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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:
2012
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

Constituent 1
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 %

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