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EC number: 253-256-2 | CAS number: 36888-99-0
- 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
key, oral, rat: LD50 > 10000 mg/kg bw; transient signs of toxicity: yellow dyed feces (non-GLP, similar to OECD 401; BASF SE, 1973)
read-across, CAS 76199-85-4, key, inhalative, rat: LC50 >5.42 mg dust/L air; signs of toxicity: no mortality and no toxicity observed (non-GLP, similar to OECD 403; BASF SE, 1982)
key, dermal, rat: LD50 > 2500mg/kg bw; transient signs of toxicity: no abnormality detected (non-GLP, similar to OECD 402; BASF SE, 1973)
supporting study, intraperitoneal, mouse: LD50 > 6400 mg/kg bw; signs of toxicity: no mortality; accelerated respiration, spastic gait and stretching, hunched body posture, closed eyes (non-GLP, non-guideline, BASF SE, 1973)
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
- 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 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (application volume exceeds 20 mL/kg bw, 7 day observation period)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Gassner
- Weight at study initiation: mean: males 214 g; females 186 g
ENVIRONMENTAL CONDITIONS
not reported - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- aqueous solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 % aqueous suspension in CMC solution
MAXIMUM DOSE VOLUME APPLIED:
33.3 mL/kg bw.
- Doses:
- 8000 and 10000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: Weighing was only performed at the beginning of the study for dose calculation. Observation of clinical signs was several times on the day of administration and once daily afterwards with the exception of weekends and on holidays.
- Necropsy of survivors performed: yes - Statistics:
- not performed
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality observed
- Clinical signs:
- other: no clinical signs observed
- Gross pathology:
- no abnormalities observed
- Other findings:
- yellow coloured faeces
- 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
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03.11.1981 - 17.11.1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- Pigment Yellow 185
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIGA Versuchstierzuchtanstalt, Sulzfeld, Germany, outbred strain: CAW-ICO-Wiga
- Age at study initiation: about 8 - 10 weeks
- Weight at study initiation: male animais 318 +/- 27 g, female animals 228 +/- 19 g
- Housing: five per cage, cages of Becker, type D III, without bedding.
- Diet: SSNIFF R complete diet for rats and mice, manufacturer: SSNIFF-Versuchstierdiaeten GmbH, Soest, Germany, ad libitum
- Water: tap water ad libitum during the observation period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature 22 +/- 2
- Humidity (%): 55 +/- 5
- Photoperiod (hrs dark / hrs light): 12 h/12 h - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Mass median aerodynamic diameter (MMAD):
- 1.7 µm
- Geometric standard deviation (GSD):
- 4
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Read-nose inhalation system INA 20 (glass-steel construction, BASF AG)
- Exposure chamber volume: 55 L
- Method of holding animals in test chamber: The animals are restrained in tubes and their snouts project into the inhalation chamber.
- Source and rate of air: 1500 L/h compressed air by the injector and 1500 L/h ventilator air as dilution air.
- System of generating particulates/aerosols: A mixture of dust and air was generated by means of dust metering equipment (BASF).
By means of a dust generator the substance to be tested was generated into a dust aerosol, which was passed into the inhalation system.
An automatic vibrator was used for dust generation. The concentration was adjusted by varying the apertural width and varying the amplitude of oscillations of the metering beaker.
- Method of particle size determination: Andersen Stack Sampler Mark III Millipore vacuum compressed air pump XX 60 220 50, limiting orifice 3 L/min, Millipore sampling probe, internal diameter 6.9 mm, 30 minutes after the beginning of the test at the earliest, one sample was taken for the particle size analysis. Before the sampling, the impactor was equipped with glass-fiber collecting discs and a backup particle filter.
The impactor was connected to the pump and the test apparatus, and one sample (9 L) was removed.
The impactor was taken apart, and the collecting discs and the backup particle filter were weighed. The contents of the pre-impactor were determined gravimetrically.
- Pressure in air chamber: 1500 L/h compressed air by the injector and 1500 L/h ventilator air as dilution air
- To ensure, that the mixture of the test substance and air was not diluted with fresh air, the air suction system was reduced about 10 % compared to the supply air system (excess pressure).
TEST ATMOSPHERE
- Brief description of analytical method used:
• Vacuum compressed air pump (Millipore) XX 60 220 50,
• Filtration equipment with probe (Millipore) (internal diameter: 4 mm),
• Filter: MN 85/90 Bf (d = 4.7 cm),
• Balance: Cahn 26
Gravimetric determination of the concentration: the preweighed filter was placed into a filtration equipment. By means of a vaccuum compressed air pump a volume of the dust aerosol characterized by a limiting orifice was drawn through the filter.
