Registration Dossier
Registration Dossier
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EC number: 945-131-2 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin irritation: Not irritant
Eye Irritation: Not irritant
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
No studies on the "Irritation/Corrosion" are available for the substance in itself.
Nevertheless studies were conducted with an analogue molecule (Similar Substance 01). Further information are reported in the Read Across justification attached to section 13.
The test substance has been tested during 1977 for skin and eye irritation according to AFDO Guidelines. No irreversible effect was observed during the tests. No erythema or oedema reaction have been observed after skin application; a minimal transient conjunctival reaction observed during eyes test within the 6 hours exposure period, all evaluation parameters were fully reversible during the 24 hours period.
Justification for classification or non-classification
Skin Irritation
According to the CLP Regulation (EC n. 1272/2008), skin corrosion means the production of irreversible damage to the skin, and skin irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
A substance has to be classified as Category 1 (Corrosive) if there is the production of irreversible damage to the skin in more than 1 of three animals.
A substance has to be classified as Category 2 (Irritant) if shows:
(1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
(2) Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
(3) In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure in a single animal but less than the criteria above.
No Oedema and no Erythema reaction have been observed during the test. The mean values for erythema and for oedema were 0 in all the tested animals therefore the test substance does not need to be classified according to the CLP Regulation.
Eye Irritation
According to the CLP Regulation (EC n. 1272/2008), Serious eye damage means the production of tissue damage in the eye, or serious physical decay of vision, following application of a test substance to the anterior surface of the eye, which is not fully reversible within 21 days of application
Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.
A substance has to be classified as Category 1 (Irreversible effects on the eye), If, when applied to the eye of an animal, a substance produces:
— at least in one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/ or
— at least in 2 of 3 tested animals, a positive response of:
— corneal opacity ≥ 3 and/or
— iritis > 1,5 calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material.
A substance has to be classified as Category 2 (irritating to eye) if, when applied to the eye of an animal, a substance produces:
at least in 2 of 3 tested animals, a positive response of:
- corneal opacity ≥ 1 and/or
- iritis ≥ 1, and/or
- conjunctival redness ≥ 2 and/or
- conjunctival oedema (chemosis) ≥ 2
calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.
The mean scores for the test substance calculated following grading at 24, 48 and 72 hours after instillation of the test material to the eye, were 0 for corneal opacity, iritis, conjunctival redness and corneal opacity for all tested animals.
Based on the provided data no classification for eye irritation is warranted under the CLP Regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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