Registration Dossier

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.1 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.01 mg/L
Assessment factor:
10 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
10 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
0.085 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
0.009 mg/kg sediment dw
Extrapolation method:
sensitivity distribution

Hazard for air

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
0.017 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
PNEC oral
PNEC value:
33.3 mg/kg food
Assessment factor:
300

Additional information

General discussion

 

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 4.1.1.1 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”.

Conclusion on classification

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 dossier.