Registration Dossier
Registration Dossier
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EC number: 215-947-7 | CAS number: 1458-18-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Start : 12 March 2013 Completion : 28 March 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- The study was carried out based on the guidelines described in:
JMAFF guidelines (2011) including the most recent partial revisions. - GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Methyl 3-amino-5,6-dichloropyrazine-2-carboxylate
- EC Number:
- 215-947-7
- EC Name:
- Methyl 3-amino-5,6-dichloropyrazine-2-carboxylate
- Cas Number:
- 1458-18-0
- Molecular formula:
- C6H5Cl2N3O2
- IUPAC Name:
- methyl 3-amino-5,6-dichloropyrazine-2-carboxylate
- Test material form:
- solid: particulate/powder
- Details on test material:
- Identification: Amiloride Compound 7
Molecular formula: C6H5Cl2N3O2
Molecular weight: 222.03
CAS Number:1458-18-0
Description: Tan powder
Batch: 206-2
Purity/Composition: 99.7 area%
Test substance storage: In refrigerator (2-8°C) protected from light, desiccated
Stability under storage conditions: Stable
Expiry date: 11 May 2014 (Retest date)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: 8 weeks
- Weight at study initiation: Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: 18 hours
- Housing: 3 per same group in stainless steel cage
- Diet (e.g. ad libitum): SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days before
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24°C,
- Humidity (%): 40-70 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/24
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.6 % methyl cellulose aqueous solution
- Details on oral exposure:
- The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The
first group was treated at a dose level of 2000 mg/kg. - Doses:
- 2000 mg/kg.
- No. of animals per sex per dose:
- 3 females per dose
- Control animals:
- yes
- Details on study design:
- The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The
first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals
dosed at one step determined the next step, based on the test procedure defined in the guidelines.
The onset, duration and severity of the signs of toxicity were taken into account for determination of
the time interval between the dose groups.
Results and discussion
- Preliminary study:
- No Data
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: Hunched posture was noted in all animals on Days 1 and/or 2. In addition, piloerection was noted in three females on Day 1.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 value of Amiloride Compound 7 in Wistar rats was established to exceed 2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.
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