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PBT assessment

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PBT assessment: overall result

Reference
Name:
Reactive Red 024:1
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Reactive Red 024:1
PBT status:
the substance is not PBT / vPvB
Justification:

1.Persistence Assessment:

Based on experimental data FAT 40034 can be concluded to be not-biodegradable and stable in the environment. The substance is designed to be used as a dye for diverse textile fabrics. To ensure high performance and quality of the treated fabric, these class of chemicals are designed to be not biodegradable by microorganisms. The substance to be considered as not biodegradable, hydrolytically stable in the pH range 4- 9, and not sensitive to photodegradation. Hence, its concluded that the substance may be Persistent (P) or Very Persistent (vP).

 

2.Bioaccumulation Assessment:

FAT 40034 has a very low Partition coefficient value (-3.52). Due to very low partition coefficient value conducting adsorption and desorption test was considered scientifically not necessary. For the purpose of risk assessment Koc was calculated using EPA tool KOCWIN and value of log Koc -0.613 is considered for 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 is log Pow = -3.52. This value is below the threshold value of log Kow ≤4.5. Hence, 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 oral dose toxicity study is in rats. The acute oral LD50 of FAT 40147 in rats of both sexes observed over a period of 14 days is greater than 2000 mg/kg bw. Based on the results obtained in the 28-day repeated toxicity study (Read across substance FAT 40850) by gavage, the NOAEL was determined to be 300 mg/kg bw. 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. 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. The substance was tested for all three trophic levels in the aquatic environment (fish, invertebrate and aquatic plants) using acute test design and the lowest effect concentration is found to be LC/ EC50 >100 mg/L. Hence, it can be concluded that the substance does not fulfil the criteria as a toxicant (T).

Based on the above discussion, it is clear that FAT 40034 (Reactive Red 024:1) is neither PBT nor vPvB.

Likely routes of exposure:

Water: the substance is mobile and has low Kow and vapour pressure and high water solubility., via human (oral & dermal).