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EC number: 270-099-5 | CAS number: 68411-06-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
This UVCB substance is assessed as non hazardous for acute toxicity from experimental data in rats with another UVCB substance consisting of identical components. Both UVCB substances are poorly soluble nanomaterials.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Higher doses tested; only 7 day observation period.
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Mean body weight: males 241 g, females 176 g
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- Suspension in 0.5% aqueous CMC solution
Test concentration used: 35% - Doses:
- 4640 and 10000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: Partly feces dark-blue coloured
- Gross pathology:
- Nothing abnormal detected
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 10 000 mg/kg bw
- Quality of whole database:
- Klimisch 2
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- It is referred to the attached document.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Species:
- rat
- Route of administration:
- inhalation: dust
- Sex:
- male/female
- Dose descriptor:
- discriminating conc.
- Effect level:
- 2 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 2 mg/m³ air
- Physical form:
- inhalation: dust
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- according to D.N. Noakes and D.M. Sanderson: A Method for Determining the Dermal Toxicity of Pesticides; Brit. J. Ind. Med. 26, 59 (1969)
- Deviations:
- yes
- Remarks:
- higher dose; body weight not reported.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Mean body weight: males 148 g, females 131 g
- Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- A 50% test substance concentration was used.
- Duration of exposure:
- 24 hours
- Doses:
- 2500 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Application area: 50 cm2
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Mortality:
- None
- Clinical signs:
- other: During and after application as well as after the 14-day observation period, the animals were brisk. Local findings after 24 hours: all animals blue test substance residues, reddening not visible. Local findings after 8 days: light-blue substance residues
- Gross pathology:
- Nothing abnormal detected
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 500 mg/kg bw
- Quality of whole database:
- Klimisch 2
Additional information
The substance itself was not tested for acute toxicity. Experimental data is available for the analogue UVCB substance CAS 559160 -79 -1 which only differs from the target substance by an higher average degree of substitution and consists of the same components. For more information supporting the read-across it is referred to the attachment in the toxicokinetic section. It includes data matrices and chemical structures.
The experimental data
for the analogue UVCB substance CAS 559160 -79 -1
were generated prior to the introduction of GLP and OECD testing guidelines. Study reports containing adequate description of the experimental procedure and results and with adequate identification of the test substance are available.
The protocol for acute oral toxicity differs from the OECD testing guideline by the shorter observation period (7 instead of 14 days) and by a five-fold higher dose (10000 instead of 2000 mg/kg bw) (BASF 1976). Considering the lack of toxicity observed under these testing conditions, the study is considered to provide sufficient information despite the shorter oberservation period. Blue discoloration of the feces indicated passage of the blue colorant through the gastrointestinal tract.
The protocol for acute dermal toxicity differs from OECD testing guideline 402 by a higher dose of 2500 mg/kg bw. No systemic toxicity was observed during the 14 -day observation period. As the test item coloured the application site, local effects could only be partly assessed during the first part of the study. Then later no local effects were noted.
An acute inhalation study with poorly characterized dusty material in rats was performed (BASF 1976). The test atmosphere was generated by blowing air through a layer of the test material and the concentration was calculated from the weight difference of the layer of the test material. During the 8h exposure, an average concentration of ca. 5mg/L was applied. No particle size characterization and no online concentrations are available, therefore the study is only indicative. No rat died as a consequence of treatment.
A more recent acute inhalation toxicity study in rats with a phthalocyanine nanomaterial was performed in 2021.To determine the acute inhalation toxicity (single 4-hour exposure, nose only) of 29H,31Hphthalocyanine as a dust, a study was performed in male and female Wistar rats according to OECD-Guideline method 403, as well as EC and EPA guidelines (BASF 2021). The test was run with an actual measured concentration of 2.046 mg/L (analytical concentration).
Cascade impactor measurements resulted in particle size distributions with mass median aerodynamic diameters (MMADs) of 2.67 and 2.58 μm, which are well within the respirable range.
One of the five males died at 2.046 mg/L on study day 0 during exposure. The death was determined in the 2nd hour of the exposure. No mortality was observed in female animals. Clinical signs of toxicity in animals comprised abdominal and intermittent respiration, respiration sounds, hunched posture, piloerection, substance-contaminated and discolored fur substance like. Findings were observed from hour 1 of exposure until the end of the 14-day post-exposure observation period. The mean body weights of the surviving animals decreased on the first post-exposure observation day but increased thereafter. This is a typical finding for this test design. Gross necropsy of the male animal that died on study day 0 showed blue discoloration of the fur on the entire body. During necropsy of the surviving animals at the termination of the post-exposure observation period the following gross pathological findings were noted: many blue foci in all lung lobes, grey/blue discoloration of the mediastinal lymph nodes and blue discoloration of the fur of the tail and/or head region. To further evaluate the macroscopic findings, histopathological examination was carried out of the respiration tract from the male animal No. 721 which died on study day 0. Minimal amount of green-blue crystals revealing the presence of the test substance were seen in the lumen of the larynx, pharynx and nasal cavity. Furthermore, in the larynx, slight grey granular material in the lumen and a slight edema in the region of the ventral pouch were noted. All these findings are regarded as treatment-related, however they are not considered relevant enough to explain the death of this animal.
Under the current study conditions, the LC50value was > 2.046 mg/L in male and female Wistar rats after a 4-hour inhalation exposure to the dust aerosol of 29H,31H-phthalocyanine.
In addition,for the analogue UVCB substance CAS 559160 -79 -1
a study with intraperitoneal application of 2000 mg/kg bw is available (BASF 1976). No animal died during the 8 -day observation period.
In all studies, effects were clearly absent and far away from any threshold of classification and labelling. There is no uncertainty of read-across arising from the nature or the severety of the effects.
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The LD50 is greater than 2000 mg/kg bw. As a result the substance is not considered to be classified for acute oral or dermal toxicity under Regulation (EC) No. 1272/2008, as amended for the fifthteens time in Directive EC 2020/1182.
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.
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