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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 919-274-6 | 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
Short-term toxicity to fish
Administrative data
- Endpoint:
- short-term toxicity to fish
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 18 October 2007 to 21 December 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- yes
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- yes
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)
- Deviations:
- yes
- Principles of method if other than guideline:
- Some of the test vessels at 24 hours (old media) during the defintive test showed Air Saturation Vale below the 60% stated in the protocol. This deviation was considered not to have affected the outcome of the integrity of the study as ASV values for the remainder of the test were above 60% and the fish showed no sub-lethal affects or mortality over the test period.
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- Sponsor's identification: AS305BD
Description: dark brown, viscous liquid
Lot number: TS07002
Analytical purity: 100%
Storage conditions: room temperature in the dark
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
Not applicable
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- A Strata C8 (500 mg/3 mL) solid phase extraction (SPE) cartridge was sequentially preconditioned with methanol and water·. A volume (500 mL) of test sample was eluted through the cartridge and the cartridge dried. The test material was eluted from the cartridge with methanol (10 mL). Standard solutions were prepared in methanol at a nominal concentration of 5 mg/L.
Water samples were taken from the control and each replicate test vessel at 0 (fresh media), 24 (old media), 72 (fresh media) and 96 hours (old media) for quantitative analysis. Duplicate samples and samples at 24 (fresh media), 48 (fresh and old media) and 72 (old media) were taken and stored at approximately -20°C for further analysis if necessary.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- An amount of test material (2250 mg) was dispersed in 22.5 Iitres of dechlorinated tap water with the aid of propeller stirring at approximately 1500 rpm at a temperature of approximately 14°C for a period of 24 hours. After 24 hours the stirring was stopped and the undissolved test material removed by filtration (0.2 µm Sartopore filter, first approximate 1 litre discarded in order to precondition the filter) to give the 100% v/v saturated solution. This method of preparation was conducted in triplicate to give replicates R1, R2 and R3.
Test organisms
- Test organisms (species):
- Oncorhynchus mykiss (previous name: Salmo gairdneri)
- Details on test organisms:
- TEST ORGANISM
- Common name: rainbow trout
- Source: Brow Well Fisheries Limited, Hebden , Yorkshire, UK
- Age at study initiation (mean and range, SD): not stated
- Length at study initiation (length definition, mean, range and SD): not stated
- Weight at study initiation (mean and range, SD): not stated
- Feeding during test: none
ACCLIMATION
- Acclimation period: 3 December 2007 to 17 December 2007
- Acclimation conditions (same as test or not): yes
- Type and amount of food: commercial trout pellets
- Feeding frequency: not stated
- Health during acclimation (any mortality observed): none
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- None
Test conditions
- Hardness:
- approximately 140 mg/L as CaC03
- Test temperature:
- 14°C to 16°C
- pH:
- 7.6-8.1
- Dissolved oxygen:
- 5.6-11.0 mg O2/L
- Salinity:
- Not stated
- Nominal and measured concentrations:
- Following a range-finding tests, a 'limit test' was conducted at a concentration of 100% v/v saturated solution.
- Details on test conditions:
- TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): covered to reduce evaporation
- Material, size, headspace, fill volume: 20 litre glass vessels
- Aeration: none
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): Not applicable
- Biomass loading rate: 1.08g bodyweight/litre
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated laboratory tap water
- Total organic carbon: 4.53 mg C/L
- Alkalinity: 130 mg/l as CaCO3
- Conductivity: 459 µS/cm
OTHER TEST CONDITIONS
- Photoperiod: 16 hours light/8 hours dark
- Light intensity: not stated - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 other: % v/v
- Nominal / measured:
- nominal
- Conc. based on:
- dissolved
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- > 100 other: % v/v
- Nominal / measured:
- nominal
- Conc. based on:
- dissolved
- Basis for effect:
- mortality (fish)
- Details on results:
- The results of the definitive test showed the highest test concentration resulting in 0% mortality to be greater than or equal to 100% v/v saturated solution, the lowest test concentration resulting in 100% mortality to be greater than 100% v/v saturated solution and the No Observed Effect Concentration (NOEC) to be 100% v/v saturated solution. The No Observed Effect Concentration is based upon zero mortalities and the absence of any sub-lethal effects of exposure at this concentration.