The dust concentration in mg/L was calculated from the difference between the preweight of the filter and the weight of the filter after sampling with reference to the sample volume.
- Samples taken from breathing zone: yes,
• Sampling: Velocity: 1.25 m/s, amount: 1 L, probe diameter: 4 mmm, frequency: half-hourly, in the immediate vicinity of the animal noses
- Particle size distribution: EACD 50% (effective aerodynamic cutoff diameter 50%);
Stage: Pre-impactor / EACD 50 % (µm): 26.6
Stage: Cascade impactor: Backup filter / EACD 50 % (µm): <1.2 / Percentage distribution (%): 41.14
Stage: Cascade impactor: 7 / EACD 50 % (µm): 1.2 / Percentage distribution (%): 18.69 / Cumulative distribution (%): 41.14
Stage: Cascade impactor: 5 / EACD 50 % (µm): 2.8 / Percentage distribution (%): 22.28 / Cumulative distribution (%): 59.83
Stage: Cascade impactor: 4 / EACD 50 % (µm): 5.5 / Percentage distribution (%): 8.40 / Cumulative distribution (%): 82.11
Stage: Cascade impactor: 3 / EACD 50 % (µm): 8.5 / Percentage distribution (%): 5.22 / Cumulative distribution (%): 90.51
Stage: Cascade impactor: 1 / EACD 50 % (µm): 18.2 / Percentage distribution (%): 2.14 / Cumulative distribution (%): 95.73
Stage: Cascade impactor: 0 / EACD 50 % (µm): 29.5 / Percentage distribution (%): 2.13 / Cumulative distribution (%): 97.87
A respirable dust fraction of 90.5% was obtained from the results of the particle size analysis.
- MMAD (Mass median aerodynamic diameter) 50 % = 1.7 µm/ GSD (Geometric st. dev.): 4.0 - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5.42 mg/l (analytical), 19.7 mg/l (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation, weighing; before start of application, then on day 7 and day 14,
- Necropsy of survivors performed: yes, with grosspathological examination.
- Other examinations performed: body weight - Statistics:
- The statistical evaluation of the concentrations-response relationship was carried out in accordance with the binomial test (Wittig, H.: Mathematische Statistik 1974, pp.32 - 35) using tables of the BASF Computer Center.
The particle size was determined in accordance with mathematical and graphical methods of evaluating particle measurements (Silverman, L.: Particle Size Analysis in Industrial Hygiene, 1971, pp. 235-259). - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.42 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: No mortality and no toxicity observed.
- Mortality:
- no mortality
- Clinical signs:
- other: During exposure: no abnormalities; After exposure: fur discolored by the test substance, particularly the region of the head; otherwise no abnormalities.
- Body weight:
- The body weight of the animals showed no adverse effects in comparison with that of the control.
Mean body weight (male / female)
- Before the study
Treatment group: 318 / 228
Control: 307 / 230
- After 7 days
Treatment group: 345 / 242
Control: 340 / 240
- After 14 days
Treatment group: 368 / 251
Control: 367 / 249 - Gross pathology:
- No abnormalities detected.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 5 420 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (occlusive treatment, 24 h exposure, incomplete documentation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- (occlusive treatment, 24 h treatment)
- 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:
- TEST ANIMALS
- Source: Wiga, Ottobrunn, Germany
- Weight at study initiation: mean weight: males 151 g, females 129 g
ENVIRONMENTAL CONDITIONS: not reported - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal, p.c., 50 cm²
- % coverage: > 10 %
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.5 g/kg animal
- Concentration (if solution): 50 % aequous solution
- For solids, paste formed: yes
- Duration of exposure:
- 24 h
- Doses:
- 2.5 g/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: No weighing was done. Observation was several times at the day of exposure and daily on working days.
- Necropsy of survivors performed: yes - Statistics:
- None
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality and no clinical signs were observed.
