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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
Endpoint summary
Administrative data
Description of key information
The study is practically non-toxic in rats after single ingestion and dermal application. An inhalation study performed with poorly characterized dust did not show acute inhalation toxicity.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non GLP, prior to OECD guidelines. Design and reporting details adequate.
- 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.
- Principles of method if other than guideline:
- according to BASF-internal standard
- 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
- 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:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1976
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Principles of method if other than guideline:
- Animals are exposed to dust generated by blowing air through a layer of the test material
- GLP compliance:
- no
- Test type:
- fixed concentration procedure
- Limit test:
- yes
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Mean body weight: 191 g
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetrically
- Duration of exposure:
- 8 h
- Concentrations:
- 5.95 mg/l
- No. of animals per sex per dose:
- 12
- Control animals:
- other: air control
- Details on study design:
- Particle size distribution not determined. The concentration of the test material in the air was calculated from the volume of blown air and the difference in the weight of the test material layer before and after the study.
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- >= 5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 8 h
- Remarks on result:
- other: Particle size distribution unknown
- Mortality:
- None
- Clinical signs:
- other: Slight mucosal irritation
- Gross pathology:
- Nothing abnormal detected
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- > 5 mg/m³ air
- Physical form:
- inhalation: aerosol
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non GLP, prior to OECD guidelines, design and reporting details adequate
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- higher dose; body weight not reported.
- Principles of method if other than guideline:
- 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)
- 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 experimental data on acute toxicity 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 not be completely 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.
For additional information, an acute inhalation study with phthalocyanine (OECD 403, GLP, BASF 2021) was taken into account. Particle characterization confirmed that the material was a nanomaterial. At the limit dose of 2 mg/L of dust, one of ten rats died during the 4h exposure period. No indication of systemic toxicity was observed at necropsy at the end of the observation period.
In addition, a study with intraperitoneal application of 2000 mg/kg bw is available (BASF 1976). No animal died during the 8 -day observation period.
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. As a result, the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008, as amended for the thirteenth time in Regulation (EC) No. 2018/1480.
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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