Registration Dossier
Registration Dossier
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EC number: 942-925-0 | CAS number: -
Acute Toxicity: oral
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Azo zinc complex Pigment - Melamine compound
- IUPAC Name:
- Azo zinc complex Pigment - Melamine compound
- Test material form:
- other: brown powder
- Details on test material:
- Molecular weight 615.79
Lot no.BOS3479-3105
purity/content: 100 %
Constituent 1
Test animals
- 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
Administration / exposure
- 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
Results and discussion
Effect levels
- 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
Applicant's summary and conclusion
- 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
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