Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Reference
Name:
Acid Blue 225
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Acid Blue 225
PBT status:
the substance is not PBT / vPvB
Justification:

1. Persistence Assessment:


Based on experimental data the test substance FAT 21036 can be concluded to be not-biodegradable and stable in the environment. A hydrolytic stability test, performed as a function of pH in aqueous solution according to OECD guideline 111 method C.7(440/2008) concluded that substance the FAT 21036 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 partition coefficient n-octanol/water of FAT 21036 at 20 °C was calculated based on the individual solubility in water and n-octanol, and determined to be log Pow = 0.58. 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 = 0.58. 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 read across (FAT 20297) oral repeated dose toxicity study is in rats (OECD 407). Based upon the results obtained in this study, the "no-observed-effect level" of FAT 21036 is 282 mg/kg body weight for 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. 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 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 68.49 mg/L. Toxicity to daphnids showed 48-hour EC50 value of >100 mg/l and toxicity on algae was also found to be >100 mg/L. For microorganisms, studies conducted using actvated sludge from a domestic wastewater treatment plant reported an 3 h IC50 of >400 mg/L. Based on the test data for all the three trophic levels (with the most sensitive endpoint LC50 for fish being 68.49 mg/L) FAT 21036 can be classified as 'toxic' to aquatic organisms according to GHS but the T-criterion is not fulfilled according to the screening criteria provided by ECHA.