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EC number: 309-916-8 | CAS number: 101357-19-1
- 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
LD50, rat, oral, (m/f) > 2000 mg/kg OECD 401, limit test
LC0, inhalation, > 6.51 mg/l, OECD 403
LD50, dermal > 2500 mg/kg, OECD 402
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:
- November 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Manston, Kent, U.K.
- Age at study initiation: five to eight weeks old
- Weight at study initiation: 142 - 177 g
- Fasting period before study: overnight
- Housing: in groups of up to five by sex in solidfloor polypropylene cages furnished with woodflakes
- Diet: Rat and Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, Essex, U.K ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21°C
- Humidity (%): 45 - 54%
- Air changes (per hr): approximately 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle: 10 mL/kg
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg - Doses:
- 1
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 0.5, 1, 2, 4h, and each day until day 14
- Frequency of weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes - Preliminary study:
- Of two tested animals (male and female) at 2000 mg/kg bodyweight no signs of systemic toxicity were noted, the staining of the fur and the faeces were blue-coloured from 4 h up to 3 days.
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: Dark blue-coloured liquid discharged from the anus was noted in all animals four hours after dosing. Dark blue-coloured staining of the fur was commonly noted. All animals recovered one day after dosing.
- Gross pathology:
- no abnormalities
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline compliant study.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: H.F. Smyth et. aI .: Am. Ind. Hyg. Ass. J. 23, 95-107 (1962)
- GLP compliance:
- no
- Test type:
- fixed concentration procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
For the enrichment 200 L air/h were ducted through a 5 cm layer of the test substance. The mean concentration was calculated to be 6.51 mg/L
FORM AS APPLIED IN THE TEST
solid - Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: 547 - 822 g
ENVIRONMENTAL CONDITIONS
not specified - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 7 h
- Concentrations:
- calculated concentration: 6.51 mg/L
- No. of animals per sex per dose:
- 6
- Control animals:
- not specified
- Details on study design:
- - Observation period following administration: no
- Frequency of observations: 3, 10, 30 min, 1, 3, 7h
- Necropsy of survivors performed: yes
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- 6.51 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 7 h
- Mortality:
- no mortality
- Clinical signs:
- other: no abnormalities
- Body weight:
- not specified
- Gross pathology:
- no results
- Other findings:
- Purple staining of the fur by the test substance was observed throughout the study period.
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- no
- Test type:
- fixed concentration procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
For the enrichment 200 L air/h were ducted through a 5 cm layer of the test substance. The mean concentration was calculated to be 7.53 mg/L
FORM AS APPLIED IN THE TEST
solid - Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Mean weight at study initiation: 157 g
ENVIRONMENTAL CONDITIONS
not specified - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 8 h
- Concentrations:
- calculated concentration: 7.53 mg/L
- No. of animals per sex per dose:
- 6
- Control animals:
- yes
- Remarks:
- air control
- Details on study design:
- - Observation period following administration: yes, one week
- Frequency of observations: 3, 10, 30 min, 1, 3, 8h
- Necropsy of survivors performed: yes - Key result
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- 7.53 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 8 h
- Mortality:
- no mortality
- Clinical signs:
- other: slight mucosal irritations
- Body weight:
- not specified
- Gross pathology:
- no results
- Other findings:
- Purple staining of the fur by the test substance was observed throughout the study period.
- Interpretation of results:
- GHS criteria not met
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 6.51 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
- Study period:
- 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- other: D.N.Noakes & D.M.Sanderson (A Method for Determining the Dermal Toxicity of Pesticides; Brit. Journ. Ind. Med. 26, 59, 1969)
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- 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
- Weight at study initiation: 107 - 152 g
- Housing: not specified
ENVIRONMENTAL CONDITIONS
not specified - Type of coverage:
- not specified
- Vehicle:
- water
- Remarks:
- aqua dest.
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back, 50 cm²
- % coverage: not specified
- Type of wrap if used: not specified
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 2500 mg/kg
- Concentration: 50 % - Duration of exposure:
- 24 h
- Doses:
- 2500 mg/kg
- 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: 1, 24, 48 h, 7, 14 days
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- other: no results
- Gross pathology:
- no results
- Other findings:
- Purple remains of the test substance were observed throughout the study period.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 500 mg/kg bw
Additional information
VIA ORAL ROUTE:
KEY: Acute oral toxicity (Ferro, 1993)
In an acute oral toxicity study performed according to OECD 401, a fixed concentration of 2000 mg/kg bw of Pigment Violet 3 PTM was administered by gavage to five fasted Sprague-Dawley rats each. The following test substance-related clinical observations were recorded, clinical signs occurred within the first 14 days after administration:
2000 mg/kg: No mortality in all animals; good general state in all animals;
Dark blue-coloured liquid discharged from the anus was noted in all animals four hours after dosing. Dark blue-coloured staining of the fur was commonly noted. All animals recovered one day after dosing. All animals showed expected gain in bodyweight during the study except for one male which showed a reduced gain in bodyweight during the second week. No abnormalities in macroscopic pathological findings.
