Tris(triphenylphosphine)rhodium (I) chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 22-May 6 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was carried out in accordance with the relevant OECD guideline for 1988, the year in which it was performed, and was GLP compliant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

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 (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tris(triphenylphosphine)rhodium (I) chloride

EC Number:

238-744-5

EC Name:

Tris(triphenylphosphine)rhodium (I) chloride

Cas Number:

14694-95-2

Molecular formula:

C54H45ClP3Rh

IUPAC Name:

tris(triphenylphosphine)rhodium (I) chloride

Details on test material:

- Name of test material (as cited in study report): Chlorotris-(triphenylphosphine)-rhodium(I)
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: red powder
- Analytical purity: 11% Rh
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: 6549
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions: According to information from the sponsor, decomposition need to be expected throughout the experimental period [sic].
- Storage condition of test material: room temperature
- Other:pH value: neutral

Test animals

Species:

rat

Strain:

other: Wistar Bor: WISW (SPFTNO)

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, 9 weeks; Females, 10 weeks
- Weight at study initiation: Males, 180-226 g; Females, 147-175 g
- Fasting period before study:16 hrs before treatment
- Housing: Macrolon cages, type II
- Diet (e.g. ad libitum): standard diet ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5-21.5ºC
- Humidity (%): 35-65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 06:00-18:00 hrs artificial lighting; 18:00-06:00 hrs natural light-dark-rhythm

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: aqueous Tylose suspension (1%)

Details on oral exposure:

VEHICLE
- Concentration in vehicle:250 mg/ml
- Amount of vehicle (if gavage): 20 ml/kg bw
- Justification for choice of vehicle: test substance not soluble in water
- Lot/batch no. (if required): no data (Tylose supplied by Hoeschst AG, D-6000 Frankfurt)
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 rats/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were continuously observed for first 4-8 hrs after administration and then twice daily. Bodyweights were recorded at the beginning and at 7 and 14 days after administration of test substance.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No deaths occurred during the 14-day observation period after 5 male and 5 female rats were treated with 5000 mg/kg bw test substance.

Clinical signs:

No systemic toxic effects were observed.

Body weight:

Body weights for the treated animals were reported for days 0, 7 and 14 of the study. Both male and female animals showed increased bodyweights at day 7 and again at day 14. However, bodyweight data for vehicle control animals or historical laboratory data are not provided. The study authors do not comment on bodyweight increases.

Gross pathology:

No abnormalities were detected on gross necropsy at the end of the 14-day observation period. Macroscopic examination included external appearance, body orifices, body cavities (thoracic and abdominal) and their contents).

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 for chlorotris-(triphenylphosphine)-rhodium(I) was established to be above 5000 mg/kg bw in rats.

Executive summary:

The acute oral toxicity of chlorotris-(triphenylphosphine)-rhodium(I) was investigated in an OECD Test Guideline 401 study, conducted according to GLP. Test substance was administered by oral stomach tube to Wistar Bor rats (5/sex) at a limit dose of 5000 mg/kg bw (in aqueous Tylose suspension). Animals were observed daily and weighed weekly. No mortality was observed over the 14-day observation period and no abnormalities were seen at macroscopic post mortem examination. The acute oral LD50 value for chlorotris-(triphenylphosphine)-rhodium(I) in rats was therefore established to be above 5000 mg/kg bw.

Based on the results of this study, no classification is required for acute oral toxicity according to EU CLP criteria (EC 1272/2008).