Rhodium chloride (RhCl3), hydrate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 March - 30 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 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 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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, 13465-43-5

IUPAC Name:

20765-98-4, 13465-43-5

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Savo Ivanovas med. , Versuchstierzuchten GmbH, D-7940 Kisslegg im Allgäu
- Age at study initiation: Males, 3-4 months; females, 2-4 months
- Weight at study initiation: Males, 2.75-3.00 kg; females, 2.15-2.75 kg
- Fasting period before study: On the day of treatment
- Housing: Individually housed in high-grade steel cages
- Diet (e.g. ad libitum): Ad libitum standard diet, ssniff K “special diet for rabbits” supplied by ssniff Spezialfutter GmbH, D-4770 Soest
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Animals kept for 5 days under test conditions before application of the test material

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5-23.5
- Humidity (%): 45-60
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: No data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Remarks:

moistened with water

Details on dermal exposure:

TEST SITE
- Area of exposure: No data
- % coverage: No data
- Type of wrap if used: No data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, washed off with water
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): Not applicable
- Constant volume or concentration used: Not applicable

VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution): Not applicable
- Purity: Not applicable

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 male and 3 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 21-27 days
- Frequency of observations and weighing: Observations 6-8 hours after application, then twice daily (once daily at weekends), body weights measured directly before, and 7 and 14 days after, application.
- 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 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:

Not applicable (Limit test acute dermal LD50)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

One of the male rabbits died 3 days after application of the test material. No deaths were noted amongst the females.

Clinical signs:

other: One male was in poor general health (prior to death). No symptoms in the remaining animals.

Gross pathology:

In the male that died, observations included bleeding in the pelvic area and brittle bones as well as liver and kidney damage. Two hours after death, the blood still showed no tendency to coagulate.

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In a guideline acute dermal toxicity study, conducted to GLP, the median lethal dose (LD50) of rhodium (III) chloride hydrate was found to exceed 2000 mg/kg bw following a 24-hour occlusive application in rabbits.

Executive summary:

In an acute dermal limit test, conducted according to OECD Test guideline 402 and to GLP, 5 male and 3 female New Zealand White rabbits received a single dermal application of rhodium (III) chloride hydrate (moistened with water) at 2000 mg/kg bw for 24 hours (under occlusion).

 

A single male died at this dose 3 days after application, exhibiting reduced body weight as well as effects on the liver, kidney and blood. No toxicity was apparent in the remaining animals. The acute dermal median lethal dose (LD50) of rhodium (III) chloride hydrate is greater than 2000 mg/kg bw in rabbits.

 

Based on the results of this study, rhodium (III) chloride hydrate does not need classification for acute dermal toxicity according to EU CLP criteria (EC 1272/2008).