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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 236-164-7 | CAS number: 13197-76-7
- 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
- Study period:
- June to August 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- One main deviation noted, no chemical analysis was performed. The report is brief and doesn’t include background details of culturing etc.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Deviations:
- yes
- Remarks:
- One main deviation noted, no chemical analysis was performed.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Betadet S-20
Batch number 2GR043.0001
The Certificate of Analysis (not included in the report) provides the following information:
Batch: 2GR043.0001 (19/10/1995)
Appearance: Liquid, transparent, slightly yellowish fluid
Dry matter: 45%
pH: 6.8
Colour: 36 APHA units
Sodium chloride: 7.1%
The principal constituent (included in the 45% 'dry matter') represented approximately 30% (w/w) of the tested batch. - Analytical monitoring:
- no
- Details on sampling:
- Not applicable
- Vehicle:
- no
- Details on test solutions:
- The test material was dissolved in water.
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- Fish were obtained from a commercial supplier: Meridiana Aquarium SA, Barcelona and were held in quarantine for 12 days prior to test initiation. The fish were fed daily, up to 24h before the start of the test.
Fish were held is glass aquaria with a capacity of 84 L, pH was in the range of 8.0 - 8.6 and temperature was maintained between 20 and 24°C.
Fish were 3.4 - 3.8 cm at the end of the preliminary study and 3.0 - 3.5 cm at the end of the definitive test. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Remarks on exposure duration:
- None
- Post exposure observation period:
- Not applicable
- Hardness:
- 195.8 - 231.4 mg/L as CaC03 during the definitive study
- Test temperature:
- 21.0 - 25.9°C
- pH:
- 8.15 - 8.46 during the definitive study
- Dissolved oxygen:
- Maintained between 65 and 90% of the Air Saturation Value
- Salinity:
- Not applicable (freshwater test)
- Conductivity:
- Not applicable
- Nominal and measured concentrations:
- Nominal exposure concentrations - 0 (control), 100, 141.4, 168.2, 200 and 400 mg/L.
- Details on test conditions:
- Test vessels used in the definitive test were glass aquaria containing 50 L of test medium.
20 fish were exposed in the control and 100, 168.2 and 200 mg/L treatments and 10 were exposed at the 141. and 400 mg/L treatments. - Reference substance (positive control):
- no
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 55.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- other: principal constituent
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: Calculated from reported endpoint as (184 x 0.3), based on 30% (w/w) principal constituent content of tested batch.
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 184 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: Endpoint determined by graphical interpolation from the mortality response curve.
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 168.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- < 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- behaviour
- Remarks on result:
- other: Symptoms included inactivity, sounding in the aquaria, cessation of swimming and rapid respiration.
- Details on results:
- The 96 h LC50 for Betadet S-20, based on nominal exposure concentrations was determined graphically to be 184 mg/L. This is equivalent to 55.2 mg principal constituent/L after correction for the 30% (w/w) p.c. content of the tested batch of Betadet S-20.
- Results with reference substance (positive control):
- Not applicable
- Reported statistics and error estimates:
- No statistical analyses were performed. The LC50 was determined graphically.
- Sublethal observations / clinical signs:
Mortality observations
Nominal concentration (mg/L)
No. of fish exposed
Cumulative mortality
% mortality at 96 hours
3 hours
24 hours
48 hours
72 hours
96 hours
Control
20
0
0
0
0
0
0
100
20
0
0
0
0
0
0
141.4
10
0
0
0
0
0
0
168.2
20
0
0
0
0
0
0
200
20
0
14
17
19
19
95
400
10
10
10
10
10
10
100
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 96 h LC50 for Betadet S-20, based on nominal exposure concentrations was determined graphically to be 184 mg/L. This is equivalent to 55.2 mg principal constituent/L after correction for the 30% (w/w) p.c. content of the tested batch of Betadet S-20.
- Executive summary:
The acute toxicity of Betadet S-20 to Zebra fish (Brachydanio rerio) was determined in a static study carried out according to OECD test guideline 201 (1992). Fish were exposed to nominal test concentrations of 0 (control), 100, 141.4, 168.2, 200 and 400 mg/L for 96 hours. No analytical verification was performed therefore the results of the study are based in the nominal exposure concentrations.
The 96 h LC50 for Betadet S-20 was determined graphically to be 184 mg/L with a corresponding NOEC of 168.2 mg/L, based on mortality. The LC50 and NOEC equate to 55.2 and 50.5 mg principal constituent/L, respectively, after correction for the p.c. content of the tested batch of Betadet S-20.
Reference
Description of key information
The 96 h LC50 for Danio rerio exposed to Betadet S-20 was determined to be 184 mg/L with a corresponding NOEC of 168.2 mg/L, based on mortality. The LC50 equates to 55.2 mg principal constituent/L after correction for the p.c. content of the tested batch of Betadet S-20.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 55.2 mg/L
Additional information
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.