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Diss Factsheets
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EC number: 207-586-9 | CAS number: 482-89-3
- 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
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Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
Description of key information
No adverse effects were observed at the limit of solubility
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.35 mg/L
Additional information
A daphnia reproduction study with indigo is reported in the OECD SID document for Indigo Blue. The OECD guideline followed for this study was reported to be OECD test guideline 202 dated 1984, which is the test guideline for acute daphnia studies. No details on study conduct of test substance are available. Almost all concentrations tested (0.78 to 78 mg/L) were above the value for water solubility of 0.99 mg/L as stated in the OECD SIDS document. The test substance concentrations were tested in an extremely high concentration of the co-solvent DMSO:HCO-40 = 9:1 (1000 mg/L) without giving any information on solubility of Indigo in this solvent or effects seen in the vehicle control group. No analytical monitoring took place during the study. As DMSO has surface active properties, the use of high concentrations in the daphnia tests could effect the mobility and mortality of the daphnids, as surface active substances prevent the daphnids from diving and thus lead to the death of the daphnia. No information on effects of mobility of the daphnids were given in the OECD SIDS document. Hence, it is unknown whether the effects seen are due to the vehicle used or not, especially as they lie above the limit of water solubility for Indigo.
As a consequence, this study is deemed not reliable and cannot be used for assessment of the registered substance.
A second study (Bruns E, 2005) is available on reproductive effects on Daphnia magna conducted according to OECD test guideline 211 (Daphnia magna ( Reproduction Test; adopted: Sept. 21, 1998). This test was performed with a well-defined Indigo batch, which is in representative for the registered substance.
The dose levels used in this semi-static study were 0.0035 to 0.35 mg/L, which is lower than the water solubility of Indigo of 0.99 mg/L as reported in the OECD SIDS document (without providing the test method used). The Lead Registrant's own report for water solubility, conducted by BASF using a spectrophotometric test method, reports the water solubility of Indigo to be below the limit for quantification of 0.05 mg/L. Analytical monitoring (HPLC) took place throughout the study in the stock solution as well as the test vessels of the highest test concentration. Analytical monitoring of all other concentrations tested was not possible, as these concentrations were below the lower limit of quantification of the analytical test method used. No test substance-related effects were noted on mortality or reproduction rate at any concentration tested. The reproductive output of the Daphnia exposed to the test item was compared to that of the control in order to determine the Lowest Observed Effect Concentration (LOEC) and the No Observed Effect Concentration (NOEC) according to DUNNETT (1955, 1964). Additionally, the survival of the parent daphnia and the time to production of first brood was determined. 21 d NOEC (reproduction): >= 0.35 mg/L21 d LOEC (reproduction): > 0.35 mg/L
21 d NOEC (mortality): >= 0.35 mg/L
21 d LOEC (mortality): > 0.35 mg/L
1st brood on day: 5
The results are expressed in terms of nominal concentrations. Recovery rates ranged from 51.0 - 98.4% of the nominal values in the freshly prepared media and from 41.7 - 80.1% of nominal values in the media after 48 hours or 72 hours of exposure. It is hence concluded that Indigo has no effect on daphnia reproduction or survival after 21 days of exposure at the limit of water solubility.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.
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