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Diss Factsheets
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EC number: 235-476-0 | CAS number: 12239-87-1
- 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:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- ; no clinical chemistry, hematology, or urinalysis were conducted and no organ weights were taken (as recommended in OECD Guideline 408).
- GLP compliance:
- no
- Limit test:
- no
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Pigment Green 7, C.I. 74260
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Phthalocyanine Green 7
- Analytical purity: 97.8 %
Green 7 (Phthalocyanine Green) manufactured by Dry Color Manufacturers' Association, was obtained from Midwest Research institute on March 28, 1978. The elemental analysis pcrfortied at Midwest Research Institute was low for copper and nitrogen, slightly low for carbon, and slightly high for hydrogen and chlorine; values for all determined elements totaled 97.8 percent.
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Harlan Industries
- Age at study initiation: 8.5 weeks
- Weight at study initiation: males: 20 - 24 g; females: 15 - 18 g
- Housing: polycarbonate cages: groups of 5 mice per cage
- Diet: weighed portions of Purina Lab Chow in meal form, mixed together with weighed portions of the test material (see details at "doses/concentrations")
- Water: ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23 °C
- Humidity: 40 - 60 %
- Air changes: at least 15 per hour
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Dose levels of 5.0, 2.5, 1.25, 0.6 and 0.3 % (w/w) were selected for both males and females. The selected doses were prepared by mixing weighed portions of purina Lab Chow in meal form with weighed portions of the test material. 12 % water was added to the test material as a dust control agent prior to mixing with the meal. For each dose level, one weekly lot of 4500 g (+ 12 % water compensation) was prepared.
The actual mixtures were composed of the following ingredients:
- Dose level 5.0 % (w/w): 225 g test material and water + 4275 g meal
- Dose level 2.5 % (w/w): 112.5 g test material and water + 4387.5 g meal
- Dose level 1.25 % (w/w): 56.25 g test material and water + 4443.75 g meal
- Dose level 0.6 % (w/w): 27 g test material and water + 44735 g meal
- Dose level 0.3 % (w/w): 13.5 g test material and water + 4486.5 g meal
Each diet was mixed in a Patterson-Kelly twin shelled V blender for 15 min.
The doses were mixed one or two days prior to the week of their use in the study, and stored at 23 °C. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- One analysis was perfomed to determine the accuracy of the mixture concentration. Results were within +- 10 % of the desired dose concentration.
- Duration of treatment / exposure:
- 91 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.3 other: % in the diet
- Dose / conc.:
- 0.6 other: % in the diet
- Dose / conc.:
- 1.25 other: % in the diet
- Dose / conc.:
- 2.5 other: % in the diet
- Dose / conc.:
- 5 other: % in the diet
- No. of animals per sex per dose:
- 10 males and 10 females per dose
- Control animals:
- yes, plain diet
- Details on study design:
- - 10 animals were used per sex and dose group.
- Five dose levels of 0.0, 0.3, 0.6, 1.25, 2.5 and 5.0 % in feed were used in this study (approx. 0, 1000, 2000, 4000, 8000 or 16000 mg/kg bw/day for males, [based on 8.2 g/d average food consumption, 0.026 kg average bw] and approx. 0, 1200, 2500, 5000, 10000 and 20000 mg/kg bw/day for females [based on 7.7 g/d average food consumption, 0.019 kg average bw]).
- The selected doses were prepared by mixing together weighed portions of Purina Lab Chow in meal form with weighed portions of the chemical.
- Each dosed group received dosed feed mixture on 91 consecutive days.
Examinations
- Observations and examinations performed and frequency:
- Animals were observed twice each day for clinical signs, with at least 6 hours between observations. All clinical signs were recorded daily. Additional studies included blood sampling for the animal disease screening program from 10 control mice, 5 males and 5 females.
- Sacrifice and pathology:
- Mice were necropsied on day 92 and 93.
- Gross examination were performed on all animals from all dosage groups.
- Microscopic examinations were performed on following organs from all animals in the control group and the highest dose treatment group: Kidney, liver, lung, heart, epididymis, stomach, thyroid, skin (only in control group: bone marrow, urinary bladder, testis). - Other examinations:
- Copper analyses were completed in the liver and kidney tissues and the formalin preserving those tissues from male mice in the highest dose group (5 % w/w) and control groups. See details and results in endpoint "7.1.1. Basic toxicokinetics"
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment related abnormal clinical signs were observed.
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- 4 deaths occurred during the study; 3 males at 1.25 % and 1 control male. These deaths were not considered to be test substance related. There were no early dead females during the course of the study.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A -9 % to +8 % differential weight gain was seen in the dosed females. Animals in the highest dose levels had less weight gain than controls. However, given the normal variability in mouse body weight measurements, this differences did not necessarily reflect a manifestation of toxicity. Dosed male mouse groups showed a positive weight differential in all groups except the 0.6 % dosage group. In this group during week 12 with a corresponding weight loss was observed, which was not fully recovered during the final week of the study.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- There were no trends in diet consumption among dosed animals compared with controls in either male or female mice. Average daily consumption
among male mice dosed groups and controls ranged from 7.6-9.5 g; female mice dosed groups and controls ranged from 7.5 to 7.8 g. While male ranges were somewhat erratic, there was no indication of dose-related effects. - Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No substance related changes were reported on macroscopic and microscopic examination of the animals. Gross examination were performed on all animals from all dosage groups.
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No substance related changes were reported on macroscopic and microscopic examination of the animals. The microscopical lesions found were encountered in both the control and experimental high dose group with similar frequency and severity.
- Details on results:
- A dosage level of 5 % and 2.5 % was recommended to be used test substance in the chronic study, due to lack of compound-related lesions.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 16 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: absence of effects
- Remarks on result:
- other: calculated from dietary concentrations
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 20 000 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: absence of effects
- Remarks on result:
- other: calculated from dietary concentrations
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Although this study does not determine all parameters required by OECD guideline 408, it convincingly shows absence of systemic via the lack of accumulation of copper in liver and kidney after 90 day feed application. It therefore serves as key study for the endpoint of subchronic oral toxicity.
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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