Registration Dossier
Registration Dossier
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EC number: 939-559-9 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 Oct 2006 - 09 Nov 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No necropsy performed; not conducted in compliance with GLP; only limited information
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (adopted 17 Dec 2001)
- Deviations:
- yes
- Remarks:
- (no necropsy was performed and no details on test material purity given)
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dehydrate
- IUPAC Name:
- Reaction mass of ammonium diaqua[bis(oxalate)]oxoniobate(1-) hydrate and ammonium hydrogen oxalate oxalic acid (1:1:1) dehydrate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: yes, 12 h pre-dosing until 3 h post-dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23
- Humidity (%): 69
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 and 300 mg/kg bw
- No. of animals per sex per dose:
- - 2000 mg/kg bw: 3 females
- 300 mg/kg bw: 3 males and 3 females - Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Days 1, 7 and 14
- Necropsy of survivors performed: no
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 300 - 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All 3 females treated with 2000 mg/kg bw died on the first day post-dosing.
There was no mortality observed in any of the males or females treated with 300 mg/kg bw throughout the study period. - Clinical signs:
- other: 2/3 females dosed with 2000 mg/kg bw showed prostration and ataxia before death. Animals of the 300 mg/kg bw dose groups did not show any signs of toxicity throughout the study period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- CLP: Acute Oral 4, H302
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