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PBT assessment

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PBT assessment: overall result

Reference
Name:
Reactive Blue 050
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

1.Persistence Assessment:

Based on experimental data the test substance FAT 40069 can be concluded to be not readily biodegradable and stable in the environment. The BOD5/COD ratio was <0.5 from available studies, indicating no rapid biodegradation is likely to take place.

2.Bioaccumulation Assessment:

The partition coefficient n-octanol/water of FAT 40069 at 20 °C was calculated based on the individual solubility in water and n-octanol, and determined to be log Pow = -3.51. 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. 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:

The substance is not harmful or toxic upon oral ingestion as demonstrated by acute oral tests. Also, no acute systemic toxicity was observed when the substance was applied to the skin or the mucosa of animals for tests on skin and eye irritation and skin sensitisation. There is no evidence of chronic toxicity from the available combined repeated dose and reprotoxicity/developmental screening study (OECD 422). Based upon the results obtained in this study, the "no-observed-adverse-effect level" of FAT 40061 is 1000 mg/kg body weight for male and female rats when administered orally by gavage. The substance is not classified as carcinogenic, mutagenic or reprotoxic according to Regulation EC 1271/2008. No long-term studies for marine or freshwater organisms are available. 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: Aquatic toxicity studies in fish, invertebrates, algae and microorganisms were performed according to standard guidelines to evaluate the toxicity potential of the test substance the test substance. Aquatic toxicity studies in fish were performed and the LC50 value noted at the end of 96-hour exposure period to the test substance was 570 mg/L. Toxicity to daphnids showed a 48-hour EC50 value of >180 mg/l and toxicity on algae was also found to be >100 mg/L. Based on the test data for all the three trophic levels (LC50 and EC50 >100 mg/L) FAT 40061 can be classified as 'not toxic' to aquatic organisms.

Based on the above discussion, Reactive Blue 050 can be considered to be persistent, however, it does not fulfil the criteria for bioaccumulation and toxicity, hence it is neither considered to be PBT nor vPvB.