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EC number: 278-248-6 | CAS number: 75535-16-9
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Target and source differ only in the salt form
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source: Mixture of Basic Violet 16 Oxalate / EC 281-588-8 / CAS 83969-11-3 and Basic Violet 16 Sulfate / EC 281-474-8 / CAS 83950-22-5
Target: Basic Violet 16 Dihydrogenphosphate / EC 278-248-6 / CAS 75535-16-9
3. ANALOGUE APPROACH JUSTIFICATION
see attached justification document in section 13
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 2 to 3 months
- Weight at study initiation: 160 g to 200 g
- Fasting period before study: -
- Housing: groups of 5
- Bedding: wood glanulate type S 8/15 Ssniff, Germany
- Diet (ad libitum): ltrominc)1324 - Haltungsdiat fur Ratten und Mause, Altromin GmbH, Lage, Germany
- Water (ad libitum): tap
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): ca. 50
- Air changes (per hr): ca. 10-fold
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 8. Sep to 28. Oct 1988 - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 4 µm
- Geometric standard deviation (GSD):
- 1.94
- Remark on MMAD/GSD:
- 8.0 mg/m³ air: MMAD: 3.98 µm; GSD: 1.94
53 mg/m³ air: MMAD: 3.04 µm; GSD: 2.21
240 mg/m³ air: MMAD: 5.58 µm; GSD: 1.54
2386 mg/m³ air: MMAD: 32.1 µm; GSD: 2.11 - Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: exposure tubes were adapted to the growth of the rats (Fa Rhema Labortechnik, Hofheim, Germany) - Head/Nose exposition
- Exposure chamber volume: ca. 20 liter
- Source and rate of air: 2 parallel connected Boge compressors (SB 270/15/350D) - ca. 800 to 1000 kPa air pressure; 84-times air change rate/h, monitored by a calibrated Rotameter
- Method of conditioning air: conditioned by a downstream "VIA-Drucklufttrockner" (Typ A 110)
- System of generating particulates/aerosols: High concentrations: "Bayer-Staubgeneratoren"; low concentrations: "Wright-Dust-Feeder"; nebulized in cylindric inhalation chamber under dynamic conditions
- Method of particle size determination: gravimetric with Andersen cascade impactor
- Treatment of exhaust air: 70% of the fed air is exhaust air, purified by a cotton filter
- Temperature & humidity in air chamber (Leybold-Heraeus Meßsystem):
- without rats
- temperature: 24°C
- rel. humidity: 14%
- with rats
- temperature: 25°C
- rel. humidity: 34%
- during recent study
- temperature: 20 - 24°C
- rel. humidity: < 10%
- Pressure in air chamber:
- max. dispersion pressure: ca. 200 kPa
- supply air: ca. 28 L/min
- exhaust air: ca. 20 L/min
TEST ATMOSPHERE
- Brief description of analytical method used: filter analysis, gravimetrical determination
- Samples taken from breathing zone: yes
VEHICLE
- Composition of vehicle (if applicable): no vehicle other than air used
- Concentration of test material in vehicle (if applicable): 8, 53, 240, 2386 mg/m³ air
TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):
8.0 mg/m³ air: MMAD: 3.98 µm; GSD: 1.94
53 mg/m³ air: MMAD: 3.04 µm; GSD: 2.21
240 mg/m³ air: MMAD: 5.58 µm; GSD: 1.54
2386 mg/m³ air: MMAD: 32.1 µm; GSD: 2.11 - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- target concentration: 8.0 mg/m³ air (all concentrations are given in mg dye/m³ air)
computed concentration: 13.1 mg/m³ air
MMAD: 3.98 µm; GSD: 1.94; NMAD: 1.06 µm; SMAD: 2.56 µm
respirability (% <= 5 µm): mass related: 64% (measured)
number related: 99% (extrapolated)
target concentration: 53 mg/m³ air
computed concentration: 47.5 mg/m³ air
MMAD: 3.04 µm; GSD: 2.21; NMAD: 0.458 µm; SMAD: 1.62 µm
respirability (% <= 5 µm): mass related: 74% (measured)
number related: 100% (extrapolated)
target concentration: 240 mg/m³ air
computed concentration: 209.2 mg/m³ air
MMAD: 5.58 µm; GSD: 1.54; NMAD: 3.15 µm; SMAD: 4.61 µm
respirability (% <= 5 µm): mass related: 41% (measured)
number related: 86% (extrapolated)
target concentration: 2386 mg/m³ air
computed concentration: 6240.6 mg/m³ air
MMAD: 32.1 µm; GSD: 2.11; NMAD: 5.97 µm; SMAD: 18.3 µm
respirability (% <= 5 µm): mass related: 1% (measured)
number related: 41% (extrapolated) - No. of animals per sex per dose:
- 5
10 controls - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- clinical signs: Day 1: multiple times
Days 2 to 14: twice daily
- body weight: pre-treatment, Day 3, Day 7, weekly thereafter
- Necropsy of survivors performed: yes
- other: Irwin screen, rectal temperature - Statistics:
- means , standard deviations, statistical significance (p<=0.05 and 0.01)
Necropsy: Respiratory tract findings: RxC Chi-Square test, pairwise Fisher's test
Body weight: means , standard deviations; analysis of variances; Box-test for homogeneity; Games and Howell modification of Tukey-Kramer tesst
Particle analysis: MMAD, GSD (probit-transformed mass-related cumulative frequency distribution, logarithmized effective cut-off diameter
Concentration analytics: means, standard deviations
LC50: Maximum-Likelihood method - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 53 mg/L air (analytical)
- Based on:
- act. ingr.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 0.053 mg/L air (analytical)
- Based on:
- act. ingr.
