Registration Dossier
Registration Dossier
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EC number: 619-905-2 | CAS number: 915416-45-4
Endpoint summary
Administrative data
Description of key information
LD50 > 2000 mg/kg bw
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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: TECAM Animal Facility (S. Roque, SP).
- Age at study initiation: 9 weeks
- Weight range at study initiation: not greater than 20 percent of the mean weight
- Housing: Animals were housed using conventional polypropilene rodent cages (Beiramar, CXBHG, 4 1 X 34 X 16cm) with three animals per cage.
- Diet (e.g. ad libitum): Pelleted commercial diet for the species (Biobase Biotec) was provided ad libitum
- Water (e.g. ad libitum): Filtered water was provided ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 64 (average)
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
Test substance was applied diluted in corn oil (dilution concentration was 500 mg/mL). - Doses:
- 2000 mg/kg bw/day
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed individually after dosing during the first 24 hours with special attention given during the first 4 hours (day 1). Daily thereafter.
- Frequency of weighing: before substance administration. weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology - Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortality
- Clinical signs:
- no signs of evident toxicity
- Body weight:
- body weight changes within the range of physiological variability.
- Gross pathology:
- No macroscopic changes were observed in any of the major organs of the examined animals.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the data available, the classification criteria according to Regulation (EC) 1272/2008 (CLP) are not met. Therefore, non-classification is warranted.
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