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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 407-240-9 | CAS number: 159604-94-1 BLUE 10 25 964
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From December 18, 1990 to January 14, 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- May 12, 1981
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- (2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate
- EC Number:
- 407-240-9
- EC Name:
- (2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate
- Cas Number:
- 159604-94-1
- Molecular formula:
- C66H88Cu2N20O10S2.C3H5O3.C2H3O2
- IUPAC Name:
- 7,7'-bis[4-(3-diethylaminopropylamino)-6-(3-diethylammoniopropylamino)-1,3,5-triazin-2-ylamino]-{μ-4,4'-dihydroxy-1:2k2O4:O4'-3,3'-[3,3'-dihydroxy-1:2k2O3:O3'-biphenyl-bisazo-1:2(N3,N4-η:N3',N4'-η)]dinaphthalene-2-sulphonato(6-)}dicuprate(2-), mixed (1:1) acetic/lactic acid salts
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Wistar rat, outbred, SPF quality recognised by international guidelines as a recommended test system
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL Ltd., Basel Switzerland
- Age at study initiation: approximately 6 weeks
- Weight at study initiation: ca. 170 g
- Housing: animals were housed 5 to a cage (same sex) on stainless steel suspended cages with wire mesh floors
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days. Veterinary examinations was performed prior to commencement of treatment to ensure that the animals were in a good state of health.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Distilled water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Method: The test substance was weighted into a glass flask on an analytical balance and the vehicle (w/w) added.
Frequency of test substance formulation: Daily immediately prior to dosing
Homogeneity of test substance in vehicle: Test susbtance formulations were homogenised using an electric shaker and magnetic stirrer. Homogeneity during treatment was manteined using a magnetic stirrer. From chemical analysis the test substance appeared to be homogeneous in water at all concentrations used in this study.
Storage instructions for test substance formulation: At ambient temperature. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples of formulations prepared during week 1 were analysed to check the accuracy of preparation. Actual concentrations of preparations were in agreement with the treatment levels as per protocol.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Once daily, approximately the same time each day, 7 days per week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Slightly low body weight gain was noted among females receiving 1000 mg/kg/day over the 5 days of treatment. Based on these observations, a high treatment level of 1000 mg/kg/ day was selected for a study of 28 days duration.
- Rationale for animal assignment (if not random): computer-generated random algorithm according to body weight with all animals within ± 20% of the sex mean
- Fasting period before blood sampling for clinical biochemistry: the animals were fasted overnight before blood sampling, but water was provided.
- Dose range finding studies: A 5-day range finding study was performed (with 3 rats/sex/group at dose levels of 50, 200 and 1000 mg/kg/day) to provide a basis for selection of dose levels for a study of longer duration.
Slightly low body weight gain was noted among females receiving 1000 mg/kg/day over the 5 days of treatment.
No differences of biological significance were observed in clinical appearance, food consumption, macroscopic appearance or liver weights between the treated groups.
Based on these observations, a high treatment level of 1000 mg/kg/ day was selected for a study of 28 days duration.
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at least once daily
BODY WEIGHT: Yes
- Time schedule for examinations: weekly and on the day preceding termination, prior to overnight fasting.
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: before commencement of treatment and during the last week of treatment
- Dose groups that were examined: control, 50 mg/kg bw, 200 mg/kg bw and 1000 mg/kg bw
HAEMATOLOGY: Yes
- Time schedule for collection of blood: immediately prior to post mortem examination, between 8.00 and 10.00 a.m.
- Anaesthetic used for blood collection: Yes (ether)
- Animals fasted: Yes
- How many animals: all rats/sex/group
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: immediately prior to post mortem examination, between 8.00 and 10.00 a.m.
- Animals fasted: Yes
- How many animals: all rats/sex/group - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Slides of adrenals, heart, kidneys, liver, spleen and stomach, collected at termination from all animals of the control and high dose group as well as from all gross lesions of all animals were examined by a pathologist. - Statistics:
- The fol lowing statistical methods were used to analyse the body weight, organ weights and clinical laboratory data:
Univariate one-way analysis of variance was used to assess the significance of intergroup differences.
If the variables could be assumed to follow a normal distribution, the Dunnett-test (many to one t-test) based on a pooled variance estimate was applied for the comparison of the treated groups and the control groups.
