Registration Dossier
Registration Dossier
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EC number: 928-842-2 | CAS number: 1184648-08-5
Endpoint summary
Administrative data
Description of key information
Skin Irritation, rabbit [(R)-2-(4-hydroxyphenoxy)-propanoic acid]: non-irritating (Liggett 1991)
Eye Irritation, rabbit [(R)-2-(4-hydroxyphenoxy)-propanoic acid]: severe ocular lesions, cornea score 4 (Liggett 1991)
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation/ corrosion and eye irritation of potassium (R)-2-(4-hydroxyphenoxy)propionate, (CAS 1184648-08-5) were determined by read-across from skin irritation/ corrosion and eye irritation studies conducted with the free acid, namely (R)-2-(4-hydroxyphenoxy)propanoic acid (CAS 94050-90 -5).
Skin:
Only a single study conducted according to a guideline (EEC Directive 84/449/EEC Method B.4) and under GLP is available for the source substance (R)-2-(4-hydroxyphenoxy)-propanoic acid (CAS 94050-90-5). The study is considered to be relevant, reliable (Klimisch 1) and adequate for the purposes of risk assessment, classification and labelling. No irritating effect was observed in any of the three rabbits tested.
The skin irritation potential of the target substance propanoic acid, 2-(4-hydroxyphenoxy)-, potassium salt (2R) (CAS 1184648-08-5) is determined by read-across from the test with the free acid. The analogue approach is based on the facts that source and target contain the identical molecular structure and the same functional groups (except the K+ counterion), and that the K+ salt is expected to have a next-to-neutral pH, below 8.5 - 9. The additional amount of potassium applied to the skin is not expected to permeate the skin due to its ionic nature, therefore it is not taken up and will not elicit systemic adverse effects.
As a conclusion, propanoic acid, 2-(4-hydroxyphenoxy)-, potassium salt (2R) is not expected to be a skin irritant.
Eye:
Only a single study conducted according to European guideline (EEC Directive 84/449/EEC Method B.4) and under GLP is available for the source substance (R)-2-(4-hydroxyphenoxy)-propanoic acid (CAS 94050-90-5). The study is considered to be relevant, reliable (Klimisch 1) and adequate for the purposes of risk assessment, classification and labelling. An initial test with one animal revealed severe ocular lesions (dense corneal opacity on entire surface) after 1 hour; the study was terminated one hour after application, for humane reasons.
From the data, it cannot be decided whether this severe ocular response reflects effects of low pH or structural properties common to the source and the target molecule, e.g. the phenolic group. In addition, concentrated potassium salts such as KCl are also eye irritants.
It cannot be excluded by read-across that the target substance, propanoic acid, 2-(4-hydroxyphenoxy)-, potassium salt (2R) (CAS 1184648-08-5) may be irritant with the risk of serious damage to the eye.
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Skin Irritation/Corrosion
With a mean score of 0 the substance is considered to be non-irritating to skin based on the criteria outlined in the EU classification R38. Therefore the substance is not classified, according to the criteria in Directive 2001/59/EC, Annex VI, 3.2.6.1.
With a mean score of 0 the substance is considered to be non-irritating to skin based on the criteria as outlined in Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.2.2.7. Therefore the substance is not classified, according to the criteria in Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.2.2.
Eye Irritation
With a cornea score of 4 the substance is considered to cause serious damage to eyes based on the criteria outlined in the EU classification R41. Therefore the substance is classified as irritant, according to the criteria in Directive 2001/59/EC, Annex VI, 3.2.6.2.
With a cornea score of 4 the substance is considered to cause serious damage to eyes based on the criteria as outlined in Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.3.2.6.1. Therefore the substance is classified for serious eye damage, Category 1 (H318), according to the criteria in Regulation (EC) No. 1272/2008, Annex I, Part 3, 3.3.2.
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