Tris(triphenylphosphine)rhodium (I) chloride

Endpoint summary

Description of key information

The acute oral LD50 for chlorotris-(triphenylphosphine)-rhodium(I) was established to be above 5000 mg/kg bw in rats (Mayr, 1988a).
No relevant acute dermal or inhalation toxicity data were identified, or are required at this tonnage.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

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

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:

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.

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).

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).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No relevant human acute toxicity data were identified.

 

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 (Mayr, 1988a).

 

No acute dermal or inhalation toxicity data were identified, or are required at this tonnage (1-10 tpa).

Justification for selection of acute toxicity – oral endpoint
OECD guideline study, and the only acute oral toxicity study available.

Justification for classification or non-classification

Based on the results of the available and reliable acute oral rat study, tris(triphenylphosphine) rhodium(I) chloride does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).

 

No clear evidence of specific target organ toxicity was noted. As such, classification for STOT-SE is not considered appropriate.