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PBT assessment

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PBT assessment: overall result

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Name:
Reactive Yellow 095
Type of composition:
legal entity composition of the substance
Reference substance:
Reactive Yellow 095
Reference substance:
Reactive Yellow 095
Name:
Reactive Yellow 095
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Reactive Yellow 095
Reference substance:
Reactive Yellow 095
PBT status:
the substance is not PBT / vPvB
Justification:

1.Persistence Assessment:

Based on experimental data the test substance FAT 40000 can be concluded to be not-biodegradable and stable in the environment. The test material 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 test 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 test substance FAT 40000 is hydrolytically stable, i.e., a half-life of greater than 1 year at 25 °C, at pH 4, 7 and 9.

 

2.Bioaccumulation Assessment:

The test substance FAT 40000 has a very low Partition coefficient value (-5.70). Due to very low Partition coefficient value conducting Adsorption and Desorption test was considered a scientifically not necessary. For the purpose of risk assessment Koc was calculated using EPA tool ECOSAR and value of 0.425 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 = 0.425

This value is much below the threshold value of log Kow ≤ 4.5. Considering the low water solubility value and further looking at the influence of lipid solubility on the bioconcentration of hydrophobic compounds and demonstrated a decrease in lipid solubility with increasing Kow values (Chessells et al. (1992)) for superhydrophobic compounds (log Kow >6), it can be assumed that it will led to reduced BCFs. 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 oral dose toxicity study is in rats. The acute oral LD50 of FAT 40000/G 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 40277) by gavage, the NOAEL was determined to be 200 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. For the substance under consideration, the following EC50/L50 values were obtained: Aquatic toxicity studies in fish, invertebrates, algae and microorganisms were performed as per standard guidelines to evaluate the toxicity potential of the test substance the test substance and the EC50/ LC50 value was found to be >100 mg/L.

 

For microorganisms, studies conducted using activated sludge from a domestic wastewater treatment plant reported an 3 h IC50 of >320 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 in Lemna (7 day EC50 >100 mg/L) .

The substance is considered non-biodegradable and hence will be not-classified for aquatic toxicity hazards according to CLP.

Likely routes of exposure:

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