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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

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:
1986
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

Constituent 1
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

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).