- Exp. duration:
- 4 h
- Mortality:
- Conc. [mg/m³] deaths (M/F)
8 0/0
53 2/4
240 5/5
2386 5/5 - Clinical signs:
- other: dose dependent clinical signs all dose-groups: hypoactivity, piloerection, unkempt appearance, labored respiration, bradypnoea in addition at 53 mg/m³: agonal tonic convultions - males 240 mg/m³: agonal ataxia - all agonal: apnoea, pro
- Body weight:
- transient decrease in surviving animals
- Gross pathology:
- intermittent deaths: hepatization of lung; lung edema, hydrothorax; pale liver with accentuated lobular pattern; pale mottled kidneys with reddened pelvic area; dark spleen; reddened glandular stomach with ulcerous foci; small intestines reddened, reddish content; gastro-intestinal tract with yellow mucoid content; test-item related discolouration of inner organs.
terminal sacrifices: no effects - Interpretation of results:
- Category 2 based on GHS criteria
- Conclusions:
- Basic Violet 16 showed inhalation toxicity in the rat. This effect was mainly triggered by strong irritatng effects to the lung. There were signs of a concentration-dependent severe irritation of the respiratory tract as well as unspecific clinical signs and a transient decrease in body weight in all surviving animals.
The approximative LC50 for rats is 53 mg/m³ air
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium dihydrogen phosphate
- EC Number:
- 278-248-6
- EC Name:
- 2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium dihydrogen phosphate
- Cas Number:
- 75535-16-9
- Molecular formula:
- C23H29N2.H2O4P
- IUPAC Name:
- 2-[2-[4-(diethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium dihydrogen phosphate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 2 to 3 months
- Weight at study initiation: 160 g to 200 g
- Fasting period before study: -
- Housing: groups of 5
- Bedding: wood glanulate type S 8/15 Ssniff, Germany
- Diet (ad libitum): ltrominc)1324 - Haltungsdiat fur Ratten und Mause, Altromin GmbH, Lage, Germany
- Water (ad libitum): tap
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): ca. 50
- Air changes (per hr): ca. 10-fold
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 8. Sep to 28. Oct 1988
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 4 µm
- Geometric standard deviation (GSD):
- 1.94
- Remark on MMAD/GSD:
- 8.0 mg/m³ air: MMAD: 3.98 µm; GSD: 1.94
53 mg/m³ air: MMAD: 3.04 µm; GSD: 2.21
240 mg/m³ air: MMAD: 5.58 µm; GSD: 1.54
2386 mg/m³ air: MMAD: 32.1 µm; GSD: 2.11 - Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: exposure tubes were adapted to the growth of the rats (Fa Rhema Labortechnik, Hofheim, Germany) - Head/Nose exposition
- Exposure chamber volume: ca. 20 liter
- Source and rate of air: 2 parallel connected Boge compressors (SB 270/15/350D) - ca. 800 to 1000 kPa air pressure; 84-times air change rate/h, monitored by a calibrated Rotameter
- Method of conditioning air: conditioned by a downstream "VIA-Drucklufttrockner" (Typ A 110)
- System of generating particulates/aerosols: High concentrations: "Bayer-Staubgeneratoren"; low concentrations: "Wright-Dust-Feeder"; nebulized in cylindric inhalation chamber under dynamic conditions
- Method of particle size determination: gravimetric with Andersen cascade impactor
- Treatment of exhaust air: 70% of the fed air is exhaust air, purified by a cotton filter
- Temperature & humidity in air chamber (Leybold-Heraeus Meßsystem):
- without rats
- temperature: 24°C
- rel. humidity: 14%
- with rats
- temperature: 25°C
- rel. humidity: 34%
- during recent study
- temperature: 20 - 24°C
- rel. humidity: < 10%
- Pressure in air chamber:
- max. dispersion pressure: ca. 200 kPa
- supply air: ca. 28 L/min
- exhaust air: ca. 20 L/min
TEST ATMOSPHERE
- Brief description of analytical method used: filter analysis, gravimetrical determination
