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EC number: 942-925-0 | 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
The acute oral, inhalation and dermal toxicity was examined in rats by using the respective guidelines under GLP conditions .
LD50 (oral, dermal) > 2000 mg/kg bw; LD50 (inhalation) > 2590 mg/m³.
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guidelinestudy under GLP condition
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation: 8 weeks
- Weight at study initiation:´176.9 g - 205.0 g
- Fasting period before study:
- Housing: 3 animals per cage
- Diet ad libitum, fasting of 20 hours prior to administration
- Water ad libitum
- Acclimation period: 5days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- other: water for injection
- Details on oral exposure:
- The test substance was formulated with water for injection and givel only once by oral gavage. Starting dose level was selected 300 mg/kg bw as recommended by the respective guideline. The dose level was 300 mg/kg bw (1st, 2nd step), 2000 mg/kg bw (3rd, 4th step) and 3 animals were used for each step. these steps showed no mortality in the dosed amimals
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 animals per step , 4 steps
- Control animals:
- no
- Details on study design:
- The test substance was formulated with water for injection and given only once by oral gavage. Starting dose level was selected 300 mg/kg bw as recommended by the respective guideline. The dose level was 300 mg/kg bw (1st, 2nd step), 2000 mg/kg bw (3rd, 4th step) and 3 animals were used for each step. These steps showed no mortality in the dosed amimals. Clinical signs were observed for 4 hours after treatment and then once every day for 14 days . Body weight was measured on animal recept day , animal allocation day , just before treatment and on day 7 and day 14 after treatment. On the end of study period all animlas were sacrificed and autopsy was conducted to all animals and the organs were examined for gross lesions
- Statistics:
- no data
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no clinical signs, no mortality, body weight gain, no gross pathological findings at necropsy
- Mortality:
- no animal died
- Clinical signs:
- no clinical signs were observed
- Body weight:
- animals gained body weight
- Gross pathology:
- no findings
- Executive summary:
The acute oral toxicity was tested in female rats using the acute toxic class method according to OECD TG 423 under GLP conditions. Azo zinc complex Pigment - Melamine compound was formulated with water for injection and given only once by oral gavage. Starting dose level was selected 300 mg/kg bw as recommended by the respective guideline. The dose level was 300 mg/kg bw (1st, 2nd step), 2000 mg/kg bw (3rd, 4th step) and 3 animals were used for each step. No mortality was observed. Clinical signs related with the substance were not observed. All animals gained body weight. There were no necropsy findings. Based on these results
Azo zinc complex Pigment - Melamine compound is evaluated to be of low acute oral toxicity with LD50 > 2000 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- This is the only available study which is performed according to OECD TG 423 under GLP conditions and therefore evaluated with Klimisch score 1
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 guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Principles of method if other than guideline:
- Male and female rats were exposed nose-only to 2590 mg (maximum attainable concentration) of the test substance/m³ for 4 hours. Mortality, clinical signs, reflex measurements rectal temperature and body weights were examined during the 14 days post observation period. A gross-pathological examination was performed on day 14 after exposure to the test item. To identify exposure-related effects, comparisons with vehicle control were performed. This control was exposed to an atmosphere using essentially similar exposure conditions as were used for the test item.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- 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:
- 0 mg/m³ (control group)
2590 mg/m³ (test group); 2590 mg/m³ was the maximum attainable concentration) - No. of animals per sex per dose:
- N /Group/sex Concentration (mg/m³)
1/m 0
2/m 2590
1/w 0
2/w 2590 - Control animals:
- yes
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- >= 2 590 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: 2590 mg/m³ was the maximum attainable concentration.
- Executive summary:
A study on the acute inhalation toxicity of Zinc-Azo barbituric acid / Melamine (henceforward referred to as test item) in 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). One group of female and male rats was nose-only exposed to the solid aerosol of the test item at the maximum attainable concentration of 2590 mg/m³ in the animals breathing zone (limit test). In order to achieve the required mass median aerodynamic diameter (MMAD) the test item was micronized using a ball-mill. Rats of the control group were exposed to air under otherwise identical circumstances.
