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EC number: 248-236-5 | CAS number: 27121-30-8
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study meets requirements of OECD 401, Directive 92/69/EEC, B.1 and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- [29H,31H-phthalocyaninetrisulphonyl trichloridato(2-)-N29,N30,N31,N32]copper
- EC Number:
- 248-236-5
- EC Name:
- [29H,31H-phthalocyaninetrisulphonyl trichloridato(2-)-N29,N30,N31,N32]copper
- Cas Number:
- 27121-30-8
- Molecular formula:
- C32H13Cl3CuN8O6S3
- IUPAC Name:
- Copper, [29H,31H-phthalocyanine-C,C,C-trisulfonyl trichloridato(2-)-kN29,kN30,kN31,kN32]-
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain specifics: Hoe: WISKf (SPF71)
- Source: Hoechst AG, breeding colony, SPF-breed
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: male 173 g - 185 g (mean 177 g), female 168 g - 177 g (mean 170 g)
- Fasting period before study: approximately 16 hours before to 3-4 hours after treatment, access to water permitted
- Housing: in groups of five in Makrolon type 4 cages with standard softwood bedding
- Diet (e.g. ad libitum): standard rat diet (Altromin 1324) ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: deionized water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % (w/v)
- Amount of vehicle (if gavage): 10 mL/kg body weight (test item in vehicle administered)
- the test item was dissolved in deionized water and distributed homogenously by magnetic stirring. Stability and homogeneity of the solution was analytically approved for 4 h. - Doses:
- 2000 mg/kg body weight (corresponding to 830 mg/kg body weight of the substance which is subject to registration)
- No. of animals per sex per dose:
- 5 males
5 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-- mortality/viability: during the first 30 minutes and approximately 1, 2, 4, and 6 h after administration on day 1 and twice daily (once on weekends) on days 2-14.
-- clinical signs: during the first 30 minutes and approximately 1, 2, 3 and 6 h after administration on day 1 and and twice daily (once on weekends) on days 2-14.
-- ody weights: prior to administration), 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination - Statistics:
- None
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 830 mg/kg bw
- Based on:
- other: substanct subject to registration
- Remarks on result:
- other: content of the substance subject to registration in the test sample was 41.5%
- Mortality:
- no deaths
- Clinical signs:
- other: After applilcation squatting posture, stilted gait and irregular respiration were observed. 8 hours after administration all clinical signs were reversible. The feces were discoloured black up to day 2 of the study.
- Gross pathology:
- No macroscopically visible changes at scheduled necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the findings in this study the test item and the substance subject to registration have not to be classified according to Regulation (EC) No 1272/2008.
- Executive summary:
One group of five male HoeWISK (SPF71) rats and one group of five female HoeWISK (SPF71) rats were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (deionized water) at a concentration of 20 % (w/v) and administered at a volume dosage of 10 mL/kg bw.
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs at approximately 30 minutes, 1, 2, 4 and 6 hours after treatment on day 1 and twice daily during test days 2-14. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 4 and 6 hours after administration on test day 1 (with the clinical signs) and daily during days 2-14. Body weights were recorded prior to administration and on days 7 and 14. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study period.
The following clinical signs were observed: squatting posture, stilted gait and irregular respiration. Eight hours after application all clinical signs were reversible. Additionally, black discolored feces were observed up to day two of the study.
No macroscopic findings were recorded for the animals at scheduled necropsy.
The median lethal dose of the test item after single oral administration to male and female rats, observed over a period of 14 days is:
LD50 (male/female rat): greater than 2000 mg/kg body weight
Due to the fact that the content of the substance which is subject of registration in the test sample was 41.5% and dose formulations were prepared without adjustment the maximum dose level tested was 830 mg/kg body weight. Thus the resulting median lethal dose is:
LD50 (male/female rat): greater than 830 mg/kg body weight
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