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EC number: 255-707-9 | CAS number: 42204-14-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 March 1986 – 26 March 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to OECD guideline No. 401 and to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Rhodium(3+) acetate
- EC Number:
- 247-460-0
- EC Name:
- Rhodium(3+) acetate
- Cas Number:
- 42204-14-8
- Molecular formula:
- C6H9O6Rh
- IUPAC Name:
- Rhodium(3+);triacetate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): rhodium (III) acetat “braun”
- Substance type: brown crystal
- Physical state: solid
- Composition of test material, percentage of components: 39.54% Rh
- Lot/batch No.: 6091
- Stability under test conditions: stable throughout the test period
- Storage condition of test material: at room temperature
- Other: soluble in water
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Wistar Bor: WISW
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, D-4791 Borchen
- Age at study initiation: males 49-50 days, females 63-64 days
- Weight at study initiation: males 128-157 g, females 128-150 g
- Fasting period before study: 16 hrs
- Housing: individually
- Diet: ad libitum standard diet, ssniff R “special diet for rats” supplied by Firma ssniff Spezialfutter GmbH, D-4770 Soest
- Water: ad libitum
- Acclimation period: at least 5 days before dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 6 am-6 pm fluorescent tube lighting, 6 pm-6 am “natural light-dark-rhythm”
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 215 mg/ml
- Purity: demineralised
MAXIMUM DOSE VOLUME APPLIED: 31.6 ml/kg bw - Doses:
- Reported as 2150, 3160, 4640 and 6810 mg/kg bw
- No. of animals per sex per dose:
- Groups of 5/sex/dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed 6-8 hours after dosing then twice daily for 14 days or daily on Saturdays, Sundays and public holidays
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- Probit analysis
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Remarks on result:
- other: Measured graphically
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 4 799 mg/kg bw
- 95% CL:
- ca. 1 825 - ca. 22 444
- Remarks on result:
- other: Measured using Probit analysis
- Mortality:
- One of the five females given 4640 mg/kg bw died within days [although a summary table suggests that two died within 2-6 days]. At the top dose, 4 of the 5 males died after 330-370 mins or 5-6 days and all five females died after 140-390 mins or 2 days.
- Clinical signs:
- other: No effects were seen in either the males or females at 2150 or 3160 mg/kg bw. Cyanosis was evident in 2 males and 3 females at 4640 mg/kg bw, and in 2 males and 1 female at 6810 mg/kg bw. The top dose also caused a loss of co-ordination in 2 males and 4 f
- Gross pathology:
- The intestinal mucous membranes were red or yellow in some of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of rhodium (III) acetate “brown” was found to be >5000 and 4799 mg/kg bw in male and female rats, respectively.
- Executive summary:
- The
acute oral toxicity of rhodium (III) acetate “brown” was investigated in
an OECD Test Guideline 401 study, conducted according to GLP. The test
substance was administered by oral stomach tube to rats (5/sex/dose) at
2150, 3160, 4640 or 6810 mg/kg bw and animals were observed for 14 days.
Deaths occurred at the top dose in all but one male animal, and in one
female at 4640 mg/kg bw. Cyanosis (a blue discolouration of the skin and
mucous membranes) was evident from 4640 mg/kg bw, and there were various
effects on the nervous system at the top dose.
The oral LD50 value was determined to be >5000 mg/kg bw in males (measured graphically) and 4799 mg/kg bw in females (calculated by probit analysis).
Based on the results of this study, no classification is required for acute oral toxicity according to EU CLP criteria (EC 1272/2008).
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