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Administrative data

Description of key information

In a guideline study, to GLP, the acute oral LD50 of carbonylhydridotris(triphenylphosphane)-rhodium(I) in rats was established to be above 2000 mg/kg bw (Berthold, 1991a).
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:
Not stated
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study, to GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
other: Bor: WISW (SPFCpb)
Sex:
male/female
Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co. KG.

- Age at study initiation: males 8 weeks, females 9 weeks

- Weight at study initiation: males 144-171 g, females 130-156 g

- Fasting period before study: 16 hours

- Housing: Macrolon cages, type 2, with animal bedding chips; 1/cage

- Diet (e.g. ad libitum): Standard diet, Ssniff R, special diet for rats; ad libitum

- Water (e.g. ad libitum): municipal water supply, using an automatic drinking water system with drinking nipples; ad libitum

- Acclimation period: >=5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-23.0

- Humidity (%): 40-65

- Air changes (per hr): not stated

- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: Not stated, but QA inspections on 19-Feb-1991 21-Feb-1991 during the experimental phase

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:

VEHICLE
- Concentration in vehicle: 46.4, 100 and 215 mg/ml

- Amount of vehicle (if gavage): 21.5 ml/kg bw

- Justification for choice of vehicle: not stated

- Lot/batch no. (if required): Tylose® (Tylopur® C 1000 P batch E 084 4357) supplied by Hoechst AG

- Purity: not stated; used at 1% (aqueous)

MAXIMUM DOSE VOLUME APPLIED: 21.5 ml/kg bw

DOSAGE PREPARATION (if unusual): suspended in vehicle immediately before dosing using a homogenizer

CLASS METHOD (if applicable): not applicable

Doses:
1000, 2150 and 4640 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:
- Behaviour, general condition, clinical symptoms: continuous for 4-6 hours after dosing, then once daily
- Mortality: twice daily in working days, once daily otherwise
- Body weight: days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs-yes, body weight-yes, organ weights-no, histopathology-yes (liver and kidney), other-no

Statistics:
LD50 calculated for each sex and for both sexes together with 95% confidence limits by probit analysis
Preliminary study:
not applicable
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 206 mg/kg bw
95% CL:
1 580 - 3 089
Sex:
male
Dose descriptor:
LD50
Effect level:
2 390 mg/kg bw
95% CL:
1 156 - 5 676
Sex:
female
Dose descriptor:
LD50
Effect level:
2 118 mg/kg bw
95% CL:
1 054 - 4 226
Mortality:
Males: 1000 mg/kg bw - 0/5; 2150 mg/kg bw - 3/5 on days 2 and 3; 4640 mg/kg bw - 4/5 on day 2
Females: 1000 mg/kg bw - 0/5; 2150 and 4640 mg/kg bw - 3/5 on days 2 and 3; 4640 mg/kg bw - 5/5 on day 2
Clinical signs:
Males: 1000 mg/kg bw - slight hypokinesia, staggered/restrained gait, diarrhoea, sunken sides; 2150 and 4640 mg/kg bw - slight to severe hypokinesia, staggered/restrained gait, moderate clonic convulsions, decreased muscle tone, loss of righting reflex, loss of corneal reflex, mydriasis, salivation, diarrhoea/soft faces, piloerection, strenuous respiration, sunken sides (2150 mg/kg bw only), ataxia, stiff legs (4640 mg/kg bw only), opisthotonus (2150 mg/kg bw only), low body surface temperature;
Females: 1000 mg/kg bw - restrained gait, sunken sides; 2150 and 4640 mg/kg bw - slight to moderate hypokinesia, staggered/restrained/stilted gait, moderate clonic convulsions, decreased muscle tone, loss of righting reflex, mydriasis (4640 mg/kg bw only), salivation (4640 mg/kg bw only), diarrhoea (2150 mg/kg bw only), piloerection, strenuous respiration (4640 mg/kg bw only), sunken sides, ataxia, stiff legs (4640 mg/kg bw only), low body surface temperature, green urine (2150 mg/kg bw only)
Body weight:
Males and females: 1000 mg/kg bw - gained weight during the observation period; 2150 and 4640 mg/kg bw - survivors gained weight during the study; animals that died had lost weight
Gross pathology:
1000 mg/kg bw: no changes in any organs
2150 and 4640 mg/kg bw: stomach - yellow/black contents, black staining and white red discolouration of glandular stomach mucosa, fusion of pyloric stomach/first part of duodenum to liver (1 high dose male only); liver - prominent lobular patter, yellow discolouration of lobus caudatus, pale and soft; kidney (females only) - reddened papillae or cortex/medulla border; bladder - greenish/black discoloured urine
Other findings:
- Organ weights: not recorded

