Registration Dossier
Registration Dossier
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EC number: 255-217-5 | CAS number: 41098-56-0
Endpoint summary
Administrative data
Description of key information
Not skin irritating.
Not eye irritating.
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
The skin irritation potential was tested in New Zealand White rabbits on the substance under registration. The procedure is similar to those described in the OECD Guidelines 404. Slight erythema reversible within 72 hours was observed in one rabbit.
The eye irritation potential was assessed according to the in vitro Bovine Eye and the Chicken Chorioallantoic Membrane (BECAM ASSAY) method. The test substance induced no effects in the bovine eye. The effects on the CAM consisted of vascular injection almost instantly after application. In three eggs (no. 1, 3 and 4) haemorrhages were scored 2 minutes after application. On account of these results it is expected that eye contact with the test substance may lead to very slight irritation. Acute corneal effects may be negligible.
Within the whole category, eleven over fourteen registered substances were tested and none of the existing tests arisen any concern for skin and eye irritation.
All substances of the category were modelled using the OECD Toolbox and the provisional results about skin and eye irritation were calculated for all members: no alerts have been reported (see category Justification Report attached to the section 13) for inclusion for any substance.
As representative supporting data, the skin and eye irritation tests on 3a-MSA are here reported. Justification for Read Across is given in Section 13 of IUCLID
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible damage to the skin following the application of a test substance for up to 4 hours are classified in Category 2 (irritating to the skin) if :
(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.
In the skin irritation test, mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions (in both intact and abraded skin).
According to the CLP Regulation (EC 1272/2008) substances that have the potential to induce reversible eye irritation are classified in Category 2 (irritating to eyes) 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.
Today a validated methods and procedures protocol about the Bovine Eye assay is available. The differences between the present test and the validated protocol are not suspected of impairing the results. Therefore, it can be concluded that the substance is not irritating, based on the BE assay. This result is confirmed by the supporting study in which the mean values from gradings at 24, 48 and 72 hours for both rinsed and unrinsed eyes were lower than 1 for corneal opacity, lower than 1 for iritis, lower than 2 for both conjunctival redness and oedema, in all animals.
The available experimental data are adequate for classification and labelling and the results show that the substance is not classified for eye and skin irritation, according to the CLP Regulation (EC 1272/2008).
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