Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
skin irritation, in vivo: irritant
eye irritation, in vitro: corrosive
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Target substance is a multi-constituent substance. The 2 constituents differ by a methyl group.
No data on skin irritation was available on target substance or on constituents; however, data was available on a structural analogue. Analogue substance was tested following internal guidelines for in vivo skin irritation. High score erythema (ca. 4) was observed.
The potential for eye irritation was tested in vitro on constituent 1 of target substance following OECD 437. Discolouration of the corneas was observed which did not allow to measure corneal opacity.
Details on the read-across are available in section 13.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), a substance is classified as producing irreversible effects on the eye/serious damage to eyes (Category 1) when, in studies performed on animals, cornea lesions and other severe reactions (e.g., destruction of cornea) observed at any time during the test, as well as persistent corneal opacity, discoloration of the cornea by a dye substance, adhesion, pannus, and interference with the function of the iris or other effects that impair sight are observed. In this context, persistent lesions are considered those which are not fully reversible within an observation period of normally 21 days. The substance was tested in an in-vitro test showing discolouration of the cornea and in a conservative approach the classification used for animal testing is followed, i.e. H318 Category 1.
According to the CLP Regulation (EC 1272/2008), a substance is classified as skin irritant cat 2 when:
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.
Based on the test results (erythema ca. 4, edema 1.8 -2.3), test substance is classified as H315 Category 2.
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