Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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.
EC number: 201-353-5 | CAS number: 81-48-1
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- yes
- Remarks:
- see 'Principles of method if other than guideline'
- Principles of method if other than guideline:
- However, a preliminary range-finding test had identified the test substance to be of low toxicity (ie. the 96 hour LC50 was estimated as > 500 mg/L). The test substances which were of low toxicity were tested using a limit test at a concentration of 500 mg/L. A stock of 10 g/L was prepared and triplicate test concentrations prepared by adding 500 mL of stock to 9.5 litres of dilution water.
There were three other deviations from the general procedures. Firstly, the fish were transferred directly from their stock tank into the test solutions. Secondly, the temperature range during the holding/acclimation period was 12.9 to 16.3 °C and during the test ranged from 13.2 to 15.0°C. A third deviation was that the test concentrations were prepared and tested as "water-accommodated fractions" of Serip]as Blue 5RLN-TP. The procedures follow the OECD Guidelines for the Testing of Chemicals: Fish Acute toxicity Test Ref.203
The measured temperatures in the test tanks were outside the standard range of 14 to 16 °C during the test and ranged from 13.2 to 15.0 °C. However, this was not considered likely to have significantly affected the response of the fish. - GLP compliance:
- yes
- Specific details on test material used for the study:
- - Purity not specified
- Chemical name: Seriplas Blue 5RLN-TP
- Binnie Environmental Ref.: 039418
- Supplied by: Yorkshire Chemicals plc
- Date of receipt: 10.03.1994
- Storage: Cool conditions
- Appearance: dull blue powder
- Odour: None
- Solubility in water: Insoluble - Analytical monitoring:
- no
- Details on sampling:
- Effluents are stored at temperatures below 15 °C and are tested as soon after receipt as is practically possible.
- Vehicle:
- no
- Details on test solutions:
- A stock of 10 g/L was prepared and triplicate test concentrations prepared by adding 500 mL of stock to 9.5 litres of dilution water.
Preparation of Test Solutions
In cases where the test suhstance is soluble in water. each test solution is prepared by direct addition of the reyquired amount of test substance lo the dilution water. In cases where the substance has limited solubility then one of the following methods is used in order to maintain an adequate level of dispersion throughout the test period:
(i) acetone/methanol is used to disperse the test substance
(ii) a benign dispersing/emulsifying agent is used
(iii) the sample is dispersed by mechanical or other suitable apparatus, shielded from the test animals.
The method chosen depends upon the conccntrntion levels of the test substance required, and the reasons for a particular choice are discussed in the main body of the report. - Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- - Supplier: Upwey Trout Farm, Weymouth, Dorset
- Date of arrival at laboratory: 1994-03-09
- Holding/ Acclimation period: 1994-03-09/1994-03-28
- Acclimation conditions: 12.9-16.3 °C; Dissolved oxygen: > 80% air saturation value
- Food: diet of Trout Fry feed (BP Nutrition (U.K.) Limited)
- Keeping water: dechlorinated mains water
- Mean length of fish: 51.6 mm
- Mean weight of fish: 1.18 g
- The sizes of the animals were found to be in approximately normal (Gaussian) distribution
The rainhow trout are examined prior to selection for the test to ensure that only heatlthy animals are exposed. Following the completion of the test a randum sample of 10 animals is measured and weighed, and the results plotted on a linear/prohit scale in order to check that they are in an approximately normal distribution.
The animals are held in the lahoratory for at least twelve days befrore the start of the test and they are fed on a diet of Trout Fry feed manufactured hy BP Nutrition (U.K.) Limited. Their environment is dechlorinated main water and the concentration of dissolved oxygen is maintained close to saturation by continuously diffusing air through the water. - Test type:
- semi-static
- Water media type:
- freshwater
- Remarks:
- dechlorinated mains water of typical hardness 240 mg calcium carbonate per liter
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Hardness:
- 13.4 °dH = 240 mg/L CaCO3 (confirmed analytically by titration with EDTA solution.
- Test temperature:
- 13.2 - 15.0 °C
- pH:
- 7.6 - 8.5
- Dissolved oxygen:
- 91-100 % ASV (air saturation value)
- Nominal and measured concentrations:
- Water Accommodated Fraction (WAF) was used to test effects at effective loading of 500 mg/L because the substance is insoluble in water.
