Registration Dossier
Registration Dossier
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Reaction mass of Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[[2-(sulfooxy)Vinyl]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)], trisodium salt and Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)]-, sodium and Cuprate(4-), [4,5-dihydro-4-[[8-hydroxy-7-[[2-hydroxy-5-methoxy-4-[2-(sulfooxy)Ethanol]phenyl]azo]-6-sulfo-2-naphthalenyl]azo]-5-oxo-1-(4-sulfophenyl)-1H-pyrazole-3-carboxylato(6-)], trisodium salt
EC number: 941-883-0 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin sensitising potential in Guinea pig maximisation test.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The substance was tested accordingo to OECD guideline 406 (Guinea pig maximisation test).
Test sample had 52.3 % purity and was identified as one of the main constituents of target substance. As no more analytical information on test sample was available, and considering that the other 2 constituents of target substance were very close to this one, i.e. obtained by hydrolysis of a sulphate group, experimental data was considered as reliable and representaive of target substance.
In the treatment group, 9/10 animals showed a positive skin response after challenge. As the percentage of animals with positive reaction is above the threshold of 60 % responding at 1 % intradermal induction, test substance is considered as potentially able to cause skin sensitisation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Following the definition set out in the CLP Regulation (EC 1272/2008), a skin sensitiser is a substance that will lead to an allergic response following skin contact. According to Table 3.4.3, the sub-category 1A for the maximisation test is assigned when the response is ≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose.
The test was conducted with an intradermal injection and a dermal application of 1 % and 25 % of test material, respectively. The allergic response was seen in 90 % of treated animals. Thus, the substance was considered as capable to induce allergic response and was classified as Skin Sensitiser cat. 1A (H317: may cause an allergic skin reaction).
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