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EC number: 288-897-7 | CAS number: 85940-09-6
- 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:
- 02 March-13 June, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 17 July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Version / remarks:
- 30 March 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Date of production: May 22, 2015
Expiry date: May 22, 2020 - Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: For determination of the test item concentration, samples were taken from the treatment group and the control at the start and at the end of the renewal period.
- Vehicle:
- yes
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: As the test item is poorly soluble in deionized water as well in the test medium, preparation of test solution was performed using the WAF method (according to OECD Series on Testing and Assessment No. 23). Appropriate amount of test item was suspended in the dilution water (ISO Medium; see 4.4) in order to give the loading rate of 100 mg test item/L. The solution was handled by ultrasonic bath for 10 minutes thereafter stirred for a period of approximately 24 hours to achieve equilibrated concentration. The solution was then filtrated through a membrane filter (0.45 µm) to separate the possible non-dissolved test material. Untreated control group (ISO Medium without test item) was included in the test. As the test item was not stable for the duration of 96 hours in ISO Medium, a semi-static test was performed with a renewal on day 2.
- Controls: Negative control (dilution water only) - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: Zebrafish
- Source: Akvárium Magazin Kft. (Pasaréti Gyula), 1222 Budapest, Dévény u. 36., Hungary
- Number of animals: 10 animals at each group (no replicates were used)
- Age and size of animals: Juveniles; size within a range of 2.0 ± 1 cm. The loading of the test aquaria did not exceed 1.0 g/L.
- Sex: Both female and male (not separated).
ACCLIMATION
- Acclimation period: Fish were held for at least 12 days before test initiation
- Acclimation conditions: Same as test
- Type and amount of food during acclimation: During holding, fish were fed with appropriate, commercial diet.
- Feeding frequency during acclimation: At least three times per week until 24 hours before the test started.
- Health during acclimation: Apparently healthy animals were used in the test.
FEEDING DURING TEST : No - Test type:
- semi-static
- Water media type:
- other: reconstituted water (ISO medium, prepared according to Annex 2 of the OECD guideline 203)
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Remarks on exposure duration:
- Fish were exposed to aqueous test media containing the test item for 96 hours in a semi-static test (renewal on day 2). Ten fish were exposed to the test concentration and ten fish were included as control (no replicates were used).
- Post exposure observation period:
- Fish were observed at approximately 4, 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality. Measurements of pH, dissolved oxygen and temperature were carried out daily.
- Hardness:
- The measured hardness of the ISO Medium used in the study was 242.08 mg/L (as CaCO3).
- Test temperature:
- The measured temperatures were within a range of 21.6 - 22.5°C in the test aquariums (the maximum deviation did not exceed ± 1°C).
- pH:
- The test was carried out without adjustment of pH. The measured pH values were in the range of 7.18 - 7.80 during the test.
- Dissolved oxygen:
- The dissolved oxygen concentration was in the range of 78.0 - 97.2 % of the air saturation value at the temperature used.
- Salinity:
- Not applicable
- Conductivity:
- Not specified
- Nominal and measured concentrations:
- Limit test; using a single nominal concentration of 100 mg/L and a concurrent control.
The measured concentrations deviated more than 20 % from the nominal concentration at the start and at the end of the renewal periods, therefore the geometric mean of the measured concentration was calculated to determine exposure concentration. The corresponding calculated concentration was 0.040 mg/L (based on total product). - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass aquaria
- Aeration: Yes
- Renewal rate of test solution: Renewal on day 2
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per negative control: 1
- Biomass loading rate: < 1.0 g fish / L test solution
TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: ISO Medium according to guideline
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 h light: 8 h dark
EFFECT PARAMETERS MEASURED: The fish were observed at 24, 48, 72 and 96 hours after start of the test for signs of intoxication and mortality. Fish were considered dead if there was no visible movement (e.g. gill movements) and if touching of the caudal peduncle produces no reaction. Dead fish were removed when observed and mortalities were recorded. All sub-lethal effects were recorded.
