2-[(8-amino-7-{[4-substituted-2-sulfonatophenyl]diazenyl}-1-hydroxy-3,6-disulfonaphthalen-2-yl)diazenyl]-4-[(4-chloro-6-{[3-(substituted)phenyl](ethyl)amino}-heteromonocycl-2-yl)amino]arylsulfonic acid, potassium and sodium salts

Endpoint summary

Additional information

1. Persistence Assessment

The substance is not readily or inherently biodegradable according to two valid GLP biodegradation tests that were carried following the respective EU Methods. Data on the biodegradation in the sediment and soil compartments are lacking. FAT 40849/A TE hence should be considered as not biodegradable. The substance is hydrolytically stable under neutral and basic environmental condition but shows a tendency for less stability in acidic environments. Photodegradation in air is not a relevant degradation process for this substance since FAT 40849/A TE has negligible vapour pressure and atmospheric release in form of fumes or aerosols is unlikely with regard to the identified use patterns. There is no information available about photodegradation of the substance in sediment or soil.

In conclusion, the substance should be regarded as persistent (P) in the environment or even very persistent (vP) in the environment.

2. Bioaccumulation Assessment

According to the screening criteria for bioaccumulation (B for bioaccumulative, vB for very bioaccumulative) given in the technical guidance provided by ECHA (ECHA 2008, Guidance on information requirements and chemical safety assessment, Chapter R.11), a substance does not fulfil the B and the vB criterion if its log KOW ≤ 4.5. The octanol-water partition coefficient for the test item was estimated from its solubility in n-octanol and in water to be log KOW < -3.2. This value lies much below the threshold value of log KOW ≤ 4.5.

In conclusion, the substance is regarded as not bioaccumulative neither fulfilling the B nor the vB criterion.

3. Toxicity Assessment

The substance is neither classified as carcinogenic, mutagenic or toxic for reproduction and there is no other evidence of chronic toxicity from the available 28-day repeated dose mammalian toxicity test. No sub-chronic or chronic repeated dose toxicity studies are available. No long-term studies for marine or freshwater organisms are available. Therefore, it can not be excluded that the substance fulfils the T criterion based on the PBT criteria according to Annex XIII of the REACH regulation.

According to the screening criteria provided by ECHA (ECHA 2008, Guidance on information requirements and chemical safety assessment, Chapter R.11), a substance has to be considered to fulfil the criteria for toxicity (T for toxicity) if the EC50 or LC50 of a short-term aquatic toxicity test is below 0.1 mg/L. For the substance under consideration, the following EC50/L50 values were obtained:

• Short term toxicity to fish: LC50>50 mg/L,

• Short term toxicity to aquatic invertebrates: EC50=100 mg/L,

• Short term toxicity to aquatic algae: EC50=35 mg/L.

These values lie much above the threshold value of 0.1 mg/L and do therefore not indicate that the substance fulfils the T criterion.

In conclusion, the available data on toxicology and ecotoxicology give no evidence of significant toxicity and it is regarded as unlikely that FAT 40849/A TE fulfils the T criterion on the basis of the available data.

4. Summary and overall Conclusions on PBT or vPvB Properties

The substance FAT 40849/A TE should be considered as persistent in the environment. It has no potential for bioaccumulation. The available toxicological and ecotoxicological data do not give evidence of significant toxic effects of the substance. FAT 40849/A TE is fulfilling the P or even the vP criterion, but not the B or vB and T criteria according to Annex XIII of the REACH regulation. The substance is not a PBT or vPvB substance according to the REACH regulation.

2. Emission Characterisation

No emission characterisation is required since FAT 40849/A TE is not a PBT or vPvB substance.