Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

1.Persistence Assessment:

The substance is not readily biodegradable according to biodegradation tests conducted. Data on the biodegradation in the sediment and soil compartments are lacking. The test item hence should be considered as not biodegradable. The substance is hydrolytically stable under basic, neutral and acidic environmental conditions. Photodegradation in air is not a relevant degradation process for this substance since the test item 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, it cannot be excluded that the substance should be regarded as persistent (P) in the environment or 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 fulfill the B and the vB criterion if its log Kow ≤ 4.5. The octanol-water partition coefficient for the test item is log Kow < -6.29. This value is 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:

No long-term studies for marine or freshwater organisms are available. Therefore, based on current knowledge, the substance does not fulfill 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 fulfill 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 >1000 mg/L,

• Short term toxicity to aquatic invertebrates: EC50 >180 mg/L,

• Short term toxicity to freshwater plant: EC50 >100 mg/L.

• Short term toxicity to freshwater plant: NOEC = 3.2 mg/L.

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

The substance is neither classified as carcinogenic, mutagenic or toxic for reproduction.

There is no evidence of chronic toxicity from the available 28-day repeated dose toxicity test. No sub-chronic or chronic repeated dose toxicity studies are available.

In conclusion, the available data on toxicology and ecotoxicology give no evidence of significant toxicity and it is regarded as unlikely that the substance fulfills the T criterion on the basis of the available data.

Likely routes of exposure:

Via water and (oral & dermal)