The Steel-test (many-one rank test) was applied when the data could not be assumed to follow a normal distribution.
All tests were two-sided and in all cases p < 0.05 was accepted as the lowest level of significance.
Group means were calculated for continuous data and medians were calculated for discrete data (scores) in the summary tables.
Individual values, means, standard deviations and statistics were rounded off before printing. For example, test statistics were calculated on the basis of exact values for means and pooled variances and then rounded off to two decimal places. Therefore, two groups may display the same printed means for a given parameter, yet display different test statistics values
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no clinical signs of toxicity or behavioural changes over the 29 day observation period that were considered to be related to treatment.
Short periods of excessive salivation were noted in all males and females receiving 1000 mg/kg/ day. On 1 occasion, excessive salivation was also noted in 1/5 males receiving 200 mg/kg/day. Since this may be attributed to a possible irritant effect or bad taste of the test substance, it was considered not to represent a clear sign of toxicity. In addition, all treated animals showed dark appearance of the faeces from day 5 of treatment until termination. Considering the physico-chemical properties of CARTASOL BLUE PE 3562, colour changes were considered to be due to test substance that had not been absorbed in the gastro-intestinal tract.
Regurgitation of test substance was noted intermittently in al l animals receiving 1000 mg/kg/ day and incidentally in 2/5 males receiving 50 mg/kg/day and 1/5 females receiving 200 mg/kg/day. Since this phenomenon is very rare in rats and possibly may be associated with the above mentioned irritant effect of the test substance, it was considered not to be of toxicological significance. - Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Body weights and body weight gain of treated animals remained in the same range as controls over the 4 week study period.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- There were no differences in food consumption before or after allowance for body weight between treated and control animals.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- no effects observed
- Description (incidence and severity):
- There were no differences between the pretest examination and the examination at week 4 that could be attributed to treatment.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Haematological parameters of treated rats were considered not to have been affected by treatment.
A minor statistically significantly increased platelet value, for males receiving 50 mg/kg/day in comparison with control males, remained within the range normally expected for rats of this age and strain and was considered not to be of toxicological significance. - Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- There were no differences noted between control and treated rats that were related to treatment.
Statistically significantly low total protein and albumin values, noted among males receiving 1000 mg/kg/day when compared to control values, were within the range of normal biological variation for rats of this age and strain and considered to be of no toxicological significance. - Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- There were no behavioural changes over the 29 day observation period that were considered to be related to treatment.
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Organ weights and relative organ weights of treated animals were indistinguishable from those of control animals.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- The majority of animals receiving 50 or 200 mg/kg/day and all animals receiving 1000 mg/kg/day were noted with black appearance of the contents of small parts or the entire gastro-intestinal tract. There was no black appearance of gastro-intestinal tissue. This observation was not unexpected given the dark faeces noted clinically from day 5.
All other macroscopic observations at necropsy were within the range of normal background alterations and considered not to have arisen as an effect of treatment. - Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- NOEL (28 days): 1000 mg/kg/day
- Executive summary:
RATIONALE FOR DOSE LEVEL SELECTION: A 5-day range finding study was performed (with 3 rats/sex/group at dose levels of 50, 200 and 1000 mg/kg/day) to provide a basis for selection of dose levels for a study of longer duration.
Slightly low body weight gain was noted among females receiving 1000 mg/kg/day over the 5 days of treatment.
No differences of biological significance were observed in clinical appearance, food consumption, macroscopic appearance or l iver weights between the treated groups.
Based on these observations, a high treatment level of 1000 mg/kg/day was selected for a study of 28 days duration.
METHODOLOGY: In this subacute 28-day toxicity study, the test item was administered daily by gavage to SPF-bred Wistar rats. The study comprised of four groups.
The number of rats assigned to toxicity testing per group as well as the dose levels administered were as follows:
Group Dose level
mg/kgNo. of rats males females 1 0 1-5 21-25 2 50 6-10 26-30 3 200 11-15 31-35 4 1000 16-20 36-40 FINDINGS:
At 50 mg/kg/day: No treatment-related changes detected.
At 200 mg/kg/day: No treatment-related changes detected.
At 1000 mg/kg/ day: No treatment-related changes detected.
CONCLUSION: From the results presented in this report a definitive No Observed Effect Level (NOEL) of 1000 mg/kg/ day was established.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)