The results can be summarized as follows:
The respirability of the aerosol was adequate and in compliance of test guidelines [the mass median aerodynamic diameter (MMAD) was 3.86 µm, the geometric standard deviation (GSD) was 2.59]. Efforts have been made to generate the maximum attainable concentration of 2590 mg/m³ test item in consideration of particle size distribution according OECD test guideline 403.
Mortality did not occur during the course of the study. All rats exposed to 2590 mg/m³ revealed clinical symptoms (e.g. bradypnea, labored breathing, irregular breathing, motility reduced, atony, high-legged gait, cyanosis, piloerection, haircoat ungroomed, fur orange stained, reduced reflexes). Furthermore animals exposed to the test item showed significant reduction in incremental body weight gain and absolute body weight when compared to control animals as well as significant decreased body temperatures in comparison to controls. Gross pathological findings were seen in all six animals exposed to 2590 mg/m3 on day 14 (light-colored areas and orangecolored areas in the lungs, orange discolorations in the lung-associated lymph nodes).
In summary, there is evidence of low acute inhalation toxicity in rats after exposure (4h) of the aerosolized test item. The LC50 is> 2590 mg/m³.
Reference
One group of female and male rats was nose-only exposed to the solid aerosol of the test item at the maximum attainable concentration of 2590 mg/m³ in the animals breathing zone (limit test). In order to achieve the required mass median aerodynamic diameter (MMAD) the test item was micronized using a ball-mill. Rats of the control group were exposed to air under otherwise identical circumstances.
The results can be summarized as follows:
The respirability of the aerosol was adequate and in compliance of test guidelines [the mass median aerodynamic diameter (MMAD) was 3.86 µm, the geometric standard deviation (GSD) was 2.59]. Efforts have been made to generate the maximum attainable concentration of 2590 mg/m³ test item in consideration of particle size distribution according OECD test guideline 403.
Mortality did not occur during the course of the study. All rats exposed to 2590 mg/m³ revealed clinical symptoms (e.g. bradypnea, labored breathing, irregular breathing, motility reduced, atony, high-legged gait, cyanosis, piloerection, haircoat ungroomed, fur orange stained, reduced reflexes). Furthermore animals exposed to the test item showed significant reduction in incremental body weight gain and absolute body weight when compared to control animals as well as significant decreased body temperatures in comparison to controls. Gross pathological findings were seen in all six animals exposed to 2590 mg/m3 on day 14 (light-colored areas and orangecolored areas in the lungs, orange discolorations in the lung-associated lymph nodes).
In summary, there is evidence of low acute inhalation toxicity in rats after exposure (4h) of the aerosolized test item. The LC50 is> 2590 mg/m³.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 2 590 mg/m³
- Quality of whole database:
- This is the only available study which is performed according to OECD TG 403 under GLP conditions and therefore evaluated with Klimisch score 1
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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP condition
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- 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:
- Age at study initiation: 7 weeks
- Weight at study initiation: males,206.6 g-215.0 g; females 209.7 g-229.2 g
- Fasting period before study: no data
- Housing: individually
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: - Type of coverage:
- semiocclusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on dermal exposure:
- The test substance was applied uniformly over an area which was approximately 10% of the total body surface area. Test substance were held in contact with the skin with a porous gauze dresssing and non-irritating tape throughout the 24-hour exposure period.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The test substance (2000 mg/kg bw) was applied uniformly over an area which was approximately 10% of the total body surface area. Test substance were held in contact with the skin with a porous gauze dresssing and non-irritating tape throughout the 24-hour exposure period. The wrappings were removed at 24 hours after applicatiopn. the applied areas were washed out gently with distilled water. the animals were observed for clinical signs and mortality and changes of body weight over a period of 14 days.
- Statistics:
- statistical analysis were performed by comparing the treatment group and the control group. Variance of numerical data was checked by F-test; then the student t-test was conducted to determine the singnificant difference between two groups
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: no clinical signs, no mortality, body weight gain, no findings at necropsy
- Mortality:
- No death occurred in all animals during the experimental period
- Clinical signs:
- clinical signs related with the substance wer not observed in any amimals during the observation period
- Body weight:
- all living animals showed the normal increase in body weight
- Gross pathology:
- In all animals there were no lesons caused by administration of test substance
- Executive summary:
Acute dermal toxicity was examined in male and female Sprague-Dawley rats in accordance with OECD TG 402 under GLP conditions.The test substance (2000 mg/kg bw) was applied uniformly over an area which was approximately 10% of the total body surface area. Test substance were held in contact with the skin with a porous gauze dresssing and non-irritating tape throughout the 24-hour exposure period. The wrappings were removed at 24 hours after applicatiopn. the applied areas were washed out gently with distilled water. the animals were observed for clinical signs and mortality and changes of body weight over a period of 14 days.