- Histopathology:
- Males - 1000 mg/kg bw: liver - minimal to mild centrolobular hypertrophy;
- Males - 2150 mg/kg bw: liver - minimal to mild centrolobular hypertrophy (surviving animals), mild to marked periportal hepatocellular vacuolization/degeneration and chromatin abnormalities (animals that died); kidney - minimal to mild vacuolization/degeneration of proximal tubular epithelial cells and mild to moderate congestion of the medulla (animals that died);
- Males - 4640 mg/kg bw: liver - mild to marked periportal hepatocellular vacuolization/ degeneration and chromatin abnormalities (animals that died) ; kidney - minimal to mild vacuolization/degeneration of proximal tubular epithelial cells and mild to moderate congestion of the medulla (animals that died)

- Potential target organs: liver and kidney

- Other observations: none

Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 of carbonylhydridotris(triphenylphosphane)-rhodium(I) in rats was established to be above 2000 mg/kg bw.
Executive summary:

The acute oral toxicity of carbonylhydridotris(triphenylphosphane)-rhodium(I) was evaluated in an OECD Test Guideline 401 study, conducted according to GLP. Test substance was administered by oral stomach tube to rats (5/sex/dose) at a single oral gavage dose of 1000, 2150 or 4640 mg/kg bw in 1% carboxymethylcellulose and observed for up to 14 days.

 

LD50 values (with 95% confidence limits) were 2206 (1580-3089) mg/kg bw for both sexes together, 2390 (1156-5676) mg/kg bw for males and 2118 (1054-4226) mg/kg bw for females. A small number of clinical signs were apparent in all dose groups. No macroscopic changes in any organs were observed at 1000 mg/kg bw. At higher doses, there were effects in the stomach, liver and kidneys (females only). Males displayed liver histopathology at all doses and kidney effects at the top dose.

 

The acute oral LD50 of carbonylhydridotris(triphenylphosphane)-rhodium(I) in rats was therefore established to be above 2000 mg/kg bw.

 

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 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 carbonylhydridotris(triphenylphosphane)-rhodium(I) was evaluated in an OECD Test Guideline 401 study, conducted according to GLP. Test substance was administered by oral stomach tube to rats (5/sex/dose) at a single oral gavage dose of 1000, 2150 or 4640 mg/kg bw in 1% carboxymethylcellulose and observed for up to 14 days. LD50 values (with 95% confidence limits) were 2206 (1580-3089) mg/kg bw for both sexes together, 2390 (1156-5676) mg/kg bw for males and 2118 (1054-4226) mg/kg bw for females. A small number of clinical signs were apparent in all dose groups. No macroscopic changes in any organs were observed at 1000 mg/kg bw. At higher doses, there were effects in the stomach, liver and kidneys (females only). Males displayed liver histopathology at all doses and kidney effects at the top two doses. The acute oral LD50 of carbonylhydridotris(triphenylphosphane)-rhodium(I) in rats was therefore established to be above 2000 mg/kg bw (Berthold, 1991a).

 

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, carbonylhydrotris(triphenylphosphine)rhodium 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.