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EC number: 256-050-0 | CAS number: 43035-18-3
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 November 2022 to 01 December 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Title:
- Unnamed
- Year:
- 2 023
- Report date:
- 2023
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- OECD Guidelines for Testing of Chemicals No. 403 – Traditional Protocol “Acute Inhalation Toxicity” adopted on 07 September 2009
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- traditional method
- Limit test:
- yes
Test material
- Reference substance name:
- Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]
- EC Number:
- 256-050-0
- EC Name:
- Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]
- Cas Number:
- 43035-18-3
- Molecular formula:
- C32H26N4O7S.1/2Ca
- IUPAC Name:
- calcium bis(4-{[3-({2-hydroxy-3-[(4-methoxyphenyl)carbamoyl]-1-naphthyl}diazenyl)-4-methylbenzoyl]amino}benzenesulfonate)
- Test material form:
- solid: nanoform, no surface treatment
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house bred
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 weeks
- Weight at study initiation: Males: 182.12 g to 191.26 g; Females: 166.18 g to 179.49 g
- Housing: Three animals per sex were housed in a standard polycarbonate cage (size: L 430 × B 280 × H 210 mm) with stainless steel mesh top grill having facilities for holding pelleted feed and drinking water in water bottle fitted with stainless steel sipper tube
- Diet (e.g. ad libitum): yes and Altromin maintenance diet for rats and mice (manufactured by Altromin Spezialfutter GmbH & Co. KG)
- Water (e.g. ad libitum): yes and Deep bore-well water passed through reverse osmosis unit
- Acclimation period: 11 November 2022 to 16 November 2022
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9°C to 22.6°C
- Humidity (%): 43% to 66%
- Air changes (per hr): 12 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours fluorescent light and 12 hours dark cycle
IN-LIFE DATES: From: 11 November 2022 To: 01 December 2022
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- clean air
- Mass median aerodynamic diameter (MMAD):
- > 2.98 - <= 3.23 µm
- Geometric standard deviation (GSD):
- > 2.71 - <= 2.77
- Remark on MMAD/GSD:
- within the specified range as per guideline
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: nose-only dynamic inhalation exposure system
- Exposure chamber volume: 0.76
- Method of holding animals in test chamber: Restrainers
- Source and rate of air (airflow): 20 lt per minute
- Method of conditioning air: filtered air
- System of generating particulates/aerosols: Rotating Brush Generator (Palas RBG 1000 - supplied by Palas GmbH)
- Method of particle size determination: Gravimetric method
- Treatment of exhaust air: NaOH
- Temperature, humidity, pressure in air chamber: 22.3°C to 22.8°C, 52.9% to 56.5%, 60 psi
TEST ATMOSPHERE
- Samples taken from breathing zone: yes
- Time needed for equilibrium of exposure concentration before animal exposure:
t95 (min) = 3× Chamber Volume / Chamber airflow
= 3× 0.76 L / 20 L/min
= 0.11 minutes
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: As per guidelines the limit concentration was 5 mg/L of air. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- > 0 - <= 240 min
- No. of animals per sex per dose:
- Limit Test - 3 Males and 3 Females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: once daily for clinical signs and twice daily for mortality and weighing of animals on day 1, 3, 7 and 14
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.04 mg/L air
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: No treatment related clinical signs and mortality were observed at the mean limit concentration of 5.04 mg/L of air. Post exposure observation, i.e., on day 2 and day 3 test item color feces was noted
- Body weight:
