Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Disperse Violet 057
Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
Disperse Violet 057
PBT status:
the substance is not PBT / vPvB

Persistence assesment

Over several studies, the biological oxygen demand (BOD5) and chemical oxygen demand (COD) values for FAT 36038 were determined. The BOD5/COD quotient was found to be less than 0.5 in each case, therefore, the substance is considered to be not indicative of rapid degradation. Thus, fulfiling the presistence (P) criteria. However, it was found to be hydrolytically unstable, hence the very persistent (vP) nature is ruled out.


Bioaccumulative assesment

Disperse Violet 057 was found to have log Pow of 5.02, which indicates some potential to bioaccumulate. However, the bioaccumulation potential of Disperse Violet 057 was discussed in the "Screening Assessment" by Environment Cananda and assessed it to be not bioaccumulating, based on the following evidence:

-Hu and Shen 2008, evaluated the bioconcentration of a structurally similar dye, Disperse Blue 077 in Zebra fish (Brachydanio rerio) in a 28-day semi-static test with a test medium renewal every two days. Lack of detection in fish extracts (<0.02 mg/L) in this study suggested a limited solubility in lipids and/or limited potential to partition into fish tissue from aqueous systemsmore likely both. The bioconcentration factor (BCF) was estimated to be <100.

-Several experimental fish bioaccumulation tests for disperse anthraquinone dyes, performed according to test methods specified by the Japanese Ministry of International Trade and Industry (MITI), reported log bioaccumulation factor (BCF) being < 0.7 (BCF < 5), expressed on the basis of wet body weight of the fishes (Anlikeret al. 1981; Anliker and Moser 1987).

-Dimitrov et al. (2005) demonstrated that the increaing cross-sectional diameters may lead to reduction in uptake rate in case of bioaccumulation. The maximum diameter of Disperse Violet 57 and its conformers ranges from 13.7 to 18.9 angstroms (1.37 to 1.89 nm) (BBM 2008) suggesting that a potential for a reduced uptake rate from water and in vivo bioavailability exists with this dye.

Toxicity assesment

The chemical when assessed in a Daphnia magna reproduction test, had a NOEC (reproduction) of 0.06 mg/L, while the EC10 (reproduction) was determined to be 0.01337 mg/L. Short-term toxicity tests are also available for all the three tropic levels (fish, invertebrates, algae and microorganisms). The 48-hour TL50 for fish (Rainbow trout) is 450 mg/L, while the 48-hour EC50 in Daphnia magna is >100 mg/L. A growth inhibition test on Lemna gibba has been performed, where the resulting NOEC and EC50 for growth rate and yield (for frond number and dry weight) on the basis of the nominal concentration of the test item were higher than 100 mg test item/L. Also, in an activated sludge respiration inhibition test a 3-hour IC50 value of >320 mg/L was observed. Based on the results obtained in all tests conducted, the test substance FAT 36038 can be considered as not toxic to aquatic environment.

Disperse Violet 057 was neither found to be a CMR nor there is evidence to suggest chronic toxicity potential in terms of mammalian toxicity.


Taking into consideration all the above arguments, Disperse Violet 057 is neither a PBT nor a vPvB substance.