- Samples taken from breathing zone: yes
VEHICLE
- Composition of vehicle (if applicable): no vehicle other than air used
- Concentration of test material in vehicle (if applicable): 8, 53, 240, 2386 mg/m³ air
TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):
8.0 mg/m³ air: MMAD: 3.98 µm; GSD: 1.94
53 mg/m³ air: MMAD: 3.04 µm; GSD: 2.21
240 mg/m³ air: MMAD: 5.58 µm; GSD: 1.54
2386 mg/m³ air: MMAD: 32.1 µm; GSD: 2.11 - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- target concentration: 8.0 mg/m³ air (all concentrations are given in mg dye/m³ air)
computed concentration: 13.1 mg/m³ air
MMAD: 3.98 µm; GSD: 1.94; NMAD: 1.06 µm; SMAD: 2.56 µm
respirability (% <= 5 µm): mass related: 64% (measured)
number related: 99% (extrapolated)
target concentration: 53 mg/m³ air
computed concentration: 47.5 mg/m³ air
MMAD: 3.04 µm; GSD: 2.21; NMAD: 0.458 µm; SMAD: 1.62 µm
respirability (% <= 5 µm): mass related: 74% (measured)
number related: 100% (extrapolated)
target concentration: 240 mg/m³ air
computed concentration: 209.2 mg/m³ air
MMAD: 5.58 µm; GSD: 1.54; NMAD: 3.15 µm; SMAD: 4.61 µm
respirability (% <= 5 µm): mass related: 41% (measured)
number related: 86% (extrapolated)
target concentration: 2386 mg/m³ air
computed concentration: 6240.6 mg/m³ air
MMAD: 32.1 µm; GSD: 2.11; NMAD: 5.97 µm; SMAD: 18.3 µm
respirability (% <= 5 µm): mass related: 1% (measured)
number related: 41% (extrapolated) - No. of animals per sex per dose:
- 5
10 controls - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- clinical signs: Day 1: multiple times
Days 2 to 14: twice daily
- body weight: pre-treatment, Day 3, Day 7, weekly thereafter
- Necropsy of survivors performed: yes
- other: Irwin screen, rectal temperature - Statistics:
- means , standard deviations, statistical significance (p<=0.05 and 0.01)
Necropsy: Respiratory tract findings: RxC Chi-Square test, pairwise Fisher's test
Body weight: means , standard deviations; analysis of variances; Box-test for homogeneity; Games and Howell modification of Tukey-Kramer tesst
Particle analysis: MMAD, GSD (probit-transformed mass-related cumulative frequency distribution, logarithmized effective cut-off diameter
Concentration analytics: means, standard deviations
LC50: Maximum-Likelihood method
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 53 mg/L air (analytical)
- Based on:
- act. ingr.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 0.053 mg/L air (analytical)
- Based on:
- act. ingr.
- Exp. duration:
- 4 h
- Mortality:
- Conc. [mg/m³] deaths (M/F)
8 0/0
53 2/4
240 5/5
2386 5/5 - Clinical signs:
- other: dose dependent clinical signs all dose-groups: hypoactivity, piloerection, unkempt appearance, labored respiration, bradypnoea in addition at 53 mg/m³: agonal tonic convultions - males 240 mg/m³: agonal ataxia - all agonal: apnoea, pro
- Body weight:
- transient decrease in surviving animals
- Gross pathology:
- intermittent deaths: hepatization of lung; lung edema, hydrothorax; pale liver with accentuated lobular pattern; pale mottled kidneys with reddened pelvic area; dark spleen; reddened glandular stomach with ulcerous foci; small intestines reddened, reddish content; gastro-intestinal tract with yellow mucoid content; test-item related discolouration of inner organs.
terminal sacrifices: no effects
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 based on GHS criteria
- Conclusions:
- Basic Violet 16 showed inhalation toxicity in the rat. This effect was mainly triggered by strong irritatng effects to the lung. There were signs of a concentration-dependent severe irritation of the respiratory tract as well as unspecific clinical signs and a transient decrease in body weight in all surviving animals.
The approximative LC50 for rats is 53 mg/m³ air
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