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EC number: 916-226-6 | CAS number: -
- 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
A valid oral toxicity study according to OECD guideline 401 with Katalysator WAZ 5596 B is on hand. For acute inhalation toxicity a study according OECD TG 403 was conducted. In this study groups of rats were exposed nose-only to an aerosol of Katalysator WAZ 5596-B. No studys for acute dermal toxicity is available.
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:
- other: scientifically acceptable and well documented
- Principles of method if other than guideline:
- Four groups of 5 male and 5 groups of 5 female Wister rats (average weight 171-177 g) each received per gavage a single dose of 500 to 2300 mg/kg bw Katalysator WAZ 5596 B. The animals were observed for mortality, weight and clinical signs through day 14.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- male rats: 500, 1000, 2000, 2300 mg/kg bw
female rats: 500, 1000, 1300, 1600, 2000 mg/kg bw - No. of animals per sex per dose:
- 5 male and 5 female rats/dose
- Control animals:
- no
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 457 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- harmful
- Remarks:
- Migrated information
- Executive summary:
Four or five groups of 5 male and female Wister rats (average weight 171-177 g) each received per gavage a single dose of 500 to 2300 mg/kg bw Katalysator WAZ 5596 B. The animals were observed for mortality, weight and clinical signs through day 14.
As signs of intoxication reduction of general condition, sedation and rough fur, gasping and staggered gait were observed in the dose range of 1000 to 2300 mg/kg bw. body weight gain was retared in the first post-observation period.
A single dose of 500 mg/kg bw Katalysator WAZ 5596 B was tolerated by male and female rats without symptoms; LD50 = 1457 mg/kg bw.
Reference
The corresponding mortality for male rats was 0% (500 mg/kg bw), 20% (1000 mg/kg bw), 40% (2000 ml/kg bw), 100% (2300 mg/kg bw), respectively.
The corresponding mortality for female rats was 0% (500 mg/kg bw), 0% (1000 mg/kg bw), 60% (1300 ml/kg bw), 60% (1600 mg/kg bw) and 100% (2000 ml/kg bw) respectively.
A single dose of 1000 to 2300 mg/kg bw Katalysator WAZ 5596 B caused on male and female rats the following signs of intoxication: reduction of general condition, sedation and rough fur. Surroundings of the eye was bloody in 1 male animals dosed with 2000 mg/kg bw and a bloody snout was visible on 2 female animale dosed with 1300 mg/kg bw. Gasping was observed 1 male and 1 female rats dosed with 1000 mg/kg bw. A swelled belly was observed in 1 male rat dosed with 1000 mg/kg bw and a increased diuresis on female animals dosed with 1600 mg/kg bw.A staggered gait was evident on females doses with 1300 or 1300 mg/kg bw.
Additional, with doses of 1000 to 2000 mg/kg bw (males) and 1000 to 1600 mg/kg bw (females) a weight reduction was observed.
Symptoms were evident 2 hour after application and continued until day 11 of the examination period.
Necropsy on animals dosed with 1000 to 2300 mg/kg bw, which died during post-observation period:
stomach mucosa was damaged, stomach and intestines were inflated, partly stomach was adhered with liver, spleen and diaphragm.
Animals dosed with 2300 mg/kg bw showed a strong reddened lung and in the chest cavity a clear reddish fluid was found
Necropsy of animals killed of post-observation period:
animals dosed wth 500 to 1000 mg/kg bw showed were without pathological findings
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 1 457 mg/kg bw
- Quality of whole database:
- The materials/methods and results are described in detail und are sufficient for evaluation
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP conform guidelinestudy
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- Four groups of rats were nose-only exposed to actual concentrations of 71.8, 168.5, 280.4, and 394.4 mg/m³. The aerosol was generated neat without any vehicle. The animals were observed for mortality, weight and clinical signs through day 14. A gross necropsy was performed.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- other: Wistar, strain HsdRCCHan
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Group 1 Group 2 Group 3 Group 4 Group 5
Target Conc. (mg/m³) 0 75 200 340 500
Nominal Conc. (mg/m³) (Control Air) 158.3 455.6 519.4 838.9
Gravimetric Conc. (mg/m³) -- 71.8 168.5 280.4 394.4 - No. of animals per sex per dose:
- Three male and three female rats were simultaneously exposed to the starting concentration under nose-only conditions for 4 h (start of study with group 5). All other concentrations utilize five animals/sex/group. This procedure is in compliance with OECD GD#39 (2009).