- Results with reference substance (positive control):
- Not applicable
- Reported statistics and error estimates:
- Estimated LC50 value is based upon inspection of the mortality data.
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Table 1. Cummulative mortality data in the range-finding test.
Nominal Concentration (% v/v saturated solution) Cumulative mortality (initial population =3) 3 hours 6 hours 24 hours 48 hours 72 hours 96 hours Control 0 0 0 0 0 0 100 0 0 0 0 0 0 Table 2. Cumulative mortality data in the definitive test.
Nominal Concentration (% v/v saturated solution) Cumulative mortality (initial population =3) % Mortality 3 hours 6 hours 24 hours 48 hours 72 hours 96 hours 96 hours Control R1 0 0 0 0 0 0 0 Control R2 0 0 0 0 0 0 0 100 R1 0 0 0 0 0 0 0 100 R2 0 0 0 0 0 0 0 100 R3 0 0 0 0 0 0 0
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- Validation criteria (as above) were fullfilled.
- Conclusions:
- The acute toxicity of the test material to freshwater rainbow trout has been investigated and gave a 96-hour LC50 of >100% v/v saturated solution. The corresponding NOEC was 100% v/v saturated solution.
- Executive summary:
Introduction
A study was performed to assess the acute toxicity of the test material to rainbow trout (Oncorhynchus mykiss).The method followed that described in the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC), US CFR Title 40 Part 797 Section 1400: US EPA Pesticide Assessment Guideline, Sub-Division E Section 72-1 and US EPA Draft Ecological Effects Test Guideline OPPTS 850.1075.
Methods.
Following a preliminary range-finding test, fish were exposed, in three groups of ten, to a saturated solution of the test material for a period of 96 hours at a temperature of 14°C to 16°C under semi-static test conditions. The test material solution was prepared by stirring an excess (100 mg/L) of test material via propeller stirrer in dechlorinated tap water at approximately 1500 rpm at a temperature of approximately 14°C for 24 hours prior to removing any undissolved test material by filtration (0.2µm Sartopore filter, first approximate 1 litre discarded in order to pre-condition the filter) to produce a saturated solution. The number of mortalities and any sublethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.
Results.
The 96-Hour LC50 based on nominal test concentrations was greater than 100% v/v saturated solution and correspondingly the No Observed Effect Concentration was 100% v/v saturated solution.
The chromatograms for the saturated solutions of the test material showed two sets of peaks, one set at approximately 4 to 6 minutes and one set at 8 to 12 minutes. The peaks at 8 to 12 minutes were consistent with the test material standard and were considered to be the test material AS305BD. It was considered, and agreed with the Sponsor, that the peaks at 4 to 6 minutes were consistent with those of AL305B a starting component in the production of the test material AS305BD. The test preparations were therefore analysed for both the notifiable material AS305BD and unreacted AL305B present.
Analysis of the test preparations at 0 (fresh media), 24 (old media), 72 (fresh media) and 96 hours (old media) showed the measured concentrations for AS305BD to be less than the limit of quantitation of the analytical method with the exception of a single measured concentration of 0.0623 mg/L at 100% v/v saturated solution replicate R2 at 96 hours. This does not infer that no test material was in solution but that the dissolved concentration (i.e. bioavailable to the test organisms) was below the limit of quantitation which was assessed down to 0.019 mg/L. The measured concentration of AS305BD observed in 100% v/v saturated solution replicate R2 at 96 hours was considered to be possibly due to post-sampling contamination given that no test material was quantified in the corresponding freshly prepared test sample at 72 hours. This was considered to have no effect on the overall results as no mortalities or sub-lethal effects of exposure were observed in this test replicate.
Analysis of the test preparations at 0 (fresh media), 24 (old media), 72 (fresh media) and 96 hours (old media) showed the measured concentrations for AL305B to be less than the limit of quantitation of the analytical method. This does not infer that no test material was in solution but that the dissolved concentration (i.e. bioavailable to the test organisms) was below the limit of quantitation which was assessed down to 0.0045 mg/L.
This study showed that there were no toxic effects at saturation.
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.