Registration Dossier
Registration Dossier
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EC number: 700-422-1 | CAS number: 61320-65-8
Endpoint summary
Administrative data
Description of key information
Diazokomponente Rot B show no corrosive property and is considered to have no skin irritation category.
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)
Additional information
SKIN CORROSION
An in-vitro study for predicting non-specific, corrosive potential of Diazokomponente Rot B by using reconstructed human skin (RHS) EST-1000 in accordance with OECD TG 431 and with an EC guideline (amending Concil Direcrive 67/548/EEC B 40 Skin corrosion). Diazokomponente Rot B was tested undissolved (25 mg per insert, plus 50 µl 0.9 % NaCl to moisten and to ensure good contact with the skin) and an incubation time of 3 min or of 60 min was used to determine time related toxic effects. After incubation the MTT reduction assay was performed to measure the cell viability which was 95 % and 98 % , respectively. Thus, the results show that no corrosive property of the test inem was determined by the assay used (Bayer AG 2011)
SKIN IRRITATION
This study which allows the hazard identification of irritant substances in accordance with UN GHS category 2, was performed in 2011.
The experiment was carried out according to OECD 439 and EU Test Method B.46 using commercially available reconstructed human epidermis (RHS) model EST-1000 (CellSystems, St.Katharinen, Germany).
Undissolved Diazokomponente Rot B was applied topically to the RHS model, i.e. 30 mg per insert (plus 30µl 0.9% NaCl to moisten and ensure good contact with the skin; three replicates). After an exposure period of 20 minutes, followed by a 42 hours post-treatment incubation period, the cell viability was measured to be 91 % (rounded) in the MTT (Methylthiazoletetrazolium) conversion assay. The results of the concurrent negative control (NC, 0.9% NaCl) and positive control (PC, 5% SDS) demonstrated the viability (NC) and sensitivity (PC) of the test model. Thus, the results show that Diazokomponente Rot B is considered to have no skin irritation category. (Bayer AG 2011).
EYE IRRITATION
This in vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model was performed in 2011. The model used is standardized and commercially available (SkinEthicTM Human Corneal Epithelial Model (HCE); SkinEthic, France).
Undisolved Diazokomponente Rot B was applied topically to the HCE tissue, i.e. 30 mg per insert (three replicates). After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 99.14% as measured by a MTT conversion assay.
The results of the concurrent negative (NC, PBS) and positive control
(PC, 1H-1,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the test model.
The results show that Diazokomponente Rot B is predicted as non-irritant under the conditions of this test method (Bayer 2011).
.Justification for classification or non-classification
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