Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
Reaction mass of Tetrasodium 2-[{4-[{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfonatonaphthalen-1-yl}diazenyl]-7-sulfonatonaphthalen-1-yl}diazenyl]benzene-1,4-disulfonate and Tetrasodium 2-[{4-[{4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfonatonaphthalen-1-yl}diazenyl]-6-sulfonatonaphthalen-1-yl}diazenyl]benzene-1,4-disulfonate
EC number: 916-837-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
1. Persistence Assessment:
Based on experimental data the test substance FAT 40032 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 the test substance FAT 40032 to be hydrolytically stable, i.e., a half-life of greater than 1 year at 25 °C, at pH 7 and 9, whereas at pH 4 the estimated rate constant was 1.46 X 10 -6 with half-life of 198 days.
2. Bioaccumulation Assessment:
The adsorption/desorption screening test does not have to be conducted as FAT 40032 has a low octanol water partition coefficient (log Pow -5.57). Log Kow calculated using EPA ECOSAR is 3.126. 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 = 3.126. 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, whereas the test substance was found to be skin sensitizer. There is no evidence of chronic toxicity from the available read across (FAT 40827) 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 40032 is 1000 mg/kg body weight for 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 fulfil 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 must 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. 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. For all the three tropic levels (fish, invertebrates and aquatic plants) EC50/LC50 >100 mg/L. For microorganisms, studies conducted using activated 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 FAT 40032 can be classified as 'not-toxic' to aquatic organisms according to GHS and the T-criterion is not fulfilled according to the screening criteria provided by ECHA.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
