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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 255-925-4 | CAS number: 42739-64-0
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 2014
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non GLP, but well documented.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
- Objective of study:
- other: distribution in plasma and liver
- Principles of method if other than guideline:
- Copper-content was determined in plasma and liver samples of rats that had been given gavage doses for 14 days at doses of 300 and 1000 mg/kg bw.
- GLP compliance:
- no
Test material
- Reference substance name:
- [[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper
- EC Number:
- 261-638-5
- EC Name:
- [[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper
- Cas Number:
- 59160-79-1
- IUPAC Name:
- 261-638-5
- Details on test material:
- Purity >= 97%
Batch no. 120001P040
Date of production: 13 March 2012
stability: unlimited
homogenity: given
appearance: solid, blue
storage conditions: ambient (room temperature); dry storage; protect against humidity
- Structural formula attached as image file (if other than submission substance): see Fig.
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld, Germany
- Age at study initiation: 42 +/- 1 days
- Weight at study initiation:
- Fasting period before study: none
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2014-06-09 To:2014-06-24
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: dnnkmg water containing 0.5% carboxymethylcellulose with about 5 mg/100 ml Cremophor EL
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Daily
The substance is a homogenous suspension. - Duration and frequency of treatment / exposure:
- 14 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
300 andd 1000 mg/kg bw
- No. of animals per sex per dose / concentration:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control reference chemical:
- A 14-day gavage study with an acid-labile copper-pigment (CAS 15680-42-9) was performed in the same year and this study showed a strong increase in liver copper content. (Plasma concentrations were not determined.)
- Details on study design:
- see endpoint study record for repeated dose toxcity
- Details on dosing and sampling:
- The determination of copper concentrations in EDTA plasma samples after were performed at the test facility.
The total concentrations of the test substance in plasma were calculated indirectly from the determined copper concentrations (inductively-coupled-plasma mass-spectrometry; experimental error + /- 0,2 mg/kg Cu).
This part of the study was carried out in compliance with the Principles of Good Laboratory Practice.
On study day 15, EDTA blood samples (about 200 μL) were collected from fasted animals by puncturing the retro-bulbar venous plexus under isoflurane anesthesia. After plasma preparation, the samples were frozen at about -80°C prior to analysis.
Liver samples were frozen at about -80°C prior to analysis.
Results and discussion
Main ADME results
- Type:
- other: distribution to liver and plasma
- Results:
- No increase in plasma and liver copper concentration was detected.
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- No increase in plasma and liver copper concentration was detected (see tables 1 and 2).
Metabolite characterisation studies
- Metabolites identified:
- not measured
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
- Executive summary:
Table 1: Copper content in liver samples
animal no. g liver mg Copper mg/g liver mean (n = 5) 1 2.043 0.011 5.38 5.54 males 2 2.021 0.011 5.44 control 3 2.2772 0.013 5.71 4 1.9791 0.012 6.06 5 1.9656 0.01 5.09 6 2.2573 0.014 6.20 6.01 males 7 1.63 0.01 6.13 300 mg/kg bw 8 1.5929 0.008 5.02 9 2.0888 0.012 5.74 10 2.0201 0.014 6.93 11 2.1328 0.011 5.16 5.31 males 12 1.9677 0.011 5.59 1000 mg/kg bw 13 1.2978 0.007 5.39 14 1.977 0.011 5.56 15 2.4663 0.012 4.87 16 1.3527 0.008 5.91 6.15 females 17 1.2401 0.008 6.45 control 18 1.2873 0.008 6.21 19 1.3878 0.008 5.76 20 1.2479 0.008 6.41 21 1.245 0.008 6.43 6.41 females 22 1.1989 0.008 6.67 300 mg/kg bw 23 1.3348 0.009 6.74 24 1.5306 0.009 5.88 25 1.2649 0.008 6.32 females 26 1.2009 0.007 5.83 6.16 1000 mg/kg bw 27 1.2749 0.009 7.06 28 1.2284 0.007 5.70 29 1.3773 0.008 5.81 30 1.2447 0.008 6.43 Table 2: Copper content in plasma samples
animal no. mg/kg mean 1 1 1.28 males 2 1.3 control 3 1.3 4 1.1 5 1.7 6 2.1 1.48 males 7 1.1 300 mg/kg bw 8 1.5 9 1.2 10 1.5 11 1.5 1.4 males 12 1.1 1000 mg/kg bw 13 1.5 14 1.4 15 1.5 16 1 1.18 females 17 1 control 18 1.3 19 1.1 20 1.5 21 1.5 1.4 females 22 1.1 300 mg/kg bw 23 1 24 1.5 25 1.9 females 26 1.3 1.52 1000 mg/kg bw 27 2.3 28 1 29 1.1 30 1.5
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.