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Administrative data

Description of key information

Skin, rabbit (Read-across, OECD 404): not irritating

Eye, rabbit (Read-across, OECD 405): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in 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
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean over
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: Source: CAS 68586-51-7
Irritation parameter:
erythema score
Basis:
animal: #2 and #3
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: Source: CAS 68586-51-7
Irritation parameter:
edema score
Basis:
animal: #1, #2, and #3
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: Source: CAS 68586-51-7

An in vivo skin irritation study in rabbits with the source substance decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) was selected as key result for reasons of structural similarity and data reliability. Supporting in vivo skin irritation data is given for the source substance ethylene distearate (CAS 627-83-8), where no oedema and erythema was found in rabbits after 25 h exposure to the undiluted test material.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their skin irritation potential. No in vivo skin irritation potential was found in rabbit studies for the two source substances with structural similarity. Therefore, no skin irritation potential is expected for target substance Reaction mass of 2-hydroxyethyl laurate and ethylene dilaurate (EC 908-917-6).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in 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
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, and #4
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: Source: CAS 68583-51-7
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, and #4
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable
Remarks on result:
other: Source: CAS 68583-51-7
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3, and #4
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility not applicable
Remarks on result:
other: Source: CAS 68583-51-7
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, and #4
Remarks:
individual mean over
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable
Remarks on result:
other: Source: CAS 68583-51-7

An in vivo eye irritation study in rabbits with the source substance decanoic acid, mixed diesters with octanoic acid and propylene glycol (CAS 68583-51-7) was selected as key result for reasons of structural similarity and data reliability. Supporting in vivo data on eye irritation is given for the source substance ethylene distearate (CAS 627-83-8). No or only mild in vivo eye irritation potential was found for both source substances.

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their eye irritation potential. No in vivo eye irritation potential was found in rabbit studies with two source substances. Therefore, no eye irritation potential is expected for target substance Reaction mass of 2-hydroxyethyl laurate and ethylene dilaurate (EC 908-917-6).
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are no adequate study data on the skin and eye irritation effects of Reaction mass of 2-hydroxyethyl laurate and ethylene dilaurate. The assessment was therefore based on studies conducted with 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 source substance(s) is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Read-across is justified based on different compounds having the same type of effect(s) as described in scenario 2 of the Read-Across Assessment Framework (Read-Across Assessment Framework (RAAF), European Chemicals Agency, Helsinki, Finland, 2017. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).

Skin irritation

CAS 68583-51-7

The skin irritation properties of decanoic acid, mixed diesters with octanoic acid and propylene glycol were tested in a study performed according to OECD guideline 404 and under GLP conditions (key study, 1989). In the study, 3 New Zealand White rabbits were exposed to 0.5 mL of the undiluted test substance, which was applied to the shaved skin for 4 h using a semi-occlusive dressing. The treated skin was observed and evaluated for skin irritating effects at 1, 24, 48 and 72 h post-application. In 1/3 animals 24 h after removal of the test substance, slight erythema (score 1) was observed which was fully reversible within 48 h (mean erythema score 0.3 over 24, 48 and72 h). The remaining animals revealed no erythema formation. No oedema formation or further local or systemic effects were apparent in any animal during the study period. The individual erythema scores as means over the 24, 48 and 72 hour-readings were 0.3, 0.0 and 0.0 for the three animals. The individual oedema scores as means over the 24, 48 and 72 hour-readings were 0.0 for each of the three animals.

CAS 627-83-8

The skin irritation properties of ethylene distearate were tested in a study performed equivalent to OECD guideline 404 and under GLP conditions (supporting study, 1991). In the study, 3 male and 3 female New Zealand White rabbits were exposed to 0.5 g of the unchanged test substance, which was applied to the shaved and abraded skin for 25 hours using an occlusive dressing. The treated skin was observed and evaluated at 25 and 72 hours post-application. No erythema or oedema was observed in any animal during the study period on intact shaved skin. The individual erythema and oedema scores as means over the 25 and 72 h-readings were 0.0 for each of the six animals.

Eye irritation

CAS 68583-51-7

The eye irritation properties of decanoic acid, mixed diesters with octanoic acid and propylene glycol were tested in a study according to OECD guideline 405 and under GLP conditions (key study, 1988). In a group of 4 male rabbits (Kleinrusse), 0.1 mL of the undiluted test substance was applied into one eye, in a single application without washing. The eyes were observed and reactions were evaluated 1, 6, 24, 48 and 72 h after application. No effects on corneal opacity and iris were noted at any time point in any animal. However, mild conjunctival redness was observed in 2/4 animals at the 1 h reading time point. In one of these animals the effect was fully reversible within 6 h; in the second animal mild redness was apparent until 6 h after application and fully reversible after 24 h. No chemosis or exudation was observed during the study period in any animal. No further local or systemic effects were observed in any animal during the study period. The individual conjunctivae, chemosis, iris, and corneal opacity scores as means over the 24, 48 and 72 hour-readings were 0.0 for each of the four animals.

Based on the obtained results, decanoic acid, mixed diesters with octanoic acid and propylene glycol is not eye irritating.

CAS 627-83-8

The eye irritation properties of ethylene distearate were tested in a study performed similar to OECD guideline 405 (supporting study, 1991, T870). In a group of 6 New Zealand white rabbits, 0.1 g of the test substance was applied into the eye. Observation of the eyes was performed 24, 48 and 72 h after application. No effects on cornea and iris were noted in any animal during the study period. However, mild conjunctival redness (score 1) was observed in 4/6 animals after 24 h and in 2/6 animals moderate redness (score 2) was apparent. In 2 animals the mild redness was still persistent after 72 h. Chemosis of score 1 was observed in 1/6 animals after 24 h; this effect was fully reversible within 48 h. No chemosis was observed in the remaining 5 animals during the study period. No further systemic effects or abnormal behaviour were observed in any animal during the study period. The individual conjunctivae scores as means over the 24, 48 and 72 hour-readings were 1.0, 0.67, 1.33, 0.33, 1.0, and 0.33 for the six animals.

 

An additional study of the same laboratory with ethylene distearate similarly to OECD guideline 405 was conducted (supporting study, 1991, T873). No effects on cornea and iris were apparent in any animal during the study period and no chemosis was observed in the test animals. Mild to moderate conjunctival redness was observed in all animals, which was fully reversible within 72 h post-instillation. The individual conjunctivae scores as means over the 24, 48 and 72 hour-readings were 1.0, 0.33, 1.0, 0.33, 0.67, and 0.33 for the six animals. No further local or systemic signs of toxicity were apparent in the test animals.

 

Overall conclusion for skin and eye irritation

The available data from source substances do not indicate any skin or eye irritation potential. Therefore, no skin or eye irritation potential is anticipated for the target substance Reaction mass of 2 -hydroxyethyl laurate and ethylene dilaurate.

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 Reaction mass of 2-hydroxyethyl laurate and ethylene dilaurate 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) No. 1272/2008 and are therefore conclusive but not sufficient for classification.