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EC number: 261-638-5 | CAS number: 59160-79-1
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
- Reference Type:
- publication
- Title:
- Preliminary Reproduction Toxicity Screening Test of Phthalocyanine Blue in Rats
- Author:
- Japan Existing Chemical Data Base (JECDB)
- Year:
- 2 009
- Bibliographic source:
- http://dra4.nihs.go.jp/mhlw_data/home/file/file147-14-8.html (original report is in Japanese; the web site was translated to English using the Google language tool http://www.google.de/language_tools?hl=de)
- Reference Type:
- secondary source
- Title:
- Final SIDS Initial Assessment Profile on C.I. Pigment Green 7 Copper, [tetradecachloro-29H, 31 H-phthalocyaninato(2-)-N{29},N{30},N{31},N{32}]
- Author:
- OECD
- Year:
- 2 005
- Bibliographic source:
- SIDS
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper
- EC Number:
- 205-685-1
- EC Name:
- 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper
- Cas Number:
- 147-14-8
- Molecular formula:
- C32H16CuN8
- IUPAC Name:
- [29H,31H-phthalocyaninato(2-)-kappa~2~N~29~,N~31~]copper
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Phthalocyanine Blue
- Analytical purity: 99.55 %
- Storage condition of test material: room temperature
- Structural formula attached as image file (if other than submission substance): see Fig.
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Japan
- Age at study initiation: 8 weeks
- Weight at study initiation: females: ca. 232 g; males: ca. 372 g
- Housing: bracket type metal wire mesh floor cages (260 x 380 x 180 mm)
- Diet: Feed-solid diet (CRF-1, Oriental Yeast Co, Ltd., Inc.), ad libitum)
- Water: tap water, ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature: 23 +- 3 °C
- Humidity: 55 +- 10 %
- Air changes: 10-15 times per hr
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- The test substance was dosed orally to male rats for 46 days included before mating and mating period, and to female rats from day 14 before mating to day 3 of lactation.
The test substance was administered into the stomach by gavage.
10 ml per kg body weight was calculated based on the weight - Details on mating procedure:
- According to OECD Guideline 421, 1:1 (one male to one female) matings were used. The female was placed with the same male until pregnancy occured or two weeks had elapsed. Each morning the females were examined for the presence of sperm or a vaginal plug. Day 0 of pregnancy was defined as the day a vaginal plug or sperm was found.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Administration period (males): from 14 days before mating, the mating period until copulation, and also 46 days after the start of copulation
Administration period (females): from 14 days before mating to day 3 of lactation
Duration of test: Males were killed on days 28 and 47, females on day 28 and on day 4 of lactation - Frequency of treatment:
- daily; administration time was between 10 h and 13 h.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 40 mg/kg bw/day (nominal)
- Remarks:
- The applied volume was 10 ml/kg bw/day for each dose; the respective concentrations of the test substance was 0.4 % (w/v).
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Remarks:
- The applied volume was 10 ml/kg bw/day for each dose; the respective concentrations of the test substance was 2 % (w/v).
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- The applied volume was 10 ml/kg bw/day for each dose; the respective concentrations of the test substance was 10 % (w/v).
- No. of animals per sex per dose:
- 12 animals per sex per dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Parental males were killed on days 28 and 47, parental females on day 28 and on day 4 of lactation
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: at least once every day visual inspection, observation of appearance and palpation
DETAILED CLINICAL OBSERVATIONS: reproductive capacity, the recording of occurrence of copulation and gestation, fertility, implantation, delivery and nursing indices, maternal behaviour, birth rate, pregnancy period
BODY WEIGHT: examination of body weight was conducted
FOOD CONSUMPTION: examination of feed intake was conducted
POST-MORTEM EXAMINATIONS: Organs were removed, reproductive organs were weighed
HISTOPATHOLOGICAL EXAMINATION: Ovaries, uterus, harderian gland, eyeball, mammary gland, spleen - Oestrous cyclicity (parental animals):
- examination of the oestrous cycle was conducted
- Litter observations:
- The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities, - Postmortem examinations (parental animals):
- POST-MORTEM EXAMINATIONS: Organs were removed, reproductive organs were weighed
HISTOPATHOLOGICAL EXAMINATION: Ovaries, uterus, harderian gland, eyeball, mammary gland, spleen, testes, epididymis (left and right) - Postmortem examinations (offspring):
- Post-mortem: The whole body was fixed in formalin solution
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- A blue coloration of faeces was noted in all animals of the groups receiving 40 mg/kg bw/day or more. These changes were due to the colour of the test substance
- Mortality:
- no mortality observed
- Description (incidence):
- No changes were observed in terms of mortality.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No changes were observed in terms of body weight.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No changes were observed in terms of food consumption.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No changes were observed in terms histopathological examination.
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effects were noted on the following endpoints: Reproductive ability of either sex (assessment of this endpoint included the examination of the oestrous cycle, the recording of occurrence of copulation and gestation, the calculation of copulation, fertility, implantation, delivery and nursing indices, the weight of testes and epididymis as well as histopathological examination of the reproductive organs), delivery, maternal behavior, viability, clinical signs and body weight changes.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related adverse effects observed up to the highest tested dose.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No findings were recorded with regard to general condition.
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- No findings were recorded with regard to survivability. The number of living and dead pups was not affected.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No findings were recorded with regard to body weights.
- Sexual maturation:
- no effects observed
- Description (incidence and severity):
- The sex of the pubs was not affected.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No findings were recorded with regard to autopsy (visual observation) of the pups. The external appearance were also not affected.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related adverse effects observed up to the highest tested dose.
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
The estimated NOAELs in this study were 1000 mg/kg bw/day for both the parental generation and for the F1 generation. Although premating exposure was relatively short for male animals in this screening test, the subchronic NOAEL of 200 mg/kg bw/day, also see in chapter 7.5 Repeated Dose Toxicity) was less than the fertility NOAEL of 1000 mg/kg bw/day herein. The test substance could therefore be considered as non toxic to fertility under the test conditions chosen, since actual exposure levels will clearly be less than the dose related to the NOAEL obtainedin the present study.
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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