Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: - | 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
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 0.1 mg/L
- Assessment factor:
- 1 000
- Extrapolation method:
- assessment factor
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.01 mg/L
- Assessment factor:
- 10 000
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 10 mg/L
- Assessment factor:
- 100
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 0.085 mg/kg sediment dw
- Extrapolation method:
- sensitivity distribution
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.009 mg/kg sediment dw
- Extrapolation method:
- sensitivity distribution
Hazard for air
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 0.018 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 2.08 mg/kg food
- Assessment factor:
- 300
Additional information
General discussion
In the Daphnia study, the semi-static design with change of media every 24 hours was predicted to be fully acceptable based on the stability study. The study was run as a limit test run at 100 mg/L. The end concentrations noted following analysis were unexpectedly below the 80% cut-off specified in the OECD guidance. However, the EC50 is stated as > 100 mg/L, as no effects were seen in this study. In addition, the test was performed in a semi static system and the degradation products of the main compound are compounds which are necessary for the proper use of the dye and are very similar in structure as can be seen from the results obtained in the hydrolysis study (see Section 4.1.1.1 and Chapter 5.1.2 of the dossier).
In the algae study, the endpoints for the effect of REACTIVE RED F08-0146 were the following:
ErC50 > 200 mg/l (nominal)
EyC50 > 200 mg/l (nominal)
The results of this experiment showed that the majority of the observed inhibition effect was related to the light absorption by the test item. However, a slight inhibition was seen at 200 and 100 mg/L, when REACTIVE RED F08-0146 was in contact with the algae cells for 72 hours. This indicates that there was also a slight toxic effect on the growth of the alga (Pseudokirchneriella subcapitata).
An acute fish toxicity test of Reactive Red F08 -0146 was conducted according to OECD Guidelines for the Testing of Chemicals, 203 Fish Acute Toxicity Test. There were no effects on fish in this study. The 96h-LC50 of the test substance to Zebra fish (Brachydanio rerio) was greater than the nominal concentration of 120 mg/L test substance solution and the 96h-NOEC was the nominal concentration of 120 mg/L test substance solution.
During the test, the actual concentration of the main constituent could not be maintained within 80%-120% of the nominal concentration of the main constituent (86.4mg/L), however, the nominal values for the LC50 and the NOEC were used to determine classification for the following reasons:
• Reactive dyes do not historically cause toxicity to fish and no effects on fish were observed in this study.
• The lower than expected geometric mean value noted in this study is probably due to hydrolysis of Reactive Red F08-0146 under test conditions therefore it is not an accurate value. The results of the hydrolysis study (see Section 4.1.1.1) shows that Reactive Red F08-0146 undergoes significant hydrolysis at neutral pH. The results of this study indicate that the hydrolysis products of the test substance do not appear to harm fish.
The substance is therefore proposed to be “not classified”.
Conclusion on classification
The environmental studies conducted on the substance have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds.
The results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for environmental effects is therefore required.
The substance is therefore proposed to be “not classified” and appropriate comments are detailed within Section 2 of the registration dossier.
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.