Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
no hazard identified

Marine water

Hazard assessment conclusion:
no hazard identified

STP

Hazard assessment conclusion:
no hazard identified

Sediment (freshwater)

Hazard assessment conclusion:
no hazard identified

Sediment (marine water)

Hazard assessment conclusion:
no hazard identified

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
no hazard identified

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

General discussion

 

In the Daphnia study with the structural analogue, 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.

In the algae study, the calculated endpoints for the effect of the structural analogue 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 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.

In the 96 -hours static toxicity test in Zebrafish (Brachydanio rerio) with Reactive Orange 107, concentrations of 1, 10, 100, and 500 mg/L were used. A 100% survival rate was observed in control fish, and a 100% survival rate was observed in fish treated with the test substance up to 500 mg/L. Based on observation, the 96- hour median lethal concentration (LC50) of the test substance was determined to be > 500 mg/L. The NOEC was determined to be 500 mg/L.

 

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 or 2 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted in compliance with agreed protocols and/or GLP. 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.