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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 947-892-6 | CAS number: -
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- genetic toxicity in vivo, other
- Remarks:
- Dominant lethal test
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
- Deviations:
- yes
- Remarks:
- No positive controls used; 3 separate studies performed
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP regulations
- Type of assay:
- rodent dominant lethal assay
Test material
- Reference substance name:
- Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
- EC Number:
- 307-259-1
- EC Name:
- Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
- Cas Number:
- 97592-62-6
- Molecular formula:
- not available
- IUPAC Name:
- Aluminum, hydroxy[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chloro sulfo derivs., sodium salts
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Name as used in the study report: FAT 60 149/B
Test animals
- Species:
- mouse
- Strain:
- Tif:MAGf
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: closed SPF breeding colony
- Age at study initiation: 2-3 months
- Weight at study initiation: 28-53 g
- Diet: standard laboratory diet (NAFAG No.890)
- Water: ad libitum:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 34-78
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Polyethylene glycol 400
- Details on exposure:
- The substance was administered orally by intubation in single doses of 666 and 2000 mg/kg to each 20 males. The control group was treated with the vehicle only. The females remained untreated.
- Duration of treatment / exposure:
- Singe doses
- Frequency of treatment:
- Once
- Post exposure period:
- 6 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 666 mg/kg bw (total dose)
- Dose / conc.:
- 2 000 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 20 males
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- no
Examinations
- Details of tissue and slide preparation:
- The number of live embryos and embryonic deaths were listed. In addition, the uteri were placed in a solution of ammonium sulphide in order to detect sites of early embryonic resorptions.
- Statistics:
- To compare the totals of the number of implantations indicating possible pre-implantation losses - the t-test or Mann-Whitney's U-test was used. The totals of the numbers of mated.and pregnant dams or embryonic deaths were compared with the aid of the Χ2-test or - Fisher's exact test.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Additional information on results:
- In the first study, the date on the mating ratio and the number of implantations were comparable in all groups. The data on embryonic deaths showed a statistically significant increase in the high-dose group in the second (14.5%) and the third (16.3%) mating periods in comparison to the respective controls (7.5% and 6.9%) (p<0.01). In the second study, the findings made in first study were not reproduced. In this study, in the second mating period, there was a statistically significant increase in the number of embryonic deaths in the low-dose group in comparison with the control (10.8%; control 4.9%) (p<0.01). In addition, a statistically significantly lower rate of pregnancies was found in the control group (69.2%) during the third period, in comparison with the respective treatment groups (>90%). In the third study, the statistically significant finding made in both, the 1 and the 2 study were not reproduced. In this study, only in the low-dose group during the first period was a lower number of implantations (mean value 9.84) found than in the controls (mean value 11.1).
Since the deviations observed in the three studies were each only reproducible on the individual investigations and not in one or both of the others, they can be regarded as purely fortuitous and the results in their entirety therefore cannot be interpreted as evidence of dominant lethal effects in the progeny of male mice treated with the test substance.
Applicant's summary and conclusion
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.