Registration Dossier
Registration Dossier
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.
A mixture of: pentasodium 7-amino-3-[[4-[[4-[[4-[[4-[(6-amino-1-hydroxy-3-sulfonato-2-naphthyl)azo]7-sulfonato-1-naphthyl]azo]phenyl]amino]-3-sulfonatophenyl]azo]6-sulfonato-1-naphthyl]azo]-4-hydroxynaphthalen-2-sulfonate; a mixture of: pentasodium 7-amino-8-[4-[4-[4-[4-(2-amino-5-hydroxy-7-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate and pentasodium 7-amino-8-[4-[4-[4-[4-(6-amino-1-hydroxy-3-sulfonato-naphthalen-1-ylazo)-7-sulfonatonaphthalen-1-ylazo]-phenylamino]-3-sulfonato-phenylazo]-6-sulfonato-naphthalen-1-ylazo]-4-hydroxy-naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-hydroxy-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate; tetrasodium 7-amino-4-hydroxy-3-[4-[4-[4-(4-amino-7-sulfonato-naphthalen-1-ylazo)-2-sulfonato-phenylamino]phenylazo]-6-sulfonato-naphthalen-1-ylazo]naphthalene-2-sulfonate
EC number: 415-350-3 | CAS number: - COLUMBIADUNKELBLAU R
- 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

Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- migrated information
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- A test was performed on analogue substance following OECD 202. The results show that the tested item is not toxic to Aquatic algae, ErC50 > 100 mg/L.
Based on the read across consideration the same results apply to Direct Blue 299. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 2011
- Principles of method if other than guideline:
- The 72 h algal growth inhibition test with Raphidocelis subcapitata
was done according to OECD 201 (2011) and ISO 8692 (2012) guidelines
with slight modifications. Algae were routinely cultured at
25±1 °C with light in Cyanobacteria BG-11 Freshwater Solution. The
culture was split twice a week, adding fresh medium. Algae were exposed
to the treatment in sterile 24-well plates with 2 mL of each
treatment solution to the respective microplate well, for three days.
Untreated ISO formulation freshwater and potassium dichromate (0.10
– 1.8 mg/L) were used as negative and positive controls respectively.
Each treatment was replicated three times and randomized within the
plate. Algal stock solution containing 1.01E6 cells/mL was added
(20 μL) to each well to obtain a starting algal density of 1E4 cells/mL.
Plates were incubated for 72 h at 25±1 °C on an orbital shaker
(90 rpm) in a thermostatic chamber. Light was provided by a 2 W LED
Unit for each plate. Algal density at the beginning and end of treatment
was measured with a TC20™ Automated Cell Counter (Bio-Rad Laboratories,
Inc), selecting a gate of 4–14 μm or by visual scoring with a
Burker's chamber. Results were expressed as effect on biomass (EbC50)
and on growth rate (ErC50).
The procedure was used for both limit tests and concentration-response
studies. For the limit tests, algae were exposed to each dyes at
100 mg/L. Dyes with 72 h NOEbC higher than 100 mg/L were considered
“non-toxic” while dyes with 72 h NOEbC lower than 100 mg/L
were considered “potentially toxic” and further investigated with a full
dose-response curve. Finally, only dyes with 72 ErC50 lower than
100 mg/L were classified as “toxic” according to the OECD guideline. - GLP compliance:
- no
- Specific details on test material used for the study:
- Potassium dichromate and BG-11 medium were purchased from
Sigma (St. Louis, MO, USA). Daphtoxkit F™ magna and ISO algal
medium were purchased from the national distributor of MicroBioTests
Inc. (Belgium). Raphidocelis subcapitata was routinely maintained from
a frozen aliquot generated by algae purchased from the national distributor
of MicroBioTests Inc. - Analytical monitoring:
- yes
- Vehicle:
- yes
- Details on test solutions:
- BG-11 medium were purchased from Sigma (St. Louis, MO, USA).
- Test organisms (species):
- other: Raphidocelis subcapitata
- Details on test organisms:
- Raphidocelis subcapitata was routinely maintained from
a frozen aliquot generated by algae purchased from the national distributor
of MicroBioTests Inc. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 72 h
- Test temperature:
- 25±1 °C
- Nominal and measured concentrations:
- Algal stock solution containing 1.01E6 cells/mL was added
(20 μL) to each well to obtain a starting algal density of 1E4 cells/mL. - Details on test conditions:
- Plates were incubated for 72 h at 25±1 °C on an orbital shaker
(90 rpm) in a thermostatic chamber. Light was provided by a 2 W LED
Unit for each plate. Algal density at the beginning and end of treatment
was measured with a TC20™ Automated Cell Counter (Bio-Rad Laboratories,
Inc), selecting a gate of 4–14 μm or by visual scoring with a
Burker's chamber. Results were expressed as effect on biomass (EbC50)
and on growth rate (ErC50). - Reference substance (positive control):
- not specified
- Duration:
- 72 h
- Dose descriptor:
- other: ErC50, Effect on growth rate
- Effect conc.:
- < 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- cell number
- Results with reference substance (positive control):
- Untreated ISO formulation freshwater and potassium dichromate (0.10 – 1.8 mg/L) were used as negative and positive controls respectively.
- Validity criteria fulfilled:
- not specified
- Conclusions:
- non toxic
- Executive summary:
Direct Blue 293
Limit Test (NOEbC>100)
72 h EC50 with P. subcapitata (mg/L)
ErC50 test 1
146.770
test 2
137.975
test 3
157.013
Reference
Description of key information
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 137.975 mg/L
Additional information
A test was performed on analogue substance following OECD 202. The results show that the tested item is not toxic.
Based on the read across consideration the same results apply to Direct Blue 299.
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.
