Rhodium acetate

Endpoint summary

Description of key information

The acute oral LD50 of rhodium (III) acetate “brown” was found to be >5000 and 4799 mg/kg bw in male and female rats, respectively (Mayr, 1986a).
The acute dermal LD50 of rhodium (III) acetate “brown” was found to be >2000 mg/kg bw in rabbits (Mayr, 1986b).
No relevant acute 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:

11 March 1986 – 26 March 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD guideline No. 401 and to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

other: Wistar Bor: WISW

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Versuchstierzucht Winkelmann, D-4791 Borchen
- Age at study initiation: males 49-50 days, females 63-64 days
- Weight at study initiation: males 128-157 g, females 128-150 g
- Fasting period before study: 16 hrs
- Housing: individually
- Diet: ad libitum standard diet, ssniff R “special diet for rats” supplied by Firma ssniff Spezialfutter GmbH, D-4770 Soest
- Water: ad libitum
- Acclimation period: at least 5 days before dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Photoperiod (hrs dark / hrs light): 6 am-6 pm fluorescent tube lighting, 6 pm-6 am “natural light-dark-rhythm”

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 215 mg/ml
- Purity: demineralised

MAXIMUM DOSE VOLUME APPLIED: 31.6 ml/kg bw

Doses:

Reported as 2150, 3160, 4640 and 6810 mg/kg bw

No. of animals per sex per dose:

Groups of 5/sex/dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observed 6-8 hours after dosing then twice daily for 14 days or daily on Saturdays, Sundays and public holidays
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

Probit analysis

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: Measured graphically

Sex:

female

Dose descriptor:

LD50

Effect level:

ca. 4 799 mg/kg bw

95% CL:

ca. 1 825 - ca. 22 444

Remarks on result:

other: Measured using Probit analysis

Mortality:

One of the five females given 4640 mg/kg bw died within days [although a summary table suggests that two died within 2-6 days]. At the top dose, 4 of the 5 males died after 330-370 mins or 5-6 days and all five females died after 140-390 mins or 2 days.

Clinical signs:

other: No effects were seen in either the males or females at 2150 or 3160 mg/kg bw. Cyanosis was evident in 2 males and 3 females at 4640 mg/kg bw, and in 2 males and 1 female at 6810 mg/kg bw. The top dose also caused a loss of co-ordination in 2 males and 4 f

Gross pathology:

The intestinal mucous membranes were red or yellow in some of the animals.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral median lethal dose (LD50) of rhodium (III) acetate “brown” was found to be >5000 and 4799 mg/kg bw in male and female rats, respectively.

Executive summary:

The acute oral toxicity of rhodium (III) acetate “brown” was investigated in an OECD Test Guideline 401 study, conducted according to GLP. The test substance was administered by oral stomach tube to rats (5/sex/dose) at 2150, 3160, 4640 or 6810 mg/kg bw and animals were observed for 14 days. Deaths occurred at the top dose in all but one male animal, and in one female at 4640 mg/kg bw. Cyanosis (a blue discolouration of the skin and mucous membranes) was evident from 4640 mg/kg bw, and there were various effects on the nervous system at the top dose.

 

The oral LD50 value was determined to be >5000 mg/kg bw in males (measured graphically) and 4799 mg/kg bw in females (calculated by probit analysis).

 

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:

4 799 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 March 1986 – 1 April 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted according to OECD guideline No. 402 and to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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 in Allgäu
- Age at study initiation: males 3-4 months, females 3 months
- Weight at study initiation: males 2.5-2.65 kg, females 2.25-2.5 kg
- Fasting period before study: food withdrawn on day of treatment
- Housing: individually in wire-bottomed cages
- Diet: ad libitum standard diet, ssniff K “special diet for rabbits” supplied by ssniff Spezialfutter GmbH, D-4770 Soest
- Water: ad libitum
- Acclimation period: at least 5 days before application of test material

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.5-23.5
- Humidity (%): 45-60
- Photoperiod (hrs dark / hrs light): 6 am-6 pm fluorescent tube lighting, 6 pm-6 am “natural light-dark-rhythm”

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: between the shoulder and the hind leg region
- % coverage: no data
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes

VEHICLE
- Amount(s) applied (volume or weight with unit): used to dampen the test material

Duration of exposure:

24 hrs

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 21 days
- Frequency of observations and weighing: observed 6-8 hours after dosing then twice daily for 21 days or daily on Saturdays, Sundays and public holidays; body weight measured once/week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No deaths

Clinical signs:

other: No signs of clinical toxicity seen in either the male or female rabbits.

Gross pathology:

No findings.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal median lethal dose (LD50) of rhodium (III) acetate “brown” was found to be >2000 mg/kg bw in rabbits.

Executive summary:

In an OECD Test Guideline 402 study, conducted according to GLP, the acute dermal toxicity of rhodium (III) acetate “brown” was investigated in New Zealand rabbits received. Animals (3/sex) received a single occlusive skin application of the test item (in water) at a limit dose of 2 g/kg bw. After 24 hours, the dressing was removed and the skin washed. The animals were observed twice daily and any deaths were recorded.

 

No mortality was observed at the limit dose, following the 21-day observation period. Slight transient weight loss was apparent in a single female. The dermal LD50 value was determined to exceed 2000 mg/kg bw.

 

Based on the results of this study, no classification is required for acute dermal toxicity 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

Additional information

No relevant acute toxicity human data were identified.

 

The acute oral toxicity of rhodium (III) acetate “brown” was investigated in an OECD Test Guideline 401 study, conducted according to GLP. The test substance was administered by oral stomach tube to rats (5/sex/dose) at 2150, 3160, 4640 or 6810 mg/kg bw and animals were observed for 14 days. Deaths occurred at the top dose in all but one male animal, and in one female at 4640 mg/kg bw. Cyanosis (a blue discolouration of the skin and mucous membranes) was evident from 4640 mg/kg bw, and there were various effects on the nervous system at the top dose. The oral LD50 value was determined to be >5000 mg/kg bw in males and 4799 mg/kg bw in females (Mayr, 1986a).

 

In an OECD Test Guideline 402 study, conducted according to GLP, the acute dermal toxicity of rhodium (III) acetate “brown” was investigated in New Zealand rabbits received. Animals (3/sex) received a single occlusive skin application of the test item (in water) at a limit dose of 2 g/kg bw. After 24 hours, the dressing was removed and the skin washed. The animals were observed twice daily and any deaths were recorded. No mortality was observed at the limit dose, following the 21-day observation period. Slight transient weight loss was apparent in a single female. The dermal LD50 value was determined to exceed 2000 mg/kg bw (Mayr, 1986b).

 

No acute 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 selection of acute toxicity – dermal endpoint
OECD guideline study, and the only acute dermal toxicity study available.

Justification for classification or non-classification

Based on the results of the available reliable acute oral and dermal studies (in rats and rabbits, respectively), rhodium acetate does not require classification for acute oral or dermal 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.