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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 413-550-5 | CAS number: 142068-96-0 H112339
- 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
Long-term toxicity to fish
Administrative data
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- July 9 2002 - August 10 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted to current recognised methodology
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- Deviations:
- yes
- Principles of method if other than guideline:
- The temperature fluctuation in the course of the study exceeded 1.5°C and did not remain in the temperature range from 23-27°C. The results obtained for the control (hatching success 88.3%; post hatch success 88.7%) demonstrate that this slight deviation from the demands of the guideline does not affect the validity of the study.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Octasodium 2-(8-(4-chloro-6-(3-((4-chloro-6-(3,6-disulfonato-2-(1,5-disulfonatonaphthalen-2-ylazo)-1-hydroxynaphthalen-8-ylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,6-disulfonato-1-hydroxynaphthalen-2-ylazo)naphthalene-1,5-disulfonate
- EC Number:
- 413-550-5
- EC Name:
- Octasodium 2-(8-(4-chloro-6-(3-((4-chloro-6-(3,6-disulfonato-2-(1,5-disulfonatonaphthalen-2-ylazo)-1-hydroxynaphthalen-8-ylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,6-disulfonato-1-hydroxynaphthalen-2-ylazo)naphthalene-1,5-disulfonate
- Cas Number:
- 142068-96-0
- Molecular formula:
- Hill formula: C53H28Cl2N14Na8O26S8
- IUPAC Name:
- octasodium 5-[(4-chloro-6-{[4-({[4-chloro-6-({7-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-8-hydroxy-3,6-disulfonatonaphthalen-1-yl}amino)-1,3,5-triazin-2-yl]amino}methyl)phenyl]amino}-1,3,5-triazin-2-yl)amino]-3-[2-(1,5-disulfonatonaphthalen-2-yl)diazen-1-yl]-4-hydroxynaphthalene-2,7-disulfonate
- Details on test material:
- - Name of test material (as cited in study report): Procion Karminrot H112239
- Molecular formula (if other than submission substance): C53 H28 Cl2 N14 O26 S8 Na8
- Molecular weight (if other than submission substance): 1785.0 g/mol (according to data of the sponsor)
- Substance type: Organic
- Physical state: Solid
- Analytical purity: 63.8 % (according to data of the sponsor)
- Impurities (identity and concentrations): None identified
- Lot/batch No.: 5K/Brunsbuttel
- Stability under test conditions: Verified by chemical analysis (HPLC) during the study.
Constituent 1
- 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:
- - Concentrations: 1.0, 3.16 and 10 mg/l
- Sampling method: Direct sampling
- Sample storage conditions before analysis: None; analysis conducted post sampling.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Identity and concentration of auxiliary solvent for dispersal: None; a stock solution was prepared for the required concentrations.
Test organisms
- Test organisms (species):
- Pimephales promelas
- Details on test organisms:
- Type: Fathead minnow (Pimephales promelas RAFINESQUE)
Source: laboratory brood (strain: Bio International, Netherlands)
Date of Birth: March 9,2001
Acclimatisation: Stock acclimatised since January 31, 2002 to the test conditions.
Temperature: 23 - 27 °C
Dissolved Oxygen: >5mg/l
Feeding: Tetramin fish food, ground, 2 % of body weight per day, applicated in 3 portions daily (10.00 a.m., 13.00 a.m., 4.00 p.m.) Artemia salrna, Daphnids or Lavae of Chironomus. ripariits (frozen) ad libitum, daily. On weekends feeding only with Tetra Min fish food.
Mortalities during acclimatisation period: < 5 %
Medication: none
Holding and dilution water: Reconstituted water prepared according to the recommendations of ISO 7346. This freshly prepared standard dilution water is used for both, the maintenance of the test animals under flow-through conditions and the preparation of stock and test solutions of the test substance.
