-60-6

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 11138-60-6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 11138-60-6

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of all 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: not applicable

Remarks on result:

other: Source: CAS 11138-60-6

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008

Conclusions:

The eye irritation potential of the target substance is estimated based on an adequate and reliable in vivo study from the structural analogue source substance CAS 11138-60-6. In the study following the OECD 405 test design, no eye irritation was observed. The target and source substances are considered unlikely to differ in their eye irritation potential. The target substance Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid is not expected to have an eye irritating potential.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for read-across

Experimental data on skin and eye irritation of Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid 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 95912-89-3

A GLP-conform in vitro skin irritation study according to OECD 439 was performed with Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS 95912-89-3) (Key, 2012). In this study, a reconstructed three-dimensional human epidermis model was used to investigate the effects of the undiluted test substance on the viability of epidermal keratinocytes. After 60-min exposure to the test substance, the viability of human keratinocytes was 99.4% compared to the negative control PBS (100%). The positive control 5% SDS significantly reduced the viability of cells compared to the negative control, thus fulfilling the criteria for the acceptability of the assay (relative viability ≤ 20%). Since the mean relative tissue viability was ≥ 50% after 60 minutes of treatment, the test substance was considered to be non-irritant to human skin according to the criteria laid down in OECD 439. Based on the results of this study, Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane is not irritating to the skin.

CAS 11138-60-6

A primary dermal irritation study was conducted with Fatty acids, 8-10 (even numbered), di- and triesters with propylidynetrimethanol (CAS 11138-60-6) (Key, 1990). The back of three New Zealand White rabbits was exposed to 0.5 mL test material for 4 hours under semi-occlusive conditions. The rabbits were observed for 72 h after exposure and skin reactions were assessed using the Draize scheme periodically (24, 48 and 72 hours) after removal of the test substance. No cutaneous reactions were observed in any of the tested animals at any observation interval.

Eye irritation

CAS 95912-89-3

A Bovine Corneal Opacity and Permeability (BCOP) test was performed according to OECD 437 to assess the potential ocular corrosivity and severe eye irritation potential of Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane (CAS 95912-89-3) (Key, 2013). In this GLP-conform study, the test substance at a 10% solution in olive oil was applied to the epithelial surface of the isolated cornea of cattle for 10 min, followed by a 2-h post-exposure incubation period. After exposure, no changes in opacity and permeability were observed in corneas compared to control. Based on the measurements for opacity and permeability, an In Vitro Irritancy Score (IVIS) ≤ 55 was calculated after treatment with the test substance (IVIS of the test substance= 0.217). The positive and negative controls showed the expected results, thereby confirming the validity of the assay. Based on the results of the study, no risk for serious damage to the eyes was identified. However, negative in vitro corrosivity responses are not conclusive concerning non-classification or classification as an irritant and shall, therefore, be subject to further evaluation.

CAS 11138-60-6

An in vivo eye irritation study was conducted with Fatty acids, 8-10 (even numbered), di- and triesters with propylidynetrimethanol (CAS 11138-60-6). The substance was tested for eye irritation potential according to OECD 405 (Key, 1990). 0.1 mL of the test material was instilled into the conjunctival sac of one eye of three New Zealand White rabbits. Animals were observed for 72 hours and then the observed effects were scored at 24, 48 and 72 hours after instillation according to 84/499/EEC appendix V B5 (Draize). No effects, except for one animal with a very slight exudation reaction at the 24 h time point, were observed in any of the tested animals at any relevant observation interval.

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 Fatty acids, C8-10-(even numbered), esters with pentaerythritol and adipic acid 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 and eye irritation do not meet the classification criteria according to Regulation (EC) No. 1272/2008 and are therefore conclusive but not sufficient for classification.