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EC number: -
CAS number: -
In the Daphnia study, the semi-static design with change of media every
24 hours was predicted to be fully acceptable based on the stability
study. The study was run as a limit test run at 100 mg/L. The end
concentrations noted following analysis were unexpectedly below the 80%
cut-off specified in the OECD guidance. However, the
EC50 is stated as > 100 mg/L, as no effects were seen in this study. In
addition, the test was performed in a semi static system and the
degradation products of the main compound are compounds which are
necessary for the proper use of the dye and are very similar in
structure as can be seen from the results obtained in the hydrolysis
study (see Section 184.108.40.206 and Chapter 5.1.2 of the dossier).
In the algae study, the calculated endpoints for the effect of REACTIVE
ORANGE F08-0314 were the following:
ErC50 > 100 mg/l (95 % conf. limits - 114.6 – 1681.2)
EyC50 > 100 mg/l (95 % conf. limits - 48.5 – 280.4)
The results of this experiment showed that the majority of the observed
inhibition effect was related to the light absorption by the test item.
However, a greater inhibition was seen at 72 hours when the Test Item
REACTIVE ORANGE F08-0314 was in contact with the algae cells. This
indicates that there was also a slight toxic effect on the growth of the
alga (Pseudokirchneriella subcapitata). The substance is not considered
harmful to algae on the basis of the results observed.
The 96h-LC50 of the test substance to Zebra fish (Brachydanio rerio) was
greater than the geometric mean of the actual concentration of 133.6
mg/L test substance solution.
The substance is therefore proposed to be “not classified”.
The environmental studies conducted on the substance have all been
ranked reliability 1 according to the Klimisch et al system. This
ranking was deemed appropriate because the studies were conducted to GLP
and in compliance with agreed protocols. Sufficient dose ranges and
numbers are detailed; hence it is appropriate for use based on
reliability and animal welfare grounds.
The results triggered no classification under the Dangerous Substance
Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No
classification for environmental effects is therefore required.
The substance is therefore proposed to be “not classified” and
appropriate comments are detailed within Section 2 of the registration
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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