- Control animals:
- other: historical control
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 280 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Executive summary:
A study on the acute inhalation toxicity of KATALYSATOR WAZ 5596-B (henceforward referred to as test substance) on rats has been conducted in accordance with OECD TG#403 (2009). Test procedures were adapted so as to comply also with the EU Directive 92/69/EEC, and especially OECD GD#39 (2009). Four groups of rats were nose-only exposed to actual concentrations of 71.8, 168.5, 280.4, and 394.4 mg/m³. The aerosol was generated neat without any vehicle. The results can be summarized as follows:
LC50 inhalation (liquid aerosol, 4 h): LC50-males&females: 280 mg/m³)
NO(A)EL: Males&females: <71.8 mg/m³air)
Mortality occurred at 280.4 and 394.4 mg/m³ and most rats succumbed within one day postexposure. The following clinical signs were observed: bradypnea, dyspnea, labored breathing patterns, breathing sounds, irregular breathing patterns, motility reduced,atony, high-legged gait, hair-coat ungroomed, piloerection, cyanosis, emaciation, nasal discharge (serous), nose: red encrustations, muzzle: red discoloration, prostration, tremor, gait squatted, urine: reddish discoloration, eyes: red encrustations, abdomen enlarged, bloated abdomen, salivation, decreased reflexes, hypothermia, and transient decrease in body weights. Gross necropsy demonstrated frank acute lung edema which is taken as cause of death. The lead pathodiagnostic effects were related to respiratory tract irritation which was not reversible within the 2-week exposure period.
The respirability of the aerosol was adequate to achieve the objective of study, i.e. the average mass median aerodynamic diameter (MMAD) was ~ 1.4 μm, the average geometric standard deviation (GSD) was ~2.3.
In summary, the aerosolized test substance proved to have a high acute inhalation toxicity in rats. Mortality was caused by lung irritation and subsequent lung edema formation.
Reference
Mortality occurred at 280.4 and 394.4 mg/m³ and most rats succumbed within one day postexposure. The following clinical signs were observed: bradypnea, dyspnea, labored breathing patterns, breathing sounds, irregular breathing patterns, motility reduced, atony, high-legged gait, hair-coat ungroomed, piloerection, cyanosis, emaciation, nasal discharge (serous), nose: red encrustations, muzzle: red discoloration, prostration, tremor, gait squatted, urine: reddish discoloration, eyes: red encrustations, abdomen enlarged, bloated abdomen, salivation, decreased reflexes, hypothermia, and transient decrease in body weights. Gross necropsy demonstrated frank acute lung edema which is taken as cause of death. The lead pathodiagnostic effects were related to respiratory tract irritation which was not reversible within the 2-week exposure period.
Endpoint conclusion
- Dose descriptor:
- LC50
- Value:
- 280 mg/m³ air
- Quality of whole database:
- The materials/methods and results are described in detail und are sufficient for evaluation
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a valid oral toxicity study a LD50 = 1457 mg/kg bw for male and female rats was found. A single dose of 500 mg/kg bw Katalysator WAZ 5596 B was tolerated by male and female rats without symptoms.
In a valid acute inhalation toxicity study a LC50 = 280 mg/m³ was determined. Mortality was caused by lung irritation and subsequent lung edema formation. The NOAEL was < 71 mg/m³ air.
Justification for selection of acute toxicity – oral endpoint
only available study
Justification for selection of acute toxicity – inhalation endpoint
only available study
Justification for classification or non-classification
Due to the results of the acute oral toxicity study and the acute inhalation toxicity study a classification with R 22 (harmful if swallowed) and R 23 (toxic by inhalation); GHS: Acute Tox. 4 (H302: Harmful if swallowed) and Acute tox. 2 (H330: Fatal if inhaled) is justified.
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