The acute oral LD50 was calculated to be LD50, oral, rat > 2000 mg/kg bw.
SUPPORTING: Acute oral toxicity (BASF, 1980)
In an acute oral toxicity study (equivalent or simlar to the method described in OECD guideline 401) five male and 5 female Sprague-Dawley rats were exposed per gavage the read-across substance Similar Substance 01 at 2150 and 5000 mg/kg bw. The animals were observed for clinical signs and mortality during a 14-day post-exposure observation period. No mortality occured. Under the conditions of the test the LD50 in male and female rats after oral application was > 5000 mg/kg bw.
SUPPORTING: Acute oral toxicity (BASF, 1975)
In an acute oral toxicity study (equivalent or simlar to the method described in OECD guideline 401) five male and 5 female Sprague-Dawley rats were exposed via to the read-across substance Similar Substance 02 at 3200, 6400 or 10000 mg/kg bw. The animals were observed for clinical signs and mortality during a 14-day post-exposure observation period. No mortality occured in the 3200 mg/kg bw dose group. At 6400 and 10000 mg/kg bw 4 of 10 and 5 of 10 animals died, respectively. Clinical signs comprised dyspnoea, violet discolored skin and faeces, partially diarrhoea, apathy, and slight atonia. During necropsy, acute cardiac dilation with congestive hyperemia, diarrheal intestinal contents, stomach dilation, and slightly stained organs were observed in animlas that died. Under the conditions of this study the LD50 in male and female rats after oral application was determined to be ca. 10000 mg/kg bw.
VIA INHALATION ROUTE:
WOE: Acute inhalation toxicity (BASF, 1980)
Six male and six female Sprague-Dawley rats were exposed for seven hours to the read-across substance Similar Substance 01 at a calculated saturated concentrations of 6.51 mg/L air. All animals were observed for clinical signs and mortality during the inhalation exposure. Body weights were recorded prior to exposure on test day 1. After 7h all surviving animals were sacrificed and necropsied.
No mortality and no clinical signs of toxicity after exposure to the test item were detected. No abnormalities in macroscopic pathological findings.
Thus, the LC0, inhalation (aerosol), rat was determined to be > 6.51 mg/L air.
WOE: Acute inhalation toxicity (BASF, 1975)
Six male and six female rats (strain not specified) were exposed for eight hours to the read-across substance Similar Substance 02 at a calculated saturated concentrations of 7.53 mg/L air. All animals were observed for clinical signs and mortality during the inhalation exposure. Body weights were recorded prior to exposure on test day 1. After 8h all surviving animals were sacrificed and necropsied.
No mortality and no clinical signs of toxicity after exposure to the test item were detected. No abnormalities in macroscopic pathological findings.
Thus, the LC0, inhalation (aerosol), rat was determined to be > 7.53 mg/L air.
VIA DERMAL ROUTE:
KEY: Acute dermal toxicity (BASF, 1975)
In an acute dermal toxicity study 5 male and 5 female young adult Sprague-Dawley rats were dermally exposed to a single dose of 2500 mg/kg bw of the read-across substance Similar Substance 02 (as suspension in water) to the clipped skin (dorsal) for 24 hours. The application area was 50 cm². The animals were observed for 14 days. The following test substance-related clinical observations were recorded:
No mortality and no clinical signs of toxicity after exposure to the test item were detected. No abnormalities in macroscopic pathological findings. Purple remains of the test substance were observed throughout the study period.
Thus, the LD0, dermal, rat was determined to be > 2500 mg/kg bw.
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 (EC) No 1272/2008.
The acute oral LD50 was determined to be greater than 2000 mg/kg bw. As a result the substance is not classified and labelled as acute toxic under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
The acute inhalation LC50 was determined to be greater than 6.51 mg/L after 8h exposure in saturated air. As no higher concentrations can be measured due to saturation, the substance is not classified and labelled as acute toxic under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
The acute dermal LD50 was determined to be greater than 2500 mg/kg bw. As a result the substance is not classified and labelled as acute toxic under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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