Registration Dossier
Registration Dossier
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Reaction mass of isomers disodium 8-(2-{4-[benzyl(ethyl)amino]-2-methylphenyl}diazen-1-yl)-5-(2-{2,5-dimethyl-4-[2-(3-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl)naphthalene-2-sulfonate, disodium 5-(2-{4-[benzyl(ethyl)amino]-2-methylphenyl}diazen-1-yl)-8-(2-{2,5-dimethyl-4-[2-(3-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl)naphthalene-2-sulfonate
EC number: 700-946-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
non skin irritant
non eye 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
Skin irritation
The in vitro study was performed in order to evaluate the potential of the test item to evoke skin irritation in a reconstructed human epidermis (RhE) test method. The test procedure was performed following the EU-Method B.46 and the OECD 439. In the in vitro skin irritation test using the EpiSkin human epidermis model 10 mg test item + 15 µL A. dest. were applied topically for 15 minutes. After 42 h post-incubation cytotoxic effects were determined via MTT reduction assay. The test item showed purple/black colouring in concact with MTT medium. Therefore, killed tissues were treated with the test item to determine Non-Specific MTT reduction. The NSMT-corrected mean relative tissue viability (% negative control) was > 50%. Therefore, the test item is considered non-irritant to skin in the Reconstructed human Epidermis (RhE) Test Method.
A skin irritation in vivo test is also available. The test was performed according to OECD Guideline 404 and EU Method B.4. Under the conditions of the present study, the single dermal application of the test item to three rabbits at a dose of 0.5 g showed neither irritant nor corrosive effects. Neither mortalities nor significant clinical signs of toxicity were observed. In conclusion, the test item is considered non-irritant to skin.
Eye irritation
The evaluation of the test item in the Bovine Corneal Opacity and Permeability (BCOP) Test Method was performed following following OECD Guideline 437. The test item was suspended with physiological saline 0.9% NaCl to gain a 20% concentration. The mean in vitro irritation score was calculated to be 10.78. According to OECD Guideline no. 437 (Oct. 2017), a substance with an IVIS > 3 and ≤ 55 induces effects on the cornea, that cannot be classified in an UN GHS Category for eye damage with the BCOP study only. In this case no prediction can be made.
The eye irritation of the substance is evaluated according to OECD 405. After the application into the eyes of three male NZW rabbits the test item produced slightly irritant but no corrosive ocular effects in all animals, which were fully reversible within 4 days in animal no. 1, within 9 days in animal no. 2 and within 6 days in animal no. 3 post application. Neither mortalities nor significant clinical signs of toxicity were observed.
Upon fluorescein examinations at the end of the observation period of 72 hours and at the end of the prolonged observation period no corneal lesions were found in any animal. Conjunctival redness, chemosis, discharge were observed in all animals. Under the conditions of the present study, a single ocular application of the test item to rabbits at a dose of 0.1 g produced slightly irritant effects, which were fully reversible within up to 9 days. Neither mortalities nor significant clinical signs of toxicity were observed. According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for eye irritation.
Justification for classification or non-classification
Skin irritation
Based on the in vitro results and on the OECD 439 criteria, the test item is not classified for skin irritantion as per the CLP Regulation (EC) No 1272/2008.
Eye Hazard Potential
Considering the results obtained in the OECD 405, the substance is not classified as eye irritant as per the CLP Regulation (EC) No. 1272/2008.
In conclusion, the substance is not classified for the eye/skin irritation, according to the CLP Regulation (EC 1272/2008).
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