- No treatment related changes were observed in body weight and percent change in body weight with respect to day 1 at the mean limit concentration of 5.04 mg/L of air. However, all animals showed slight decrease in body weight on day 2 due to exposure and increased in body weight from day 4 onwards
- Gross pathology:
- No treatment related gross pathological findings were observed at the mean limit concentration of 5.04 mg/L of air
Any other information on results incl. tables
Group & Concentration (mg/L of air) | Animal No. | Sex | Day 1 | Days | ||||||||||||||||||
During Exposure | Post exposure | |||||||||||||||||||||
1 hr* | 2 hrs* | 3 hrs* | 4 hrs* | 30-40 min | 1 hr* | 2# | 3# | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | |||
Limit Test & 5.04 | Rh7081 | M | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
Rh7082 | M | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rh7083 | M | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rh7084 | F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rh7085 | F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | |
Rh7086 | F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N | N |
*: ± 10 minutes; N: Normal; M: Male; F: Female; min: minute; hr(s): hour(s); #Test item color feces noted
Group & Concentration (mg/L of air) | Animal No. | Sex | Body Weight (g) on Days |
| Percent Change in Body Weight with Respect to Day 1 | |||||||
1# | 2 | 4 | 8 | 15 |
| 1-2 | 1-4 | 1-8 | 1-15 | |||
Limit Test & 5.04 | Rh7081 | M | 203.36 | 200.65 | 204.77 | 217.17 | 239.19 |
| -1.33 | 0.69 | 6.79 | 17.62 |
Rh7082 | M | 211.19 | 209.39 | 213.39 | 228.24 | 252.32 |
| -0.85 | 1.04 | 8.07 | 19.48 | |
Rh7083 | M | 208.93 | 205.49 | 209.42 | 223.46 | 246.25 |
| -1.65 | 0.23 | 6.95 | 17.86 | |
Mean |
| 207.83 | 205.18 | 209.19 | 222.96 | 245.92 |
| -1.28 | 0.66 | 7.27 | 18.32 | |
(±) SD |
| 4.03 | 4.38 | 4.31 | 5.55 | 6.57 |
| 0.40 | 0.40 | 0.70 | 1.01 | |
n |
| 3 | 3 | 3 | 3 | 3 |
| 3 | 3 | 3 | 3 | |
Rh7084 | F | 182.41 | 180.82 | 183.58 | 192.61 | 211.67 |
| -0.87 | 0.64 | 5.59 | 16.04 | |
Rh7085 | F | 187.05 | 186.66 | 188.15 | 199.82 | 214.70 |
| -0.21 | 0.59 | 6.83 | 14.78 | |
Rh7086 | F | 195.88 | 193.71 | 196.21 | 206.09 | 223.52 |
| -1.11 | 0.17 | 5.21 | 14.11 | |
Mean |
| 188.45 | 187.06 | 189.31 | 199.51 | 216.63 |
| -0.73 | 0.47 | 5.88 | 14.98 | |
(±) SD |
| 6.84 | 6.45 | 6.39 | 6.75 | 6.16 |
| 0.47 | 0.26 | 0.84 | 0.98 | |
n |
| 3 | 3 | 3 | 3 | 3 |
| 3 | 3 | 3 | 3 |
#: Prior to exposure; M: Male; F: Female; SD: Standard Deviation; n; Number of animals
Technical Pre-test:
Sl. No. | Feed rate (mm/hour) | Rotation (rpm) | Initial weight (mg) (a) | Final weight (mg) (b) | Difference (mg) (c) = (b) – (a) | Air Flow Rate (L/min) (d) | Time (min) (e) | BZC (mg/L of air) |
Mean BZC (mg/L of Air) |
1 | 30 | 600 | 345.71 | 353.34 | 7.63 | 1.52 | 1 | 5.02 | 5.03 |
2 | 30 | 600 | 350.65 | 358.31 | 7.66 | 1.52 | 1 | 5.04 |
Limit Test:
Sl. No. | Feed rate (mm/hour) | Rotation (rpm) | Initial weight (mg) (a) | Final weight (mg) (b) | Difference (mg) (c) = (b) – (a) | Air Flow Rate (L/min) (d) | Time (min) (e) | BZC (mg/L of air) | Mean BZC (mg/L of Air) |
1 | 30 | 600 | 350.05 | 357.69 | 7.64 | 1.52 | 1 | 5.03 | 5.04 |
2 | 30 | 600 | 356.09 | 363.78 | 7.69 | 1.52 | 1 | 5.06 | |
3 | 30 | 600 | 349.86 | 357.53 | 7.67 | 1.52 | 1 | 5.05 |
BZC: Breathing Zone Concentration; Sampled volume: 1.52 L/min; Sampling time: 1 minute
Mass of test item collected on the filter paper (c) | |
Volume of air passed through the filter paper (d) X time (e) |
Technical Pre-test:
Concentration (mg/L of air) | SL. No. | Feed rate (mm/hour) | Rotation (rpm) | Temperature (°C) | Relative Humidity (%) | Oxygen Concentration (%) | Carbon dioxide Concentration (ppm) | Air Flow (L/min) |
5.03 | 1 | 30 | 600 | 22.4 | 54.6 | 20.5 | 616 | 20 |
2 | 30 | 600 | 22.3 | 53.5 | 20.6 | 625 | 20 |
Limit Test:
Concentration (mg/L of air) | SL. No. | Feed rate (mm/hour) | Rotation (rpm) | Temperature (°C) | Relative Humidity (%) | Oxygen Concentration (%) | Carbon dioxide Concentration (ppm) | Air Flow (L/min) |
