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EC number: 700-493-9 | CAS number: 1228180-58-2
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29-Nov-2010 to 21-Dec-2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- 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. Conclusive valid guideline study under GLP conditions.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.1 (Acute Toxicity for Fish)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), C.
- Deviations:
- no
- Principles of method if other than guideline:
- A limit test was performed to demonstrate that the test item has no toxic effect on the test fish up to loading rate of 100 mg/L.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- swissmedic: Date of inspection: 05 to 09-Nov-2007 and 26 to 30-Nov-2007; Date of decision: 2008-04-30, Date of signature: 12-Nov-2008
Test material
- Reference substance name:
- Acid Yellow RN 2903
- IUPAC Name:
- Acid Yellow RN 2903
- Reference substance name:
- Vers. Kilo 6, 26.05.2009
- IUPAC Name:
- Vers. Kilo 6, 26.05.2009
- Details on test material:
- The test item and the following information concerning the test item were provided by the Sponsor:
Identity: Acid Yellow RN 2903
Batch No.: Vers. Kilo 6, 26.05.2009
Purity: Approx. 65%
Expiration Date: 01-Aug-2015
Storage Conditions: At room temperature at about 20 °C, in the dark
Constituent 1
Constituent 2
- 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:
- For the determination of the actual test item concentrations, duplicate samples were taken from each treatment just before test start (Day 0) and on the last day of preparation (Day 3), and at the end of the first and last renewal period (Day 1 and Day 4, respectively).
All samples were taken from the approximate center of each aquarium without mixing the test medium, and were stored deep-frozen (at about -20 °C) immediately after sampling. The concentration of the test item Acid Yellow RN 2903 was determined in all test medium samples.
From the control samples, only one of the duplicate samples was analyzed per sampling time. The analytical procedure and results are described in the attached Appendix I - Analytical Investigations.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- At the start of the test and before each test medium renewal, the test medium with the loading rate of 100 mg/L was freshly prepared by completely dissolving 500 mg of the test item in five liter of test water using ultrasonic treatment for 5 minutes and stirring for 15 minutes at room temperature. Then, the dispersion was left undisturbed for 24 hours in the dark to allow precipitation of the test item. After the 24 h resting period, the dispersion was filtered through a membrane filter (Schleicher & Schuell, Type NC45, pore size 0.45 µm) just before introduction of the fish (= start of the exposure and prior to each test medium renewal). The undiluted filtrate containing the maximum concentration of dissolved test item was used as the test medium.
The preparation of the test medium was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000.
Test organisms
- Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- The study was performed with zebra fish (Brachydanio rerio). The fish were obtained from a breeding culture at Harlan Laboratories. No medication was applied during holding and acclimatization. Prior to test start, the test fish were acclimated for one week to the test water and temperature. During holding and acclimatization until one day before the start of the test, the fish were fed with a commercial fish diet (Tetra Min® Hauptfutter, supplied by TETRA-Werke, 49304 Melle / Germany). During holding and acclimatization, no fish died in the test fish batch and all fish were healthy.
From the acclimated test fish batch, 10 fish were measured at the start of the test. The mean body length of the fish was 2.97± 0.14 cm (Mean ± SD), the mean body wet weight was 0.17 ± 0.03 g (Mean ± SD).
The test method and test species are recommended by the international test guidelines.
Study design
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Post exposure observation period:
- not applicable
Test conditions
- Hardness:
- 1.25 mmol/L
- Test temperature:
- The water temperature was 21 °C during the test (see attached Table 4).
- pH:
- The pH values in all treatments ranged from 7.4 to 7.5 (see attached Table 2).
- Dissolved oxygen:
- The oxygen concentration was always 8.1 mg/L or higher (see attached Table 3), and thus higher than 60% oxygen saturation.
- Salinity:
- according to OECD guideline
- Nominal and measured concentrations:
- An undiluted filtrate with the mean measured concentration of 12 mg/L was tested as a single concentration of the test item. In the analyzed test medium samples from the start and end of the first and last test medium renewal periods the measured test item concentrations were 13/15 and 9.4/9.3 mg/L, respectively (see attached Appendix I - Analytical Investigations). The reported biological results were related to the mean measured test item concentration of 12 mg/L.
- Details on test conditions:
- One glass test vessel with four liters of test medium was used for each treatment. The test vessels were labeled with the study number and all necessary additional information to ensure unique identification.
