Rhodium chloride (RhCl3), hydrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8-24 April 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, to GLP. It should be noted that this record was produced using an English translation of the study report that was originally written in German.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Rhodium (III) chloride hydrate

IUPAC Name:

Rhodium (III) chloride hydrate

Constituent 2

Reference substance name:

20765-98-4, 13569-65-8

IUPAC Name:

20765-98-4, 13569-65-8

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Rhodium (III) chloride hydrate
- Substance type: No data
- Physical state: Dark red crystals
- Analytical purity: 99.5% (38.3% Rh)
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: Ir, 0.005%; Ag, 0.002%; Cu 0.001%; Ca, 0.005%; Mg, 0.002%; Si, 0.003%
- Isomers composition: Not applicable
- Purity test date: 18 February 1986
- Lot/batch No.: 27461
- Expiration date of the lot/batch: No data
- Stability under test conditions: According to information of the sponsor, the test substance was stable throughout the experimental period
- Storage condition of test material: Room temperature

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: Winkelmann Versuchstierzucht GmbH & Co. KG., D-4799 Borchen
- Age at study initiation: Males, 49-52 days; females, 63-65 days
- Weight at study initiation: Males, 128-154 g; females, 129-149 g
- Fasting period before study: 16 hr
- Housing: Individually housed in Macrolon cages, type II
- Diet (e.g. ad libitum): Standard diet ad libitum (ssniff (R), "Special diet for rats"; Fa. Ssniff Spezialfutter GmbH, D-4770 Soest)
- Water (e.g. ad libitum): Water was provided ad libitum in drinking water quality of the Stadtwerke Bielefeld (Municipal Works)
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 50 ± 10
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 215 mg/mL
- Amount of vehicle (if gavage): 2.15, 3.16, 4.64 and 10.0 mL/kg bw
- Justification for choice of vehicle: Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Aqueous solution

MAXIMUM DOSE VOLUME APPLIED: 2150 mg/kg bw

DOSAGE PREPARATION (if unusual): Not applicable

Doses:

464, 681, 1000, or 2150 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for the first 6-8 hrs after dosing and were then checked once-twice daily. Animals were weighed weekly on days 0, 7 and 14 of the study
- Necropsy of survivors performed: yes (Gross necropsy was performed on all animals that died during the course of the study and on surviving animals that were killed at the end of the 14-day observation period. External appearance, body orifices, body cavities (thoracic and abdominal) and their contents were examined macroscopically)
- Other examinations performed: clinical signs, body weight

Statistics:

Data was evaluated by probit analysis with a confidence limit of 95%

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

753 mg/kg bw

Based on:

test mat.

95% CL:

>= 536 - <= 3 984

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

1 257 mg/kg bw

Based on:

test mat.

95% CL:

>= 798 - <= 1 981

Mortality:

No deaths were seen in either male or female rats treated at the 464 mg/kg bw dose level. At the 681 mg/kg bw dose level, one female and one male died one and five days after administration respectively. Two males treated at 1000 mg/kg bw died 2 days after treatment, while all five females died between one and three days after treatment at this dose. At the highest tested dose level of 2150 mg/kg bw, all animals died three to six hours after treatment. The remaining animals survived the 14-day observation period.

Clinical signs:

other: No signs of toxicity were observed in any animals treated at the lowest dose level. The clinical signs observed at dose levels of 681 mg/kg bw and above included ataxia, piloerection and decreased muscle tone as well as a general loss of reflexes. Tremo

Gross pathology:

Necropsy of the dead animals revealed reddened mucous membrane of the stomach and intestine and yellow coloured mucous membrane of the intestine resp.. [the gross necropsy is not well reported – possibly due to a poor translation] {no further details discernible from the translated report}

Other findings:

No data

Any other information on results incl. tables

The study authors note “a stronger sensitivity of the females could be derived numerically, no sex specific reaction is presumed under consideration of the mortality data and the confidence limits".

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a guideline acute oral toxicity study, conducted to GLP, respective LD50 values of 753 mg/kg bw (536-3984 mg/kg bw, 95% confidence limit) and 1257 mg/kg bw (798-1981 mg/kg bw, 95% confidence limit) were reported in female and male rats following gavage administration of rhodium (III) chloride (hydrate), and observation for up to 14 days.

Executive summary:

In a standard acute oral toxicity study (conducted to OECD guideline 401 and to GLP), groups of five male and five female rats were administered 464, 681, 1000 on 2150 mg/kg bw of rhodium (III) chloride (hydrate) by stomach tube and observed for 14 days.

All animals in the top dose level as well as 2 males and 5 females given 1000 mg/kg bw died. No mortality was observed at the lowest dose and only a single male and female given 681 mg/kg bw died. Clinical signs of toxicity appeared one hour following administration. The surviving animals did not show any signs of toxicity. Reduced body weight was observed in one female treated at the 681 mg/kg bw dose level. A number of clinical signs were apparent at this dose level and above. Using the prescribed statistical method, the acute oral median lethal dose (LD50) and 95% confidence limits were found to be 1257 (798-1981) mg/kg bw for males and 753 (536-3984) mg/kg bw for females.

Based on the results of this study, rhodium trichloride (hydrate) should be classified for acute oral toxicity (category 4) according to EU CLP criteria (EC 1272/2008).