- Mortality:
- 0/10 animals died after the exposure
- Clinical signs:
- other: no abnormalities detected
- Gross pathology:
- 9/10 no abnormalities detected
1/10 right peak pulmonary lobe with chronic Bronchopneumonia - Other findings:
- - Other observations: after 24 h local orange substance residues
- 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
Additional information
There are reliable studies available to assess the acute oral and dermal toxicity of the test substance. The studies were performed in 1973 when characterization of powders in regard to particles with a size of < 100 nm was not routinely performed. Doses applied exceeded the maximum doses later prescribed in OECD testing guidelines. Retrospective analysis did not allow any conclusion on whether the test material was a a nanomaterial or not. However, organic pigments are all powders that often have a nanosize fraction. They consistently show absence of a hazard if tested up to the limit dose in studies with oral and dermal dosing (Stratmann, et al. Indicators for lack of systemic availability of organic pigments, https://doi.org/10.1016/j.yrtph.2020.104719, Regulatory Toxicology and Pharmacology Volume 115, August 2020, 104719). The publication lists 113 and 35 pigments tested for acute oral and dermal toxicity, respectively and in none of the studies, treatment-related morbidities were observed. Therefore, the available experimental data is considered adequate to assess the hazard of the pigment both in the bulk and in the nano form.
For acute inhalative toxicity there is only an acute toxicity study available for for the analogous test substance CAS 76199-85-4. In general support of read-across, all acute studies for PY 185 are listed in the table and provided as robust study summaries.
Oral
A study was performed to assess the acute toxicity following oral administration of the test substance in rats similar to OECD guideline 401 with deviations (BASF SE, 1973). To a group of five animals per sex and per dose a single oral dose of the test material preparation (dose volume: 20 ml/kg bw) in an aqueous solution of carboxymethyl cellulose at a dose level of 8000 and 10000 mg/kg bw was given. The animals were examined for clinical signs several times on the day of administration and once daily afterwards with the exception of weekends and on holidays. The observation period was 7 days instead of 14 days as recommended in OECD 401. Surviving animals were necropsied at the end of the study. No clinical signs were observed during the study. Only yellow colored feces were noticed. All animals survived until the end of the study period. At necropsy no abnormalities were observed.
Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 10000 mg/kg body weight for male and female rats.
Inhalative:
In a study evaluating acute toxicity following inhalative administration Sprague-Dawley rats were exposed to the analogous test substance CAS 76199-85-4 according to OECD guideline 403 without deviations (BASF 1982). Five male and female animals were exposed to 5.42 mg/l (analytical) test substance in a head-nose inhalation system for 4 hours. The MMAD 50% (mass median aerodynamic diameter 50%) was 1.7 µm, calculated from the results of the particle size analysis and the respirable dust fraction was calculated to be 90.5%. During the observation period of 14 days, the animals were examined for clinical signs daily and then necropsied with gross pathological examination at the end of the observation period. No mortality was observed during the course of the study. No clinical signs were observed during the study period. Only the fur was discolored by the test substance, particularly the region of the head.
Under the conditions of this study the median lethal concentration of the test substance after inhalative exposure was found to be greater than 5.42 mg dust/L air for male and female animals.
Dermal
A study was performed to assess the acute toxicity following dermal administration of the test substance in Sprague-Dawley rats similar to OECD guideline 402 with deviations (BASF SE, 1973). Five animals per sex were treated with the test substance at 2500 mg/kg bw by dermal occlusive application. The test item was diluted in vehicle (an aqueous solution of carboxymethyl cellulose) at a concentration of 50%. The application period was 24 hours. During the observation period of 14 days, the animals were examined for clinical signs several times on the day of exposure and daily afterwards on working days. All animals survived and no clinical signs were observed during the study period. In nine of ten animals no abnormalities were detected at necropsy. In only one of ten animals right peak pulmonary lobe with chronic Bronchopneumonia was observed in gross pathology.
Under the conditions of this study the median lethal dose of the test substance after dermal application was found to be greater than 2500 mg/kg body weight for male and female animals.
Intraperitoneal:
A non guideline study was performed to assess the acute toxicity following single intraperitoneal administration of the test substance in mice (BASF 1973). In that supporting study animals were treated with the test substance in the doses 3200 and 6400 mg/kg bw in a 30% aqueous solution with carboxymethyl cellulose as vehicle. During the observation period of 7 days, the animals were examined for clinical signs. Dyspnea and spastic gait were observed. All animals survived until the end of the study period. Therefore, the approximative median lethal dose is > 6400 mg/kg bw. At necropsy intraabdominal deposits of test substance and slightly colored organs were observed.
Under the conditions of this study the approximative median lethal dose of the test substance after single intraperitoneal application was found to be greater than > 6400 mg/kg body weight for male and female animals.
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. No mortality occurred at the limit dose of 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 fourteenth time in Regulation (EC) No. 2020/217.
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