No mortality was observed in the present study. Clinical signs related with the substance were not observed in any animal during the observaion period. All tested animals showed normal gains in body weight. In all animals there were no necropsy findings caused by administration of test substance.
Based on these results the LD50 value was considered to be higher than 2000 mg/kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- This is the only available study which is performed according to OECD TG 402 under GLP conditions and therefore evaluated with Klimisch score 1
Additional information
ACUTE TOXICITY: ORAL
The acute oral toxicity was tested in female rats using the acute toxic class method according to OECD TG 423 under GLP conditions. Azo zinc complex Pigment - Melamine compound was formulated with water for injection and given only once by oral gavage. Starting dose level was selected 300 mg/kg bw as recommended by the respective guideline. The dose level was 300 mg/kg bw (1st, 2nd step), 2000 mg/kg bw (3rd, 4th step) and 3 animals were used for each step. No mortality was observed. Clinical signs related with the substance were not observed. All animals gained body weight. There were no necropsy findings. Based on these results Azo zinc complex Pigment - Melamine compound is evaluated to be of low acute oral toxicity with LD50 > 2000 mg/kg bw.
ACUTE TOXICITY: INHALATION
A study on the acute inhalation toxicity of Azo zinc complex Pigment - Melamine in rats has been conducted in accordance with OECD TG 403 under GLP conditions. One group of female and male rats was nose-only exposed to the solid aerosol of the test item at the maximum attainable concentration of 2590 mg/m³ in the animals breathing zone (limit test).
Mortality did not occur during the course of the study. All rats exposed to 2590 mg/m³ revealed clinical symptoms (e.g. bradypnea, labored breathing, irregular breathing, motility reduced, atony, high-legged gait, cyanosis, piloerection, haircoat ungroomed, fur orange stained, reduced reflexes). Furthermore animals exposed to the test item showed significant reduction in incremental body weight gain and absolute body weight when compared to control animals as well as significant decreased body temperature in comparison to controls. Gross pathological findings were seen in all six animals exposed to 2590 mg/m3 on day 14 (light-colored areas and orange colored areas in the lungs, orange discolorations in the lung-associated lymph nodes).
Azo zinc complex Pigment - Melamine compound is evaluated to be of low acute inhalation toxicity with LC50 > 2590 mg/m³.
AUTE TOXICITY: DERMAL
Acute dermal toxicity was examined in male and female Sprague-Dawley rats in accordance with OECD TG 402 under GLP conditions. Azo zinc complex Pigment - Melamine (2000 mg/kg bw) was applied uniformly over an area which was
approximately 10% of the total body surface area. Test substance was held in contact with the skin with a porous gauze dressing and non-irritating tape throughout the 24-hour exposure period. The wrappings were removed at 24 hours after application. The applied areas were washed out gently with distilled water. The animals were observed for clinical signs and mortality and changes of body weight over a period of 14 days.No mortality was observed in the present study. Clinical signs related with the substance were not observed in any animal during the observation period. All tested animals showed normal gains in body weight. In all animals there were no necropsy findings caused by administration of test substance.
Based on these results the LD50 value was considered to be higher than 2000 mg/kg bw
Justification for selection of acute toxicity – oral endpoint
This is the only available study which is performed according to OECD TG 423 under GLP conditions and therefore evaluated with Klimisch score 1
Justification for selection of acute toxicity – inhalation endpoint
This is the only available study which is performed according to OECD TG 403 under GLP conditions and therefore evaluated with Klimisch score 1
Justification for selection of acute toxicity – dermal endpoint
This is the only available study which is performed according to OECD TG 402 under GLP conditions and therefore evaluated with Klimisch score 1
Justification for classification or non-classification
Based on the results of the available studies (LD50 (oral, dermal) > 2000 mg/kg bw; LD50 (inhalation) > 2590 mg/m³ (maximum attainable concentration)) a classification is not required.
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