Registration Dossier
Registration Dossier
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EC number: 277-554-7 | CAS number: 73612-40-5
Endpoint summary
Administrative data
Description of key information
Skin: not irritating, not corrosive
Eye: not irritating, not corrosive
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
Skin irritation/corrosion
The irritation/corrosion property was tested on the substance, according to the OECD404 and EU B.4, in GLP.
Under the conditions of the experiment, the tested substances were found to not cause corrosion or irritating effects on animals skin.
One OECD404 non-GLP study and an AFDO (US Association of Food and Drug Officials method) study, support the evaluation.
According to the results, the registered substance is considered non irritant for the skin.
Eye irritation/corrosion
The irritation/corrosion property was tested on the substance, according to the OECD405 and EU B.5, in GLP.
Under the conditions of the experiment, the tested substances were found to not cause corrosion or irritating effects.
One OECD 405 non-GLP study, and two AFDO (US Association of Food and Drug Officials method) studies, support this evaluation, considering the score detected on rinsed eyes. As a matter of fact, according to OECD405, the eyes may be rinsed with saline or distilled water, therefore the results detected on not-rinsed eyes were not taken into account.
According to the results, the registered substance is considered non irritant for the eyes.
Justification for classification or non-classification
Skin irritation/corrosion
Substances that have the potential to induce reversible skin irritation are classified in Category 2 (irritating to skin).
According to the CLP Regulation 1272/2008, the substance can be classify as a single irritant category (Category 2) according to the criteria, section 3.2, table 3.2.2.
If, when applied to the skin of an animal, the substance produces:
(1) Mean value of ≥ 2,3 - ≤ 4,0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from grading 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. Reversibility of skin lesions is the other decisive factor in evaluating responses in the animal test.
Under the conditions of the experiments, the tested substance was found to be non irritant to the animals skin, showing
Erithema (mean 24, 48, 72 hours):
animal 1: 0.67
animal 2: 1.0
animal 3: 1.0
Edema (mean 24, 48, 72 hours):
animal 1: 0.0
animal 2: 0.33
animal 3: 0.33
According to the paragraph 3.2. of the CLP Regulation n. 1272/2008, the substance is not classified as a skin irritant/skin corrosive.
Eye irritation/corrosion
Substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes).
According to the CLP Regulation 1272/2008, using the results of animal testing the substance can be classify as a single irritant category (Category 2) according to the criteria, section 3.3, table 3.3.2
If, when applied to the eye of an animal, the 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 values of the recordings from 24 to 72 hours after application in rinsed eyes, are:
Cornea (mean 24, 48, 72 hours):
animal 1: 0.0
animal 2: 0.0
animal 3: 0.0
Iris (mean 24, 48, 72 hours):
animal 1: 0.0
animal 2: 0.0
animal 3: 0.0
Conjuntivae-redness (mean 24, 48, 72 hours):
animal 1: 0.33
animal 2: 0.33
animal 3: 0.33
Conjuntivae-chemosis (mean 24, 48, 72 hours):
animal 1: 0.0
animal 2: 0.0
animal 3: 0.0
According to the paragraph 3.3 of the CLP Regulation n. 1272/2008, the substance is not classified as eyes irritant/corrosive.
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