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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Administration from day 6 until day 15 of pregnancy.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- Administration only during day 6-15 of pregnancy
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP regulations
- Limit test:
- no
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 study report: FAT 60 149/B
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: closed breeding colony (CIBA-GEIGY, WST)
- Age at study initiation: 2 months
- Weight at study initiation: approximately 200 g
- Housing: in groups of 5 in Macrolon cages
- Diet: standard cube diet (Nafag No. 890 Tox), ad libitum
- Water: ad libitum
- Acclimation period: 7-14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 1
- Humidity (%): 60 ± 5
- Photoperiod (hrs dark / hrs light): 14/10
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 2% aqueous solution of a sodium carboxymethylcellulose
- Details on exposure:
- - Preliminary study: 2 groups of 10 females were administered either vehicle control or 1000 mg/kg
- Main study: 4 groups of 25 females were administered vehicle control, 100 mg/kg, 300 mg/kg or 1000 mg/kg
The amount of fluid administered was 1 ml/100 g of body weight. The suspension of test material was freshly prepared daily by homogenizer and magnetic stirrer. - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Females were mated over night with males of proven fertility in the ratio of 1 male: 3 females. The day on which spermatozoa were found in the vaginal smear or a vaginal plug was observed, was designated as day 0 of pregnancy.
- Duration of treatment / exposure:
- day 6 to 15 of gestation
- Frequency of treatment:
- Once per day
- Duration of test:
- Termination at day 21 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- vehicle control
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 300 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- - preliminary study: 10 females
- main study: 25 females treated (22-25 pregnancies per group) - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Dams were killed and fetuses removed by caesarean section on day 21 of pregnancy.
Examinations
- Maternal examinations:
- - general condition, daily
- body weight gain, daily
- symptoms, daily
- food consumption, days 6, 11, 16 and 21 of gestation
- gross examination of organs - Ovaries and uterine content:
- - mucosa, amniotic fluid and placentae
- total implantations, embryonal resorptions, foetal resorptions
- examination of uteri without any visible implantation by ammonium sulfide staining
- gravid uterus weight - Fetal examinations:
- - live foetuses, dead foetuses, total litter size
- foetal weight
- sex ratio
- skelet (two-thirds of foetuses)
- soft tissues (one-thirds of live foetuses)
- external malformations - Statistics:
- -chi-square test, Yates correction
- Historical control data:
- Yes, for skeletal malformations
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One female in the mid-dose group developed inflammation of the thoracic region, induced by an intubation error
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The body-weight gain was generally comparable for all groups.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- The food consumption was generally comparable for all groups.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- The implantation rates were comparable for all groups
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- no effects observed
- Description (incidence and severity):
- By the comparison to the vehicle control, the rates of of embryolethality and foetolethality (resorptions) were not increased (chi-square test, Yates correction, P ≤ 0.01)
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- Three dead foetuses in the mid-dose group (300 mg/kg), of which two in the same litter. No dead foetuses in any other group
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- 22/25 pregnant rats in both the vehicle control group and the mid-dose group (300 mg/kg), 25 pregnant rats in the low dose group (100 mg/kg) and high dose group (1000 mg/kg).
Effect levels (maternal animals)
- Key result
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- The average weight of the live foetuses was comparable for all groups
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): The average weight of the live foetuses was comparable for all groups - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- The sex ratios (expressed as % male foetuses) were comparable for all groups.
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One multiple malformation was recorded for one foetus each of the 100 mg/kg and 1000 mg/kg dose group.
- 100 mg/kg group: Multiple malformation : hydrocephaly, hypognathia, " open eyes" (unilat.) , oedema, coelosomia, oligodactyly of fore-limbs (associated with ectromelia) , "pes varus" of right hind-limb
- 1000 mg/kg group: Multiple malformation : agnathia, "open eyes", coelosomia, oedema, amelia (left fore and hind-limb), brachymelia (right fore-limb ), ectromelia (right hind-limb ) - Skeletal malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Next to the skeletal malformations seen in the multiple malformations:
- The skeletal assessment of the foetuses revealed irregular ossification of sternebrae in one foetus each of the 100 mg/kg and 300 mg/kg dose group and two foetuses from one litter of the 1000 mg/kg dose group.
- By comparing the skeletal maturation of the foetuses of the experimental groups on the basis of the 99% confidence limits determined for the vehicle control, there was found an increase in the number of still unossified phalangeal nuclei of the hind-limb at 1000 mg/kg as well as calcaneus at 300 mg/kg and 1000 mg/kg. - Visceral malformations:
- no effects observed
- Description (incidence and severity):
- No visceral abnormalities were noted in either the experimental groups or the vehicle control
- Details on embryotoxic / teratogenic effects:
- The slight delay of physiological growth encountered in the foetuses from mothers treated at doses of 300 mg/kg and 1000 mg/kg is considered to be of a non-specific nature, and of doubtful experimental significance.
Effect levels (fetuses)
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
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.
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