Registration Dossier
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Reaction mass of potassium, sodium 2-[(E)-(2,4-diamino-6-carboxy-3-[(E)-(4-{[2-(sulfonatooxy)ethyl] sulfonyl}phenyl)diazenyl]-5-{(E)-phenyldiazenyl}phenyl)diazenyl]benzenesulfonate (1:5.8:3.4), polyvinylsulfonyl and potassium, sodium 2-[(E)-{2,4-diamino-6-carboxy-3,5-bis[(E)-(4-{[2- (sulfonatooxy)ethyl]sulfonyl} phenyl)diazenyl]phenyl}diazenyl]-benzenesulfonate (1:5.8:2.4), vinylsulfonyl- and potassium, sodium 2-[(E)-(2,4-diamino-6-carboxy-5-[(E)-(4-{[2-(sulfonatooxy)ethyl] sulfonyl}phenyl)diazenyl]-3-{(E)-phenyl]diazenyl}phenyl)diazenyl]-benzenesulfonate (1:5.8:3.4), polyvinylsulfonyl- and potassium, sodium 2-[(E)-(2,4-diamino-6-carboxy-3,5-bis{(E)- phenyldiazenyl}phenyl)diazenyl]-benzenesulfonate (1:5.8:6.8), polyvinylsulfonyl
EC number: - | CAS number: -
Endpoint summary
Administrative data
Description of key information
In an in vivo skin irritation study performed according to OECD 404 and GLP principles, the substance was not irritating.
In an in vivo eye irritation study performed according to OECD 405 and GLP principles, the substance was not 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
Skin irritation/corrosion
In an in vitro skin corrosion test performed according to OECD 431 the test substance was found to be not corrosive.
In a subsequent test in rabbits performed according to OECD 404 FAT 40854/A TE was not irritating.
Eye irritation/corrosion
In an in vitro eye irritation test (BCOP) performed according to OECD 437 the test substance was found to be not irritating.
In a subsequent test in rabbits performed according to OECD 405 FAT 40854/A TE showed irritation of the conjunctivae, consisting of redness, chemosis and discharge, that had resolved within 48 hours. Staining of the sclera resolved within 14 days after instillation. FAT 40854/A TE was concluded to be not irritating.
Justification for selection of skin irritation / corrosion endpoint:
Reliable in vivo study performed according to guideline.
Justification for selection of eye irritation endpoint:
Reliable in vivo study performed according to guideline.
Justification for classification or non-classification
Based on the results above, FAT 40854/A TE does not have to be classified for irritation/corrosion according to
the:
-Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2011),
-Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
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