The water temperature in the test vessels was maintained at 21 °C (see attached Table 4). The test vessels were slightly aerated during the test period. A 16 hour light to 8-hour dark photoperiod, with a 30-minute transition period was used light intensity during the light period was approximately within the range of 140 to 480 Lux. The test duration was 96 hours and the fish were not fed during the test.
A limit test was performed in accordance with the test guidelines to demonstrate that the test item has no toxic effect on the test fish up to the highest concentration which could be dissolved in the test water. Thus, an undiluted filtrate with the mean measured concentration of 12 mg/L was tested as a single concentration of the test item. Additionally, a control was tested in parallel. - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 96 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 12 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC0
- Effect conc.:
- >= 12 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 12 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 12 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LC100
- Effect conc.:
- > 12 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- In the analyzed test medium samples from the start and end of the first and last test medium renewal periods the measured test item concentrations were 13/15 and 9.4/9.3 mg/L, respectively. The reported biological results were related to the mean measured test item concentration of 12 mg/L.
The biological results are listed in the attached Table 1. In the control and test medium with the mean measured concentration of 12 mg/L all fish survived until the end of the test and no visible abnormalities were observed at the test fish. Therefore, the 96 hour NOEC and LC0 of Acid Yellow RN 2903 to zebra fish were both determined to be at least 12 mg/L. The 96 hour LOEC, LC50 and LC100 were clearly higher than 12 mg/L.
In conclusion, the test item Acid Yellow RN 2903 had no acute toxic effects on zebra fish up to solubility limit of the test item in the test water.
No remarkable observations were made concerning the appearance of the test medium. It was colored by the test item throughout the entire test duration.
The pH values in all treatments ranged from 7.4 to 7.5 (see attached Table 2). The oxygen concentration was always 8.1 mg/L or higher (see attached Table 3), and thus higher than 60% oxygen saturation. The water temperature was 21 °C during the test (see attached Table 4). - Results with reference substance (positive control):
- not applicable
- Reported statistics and error estimates:
- The NOEC and LC0 were determined directly from the raw data. The LOEC, LC100 and LC50 at the observation times could not be quantified due to the absence of a toxic effect of the test item at the tested concentration.
Any other information on results incl. tables
- Sublethal observations / clinical signs:
Attachments:
Appendix I - Analytical Investigations
Appendix II - Tables 1 to 4:
Table 1: Mortality and Visible Abnormalities Observed in the Test Fish
Table 2: pH in the Freshly Prepared and Old Treatment Media
Table 3: Oxygen Concentrations (mg/L) in the Freshly Prepared and Old Treatment Media
Table 4: Temperatures (°C) in the Freshly Prepared and Old Treatment Media
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In conclusion, the test item Acid Yellow RN 2903 had no acute toxic effects on zebra fish up to solubility limit of the test item in the test water.
- Executive summary:
The acute toxicity of the test item Acid Yellow RN 2903 to zebra fish (Brachydanio rerio) was determined in a 96‑hour semi-static test with daily test medium renewal according to the EU Commission Directive 92/69/EEC, Part C.1, the Commission Regulation (EC) No 440/2008, Part C.1 and the OECD Guideline for Testing of Chemicals No. 203 (1992).
A limit test was performed in accordance with the test guidelines to demonstrate that the test item has no toxic effect on the test fish up to loading rate of 100 mg/L.
Due to the low water solubility of the test item, a dispersion of the test item with the loading rate of 100 mg/L was prepared using ultrasonic treatment for 5 min and intense stirring at room temperature for 15 min. The so prepared dispersion was left undisturbed over 24 hours in the dark.Then, the dispersion was filtered.The undiluted filtrate with the maximum concentration of dissolved test item was used as the test medium. Additionally, a control was tested in parallel.
The preparation of the test medium was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000.
In the analyzed test medium samples from the start and end of the first and last test medium renewal periods the measured test item concentrations were 13/15 and 9.4/9.3 mg/L, respectively. The reported biological results were related to the mean measured test item concentration of 12 mg/L.
In the control and at the mean measured concentration of 12 mg/L, no mortality or other visible abnormalities were determined during the test period of 96 hours.
The biological test results (based on mean measured concentration of the test item) were as follows:
Mean measured concentration
(mg/L)– 96-hour LC50:
>12
– 96-hour LC0:
>=12
– 96-hour LC100:
>12
– 96-hour NOEC:
>=12
– 96-hour LOEC:
>12
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