- Details on test conditions:
- - Test vessels: plastic aquaria with a working volume of 10 litre
- Experimental design: 1 test concentration plus 1 control
- Number of fish: 10 per test concentration
- Feeding during exposure: None
- Method of initiation: fish were placed in prepared media
- Loading: 1.18 g (+/-0.21) body weight
- Photoperiod: 16 h light : 8 h dark
- Temperature: 14 - 16 °C
- Aeration: gentle aeration
- Test concentration/s: 500 mg/L
- Replicates: 3 (test concentration), 1 (control)
- Method of administration: direct weighing
- Medium renewal: daily
- Monitoring data: pH, dissolved oxygen and temperature were measured and recorded daily
- Criteria of effects: absence of response to physical stimulation; in addition to observations on mortality the first 6 hours and thereafter at 24, 48, 72 and 96 hours, type and incidence of sub-lethal effects compared with control fish were observed - Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 500 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- The measured temperatures in the test tanks were outside the standard range of 14 to 16 °C during the test and ranged from 13.2 to 15.0 °C. However, this was not considered likely to have significantly affected the response of the fish.
- Sublethal observations / clinical signs:
Test substances identified by preliminary studies as being of low toxicity (ie. where the 96 hour LC50 > 500 mg/L) are typically assessed further by using a limit test at a concentration of 500 mg/L. To determine effects accurately, limit tests use three test vessels each containing ten fish at the single test substance concentration. The study reported here resulted in no mortalities for thirty fish exposed to a 500 mg/L concentration of Solvent Violet 13. The limit test therefore confirmed the preliminary test results that the 96 hour LC,0 was greater than 500 mg/L of Solvent Violet 13.
Solvent Violet 13 is described by Yorkshire Chemicals' Product Safety Data Sheet as "insoluble" in water. The test concentrations reported in this study can therefore only be described as "water-accommodated fractions". However, the data reported would give a true reflection of the aquatic tnxicity of Solvent Violet 13 and can be considered an
environmentally realistic testing approach since it reflects what would happen to a sensitive fish species if the test substance were to enter or contaminate a body of freshwater.
The measured temperatures in the test tanks were outside the standard range of 14 to 16°C during the test and ranged from 13.2 to 15 .0°C. However, this was not considered likely to have significantly affected the response of the fish.
- Validity criteria fulfilled:
- yes
- Remarks:
- mortality in the controls < 10% by the end of the test; dissolved oxygen concentration above 60% of the air-saturation value throughout the exposure period; pH did not vary by more than 1 unit
- Conclusions:
- The acute toxicity of Solvent Violet 13 to fish was conducted in a static test according to the OECD Guideline 203. After 96 hours of exposure a LC50 value of higher than 500 mg/L was obtained.
- Executive summary:
The objective of the test is lo determine the 96 hour median lethal concentration (96 huur LCw) of Solvent Violet 13 to rainbow trout (Oncorhynchus mykiss).
The test was carried out in accordance with OECD Guideline 203, 'Fish Acute Toxicity Test'. A preliminary range-finding test had identified the Solvent Violet 13 to be of low toxicity (ie. the 96 hour LC50 was estimated as > 500 mg/L). Therefore the main test was carried out under semi static conditions at a limit test concentration of 500 mg/L. A stock of 10 g/L was prepared and triplicate test concentrations prepared by adding 500 mL of stock to 9.5 litres of dilution water. The fish were transferred directly from their stock tank into the test solutions and the temperature range during the holding/acclimation period was 12.9 to 16.3°C and during the test ranged from 13.2 to 15.0 °C. Observations were made on the number of dead fish and the incidence of sub-lethal effects after 6, 24, and 96 hours of exposure. After 96 hours no toxic effects of Solvent Violet 13 against fish were observed at 500 mg/L. This toxicity study is classified as acceptable and satisfies the guideline requirements for the acute fish study.
Reference
Description of key information
The test was carried out in accordance with OECD Guideline 203, 'Fish Acute Toxicity Test'. The main test was carried out under semi static conditions at a limit test concentration of 500 mg/L. A stock of 10 g/L was prepared and triplicate test concentrations prepared by adding 500 mL of stock to 9.5 litres of dilution water. The fish were transferred directly from their stock tank into the test solutions and the temperature range during the holding/acclimation period was 12.9 to 16.3°C and during the test ranged from 13.2 to 15.0 °C. Observations were made on the number of dead fish and the incidence of sub-lethal effects after 6, 24, and 96 hours of exposure. After 96 hours no toxic effects of Solvent Violet 13 against fish were observed at 500 mg/L.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 500 mg/L
Additional information
"Should read: > 500 mg/L"
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.