Study design
- Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 32 d
- Post exposure observation period:
- None
Test conditions
- Hardness:
- The total hardness of the dilution water, measured 5 times during the test, ranged from 9.8°dH- 125°dH(= 174.9 mg/l CaCO3-223.1 mg/l CaCO3).
- Test temperature:
- 23 - 27°C
- pH:
- 7.5-7.9
- Dissolved oxygen:
- 7.3 - 8.4 mg/l
- Salinity:
- Not applicable
- Nominal and measured concentrations:
- 1.0, 3.16 and 10 mg/l (nominal)
- Details on test conditions:
- Pretreatment of the test substance: A stock solution was prepared to give the desired series of test concentrations.
Exposure conditions:
Test Vessels: glass vessels, diameter 14 cm, height 7.5 cm glass aquaria holding 51 of test media
Experimental design:
3 test concentrations plus control
60 fertilised eggs per test concentration and control evenly distributed into two replicates
flow-through system
Method of initiation: fertilised eggs (16 - 256 cell stage) were placed hi prepared media
Photoperiod: 16h light:8h dark
Temperature: mean +/-1.5 °C (in the temperature range 23 - 27 °C)
Aeration: gentle aeration via narrow glass tubes after hatching of larvae (start of aeration: July 15,2002)
Test concentration/s (nominal): 1.0, 3.16 and 10 mg/l
Method of administration: stock solution
Medium renewal: continuously
Duration of exposure: 32 days
Criteria of effects:
- Hatching success;
- Mortality,
- Body abnormalities;
- Type and incidence of behavioural abnormalities;
- Length of juvenile fish at the end of the test period;
- Fresh-weight of juvenile fish at the end of the test period - Reference substance (positive control):
- no
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 32 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 3.61 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Total Survival
- Duration:
- 32 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 10.43 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Total survival
- Duration:
- 32 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 10.34 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Hatching success, post hatch survival, length
- Duration:
- 32 d
- Dose descriptor:
- LOEC
- Effect conc.:
- > 10.34 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Hatching success, post hatch survival, length
- Details on results:
- Signs of toxicity: None visible
- Results with reference substance (positive control):
- Not applicable.
- Reported statistics and error estimates:
- The statistical analysis of the results was performed using the software „Toxrat (ToxRat Solutions GmbH, Alsdorf, Germany). The following parameters were statistically evaluated: post hatch survival (larval survival) after 32 d, total survival after 32d, weight of fish after 32d, length of fish after 32d.
As no dose response relationship is obvious for the parameter ..hatching success", and additionally the mean hatching success of the highest test substance concentration was only 5% below the observed value of the control, no statistical determination of the NOEC/LOEC'has been performed. As all hatching rates observed exceeded the demands of the OECD Guideline 210 the highest test substance concentration of nominally 10.0 mg/l was considered to be the No Observed Effect Concentration (NOEC)
Any other information on results incl. tables
The temperature fluctuation in the course of the study exceeded 1.5°C and did not remain in the temperature range from 23-27°C. The results obtained for the control (hatching success 88.3%; post hatch success 88.7%) demonstrate that this slight deviation from the demands of the guideline does not affect the validity of the study,
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The recognised NOEC is 3.61 mg/l after 32 days based on survival & weight of juveniles
- Executive summary:
Based on different biological effects observed and endpoints assessed, the following results were obtained at the end of the 32 day exposure period of the Fish. Early-life Stage Toxicity Test:
Results [mg/l]:
NOEC(Total survival) 3.61 mg/l.
LOEC (Total survival) 10.43 mg/l
NOEC(Hatching success, post hatch survival, length) ≥ 10.43 mg/l.
LOEC(Hatching success, post hatch survival, length) > 10.43 mg/l
All results are expressed in terms of mean measured concentrations during exposure period. Measured concentrations ranged from 69.0% -101% of nominal values of Procion Karminrot H-EXL - H112339 during acclimatisation phase and from 90.7% -152.8% of nominal values of Procion Karminrot H-BXL-H 112339 during exposure period.
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.