5.04 | 1 | 30 | 600 | 22.8 | 52.9 | 20.3 | 613 | 20 |
2 | 30 | 600 | 22.4 | 54.5 | 20.6 | 621 | 20 | |
3 | 30 | 600 | 22.5 | 56.5 | 20.3 | 619 | 20 | |
4 | 30 | 600 | 22.3 | 55.8 | 20.4 | 615 | 20 |
Note: 1% Carbon dioxide = 10000 ppm
Technical Pre-Test | |
Chamber Conditions | Range |
Feed Rate (mm/hour) and Speed (RPM) | 30 and 600 |
Temperature (°C) | 22.3 to 22.4 |
Relative humidity (%) | 53.5 to 54.6 |
Oxygen concentration (%) | 20.5 to 20.6 |
Carbon dioxide concentration (ppm) | 616 to 625 |
Air Flow (L/min)* | 20 |
BZC (mg/L) | 5.02 to 5.04 |
MMAD (µm) | 3.06 # |
GSD | 2.71 # |
Limit Test | |
Feed Rate (mm/hour) and Speed (RPM) | 30 and 600 |
Temperature (°C) | 22.3 to 22.8 |
Relative humidity (%) | 52.9 to 56.5 |
Oxygen concentration (%) | 20.3 to 20.6 |
Carbon dioxide concentration (ppm) | 613 to 621 |
Air Flow (L/min)* | 20 |
BZC (mg/L) | 5.03 to 5.06 |
MMAD (µm) | 2.98 to 3.23 |
GSD | 2.71 to 2.77 |
*: Values were constant throughout the exposure; #: Individual value; BZC: Breathing Zone Concentration (Actual Concentration), MMAD: Mass Median Aerodynamic Diameter, GSD: Geometric Standard Deviations.
Group & Concentration (mg/L of air) | Animal No. | Sex | Fate | Gross Pathology Findings | |
External | Internal | ||||
Limit Test & 5.04 | Rh7081 | M | TS | NAD | NAD |
Rh7082 | M | TS | NAD | NAD | |
Rh7083 | M | TS | NAD | NAD | |
Rh7084 | F | TS | NAD | NAD | |
Rh7085 | F | TS | NAD | NAD | |
Rh7086 | F | TS | NAD | NAD |
NAD: No Abnormality Detected; M: Male; F: Female; TS: Terminal Sacrifice
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Based on the results of this study the test item has not to be classified for acute inhalation toxicity according to Regulation (EC) No 1272/2008.
- Conclusions:
- Under the experimental conditions employed and based on the above results of experiment, there were no clinical signs and mortality observed at the mean limit concentration of 5.04 mg/L of air. Hence, the LC50 of the test item is > 5.04 mg/L of air.
- Executive summary:
The test item was evaluated for acute inhalation toxicity in Sprague Dawley rats.
The objective of the study was to assess the toxic potential and to determine the LC50 of test item when administered by inhalation route through flow-past nose-only dynamic inhalation equipment for a single 4 hours exposure to rats. Three male and three female rats were used for conducting the acute inhalation toxicity study.
As such test item was used during technical pre-test and limit test to generate the dust aerosols through rotating brush generator. The technical pre-test was carried out without animals. During the technical pre-test, the target concentration i.e. 5.04 mg/L of air was achieved at the feed rate of 30 mm/hour with a rotation of 600 RPM.
During the exposure period, the temperature, relative humidity, oxygen and carbon dioxide concentration of the chamber was found within the acceptable limits. The particle size MMAD and GSD values were within the acceptable limits, at the mean limit concentration of 5.04 mg/L of air.
All animals were observed for clinical signs of toxicity and mortality during exposure and post exposure on day 1 and once daily thereafter for clinical signs and twice daily for mortality for 14 days for post exposure period. Individual animal body weight was recorded on day 1 (on the day of exposure) prior to the exposure and on day 2, 4, 8 and 15. All the rats were euthanized after 14 days post exposure by intraperitoneal administration of sodium thiopentone and they were subjected to gross necropsy.
No treatment related clinical signs of toxicity and mortalities were observed. Slight decrease in body weight was noted on Day 2 due to exposure. All animals showed increase in body weight on day 4, 8 and 15.
No treatment related gross pathological findings were observed at the mean limit concentration of 5.04 mg/L of air.
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