NON-GLP RANGE FINDING STUDY
In order to select appropriate test concentrations for use in the definitive test, non-GLP preliminary tests were performed at the nominal concentration of 100 mg/L. The first pre-test was a static test while in the second pre-test the test solutions were renewed daily. In both preliminary range-finding tests the test solution was prepared by dissolving an amount of 0.1 g test item in 1000 mL ISO Medium to obtain the 100 mg/L nominal test concentration. This solution was stirred rigorously for about 18 hours, thereafter filtrated through a membrane filter (0.45 µm) to separate the possible non-dissolved test material. Three fish were exposed for 96 hours in the test item treated and control group. No replicates were included in the pre-tests. No mortality or any sub-lethal effects were detected in the treatment group or in the control group during the 96-h exposure period in both preliminary range finding tests.
The preliminary range-finding tests were not performed in compliance with the GLP-Regulations and are excluded from the Statement of Compliance.
- Results used to determine the conditions for the definitive study: Yes - Reference substance (positive control):
- not required
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: corresponding to > 0.04 mg/L mean measured
- Key result
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.04 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mortality (fish)
- Remarks:
- or sublethal effect
- Remarks on result:
- other: the test item Yellow 22 had no toxic effect on fish at aquatic saturation (i.e. limit test concentration)
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 0.04 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- mortality (fish)
- Remarks:
- or sublethal effect
- Remarks on result:
- other: the test item Yellow 22 had no toxic effect on fish at aquatic saturation (i.e. limit test concentration)
- Details on results:
- - Behavioural abnormalities:
- Observations on body length and weight: No sub-lethal effects
- Other biological observations: No
- Mortality of control: No
- Other adverse effects control: No
- Abnormal responses: No
- Any observations that might cause a difference between measured and nominal values: No (WAF)
- Effect concentrations exceeding solubility of substance in test medium: Nominal loading rate of 100 mg/L exceeded the water solubility - Results with reference substance (positive control):
- Not performed.
- Reported statistics and error estimates:
- Since a limit test was performed (and mortality is not expected), no statistical analysis is necessary. The endpoints will be determined directly from the raw data.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In this 96-hour acute toxicity test on Zebrafish (Danio rerio) the test item Yellow 22 had no toxic effect on fish at aquatic saturation (i.e. limit test concentration). Accordingly, the 96-h NOEC was determined to be 0.040 mg/L and the LOEC > 0.040 mg/L (based on total product), equivalent to 100 mg/L and > 100 mg/L nominal loading rate respectively.
- Executive summary:
The acute toxicity of the test item to Danio rerio was determined in a 96-hour semi-static test according to the Commission Regulation (EC) No 440/2008, Annex Part C, C.1 and OECD Guideline for Testing of Chemicals, Section 2, No. 203. The 96 -h NOEC was determined to be 0.040 mg/L (equivalent to 100 mg/L nominal loading rate) and the LOEC > 0.040 mg/L (equivalent to > 100 mg/L nominal loading rate).
Reference
Description of key information
In the 96-hour test according to OECD Guideline 203 on Danio rerio the read across substance Yellow 22 (CAS 90268 -98 -7) had no toxic effect on fish at aquatic saturation (i.e. limit test concentration). Accordingly, the 96 -h NOEC was determined to be 0.040 mg/L and the LOEC > 0.040 mg/L (based on total product), equivalent to 100 mg/L and > 100 mg/L nominal loading rate, respectively.
Key value for chemical safety assessment
Additional information
The acute toxicity of the read across substance Yellow 22 (CAS 90268 -98 -7) to Danio rerio was determined in a 96 -hour semi-static test according to the Commission Regulation (EC) No 440/2008, Annex Part C, C.1 and OECD Guideline for Testing of Chemicals, Section 2, No. 203. The 96-h NOEC was determined to be 0.040 mg/L (equivalent to 100 mg/L nominal loading rate) and the LOEC > 0.040 mg/L (equivalent to > 100 mg/L nominal loading rate).
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