Triammonium hexachlororhodate

Endpoint summary

Description of key information

The acute oral LD50 of ammonium hexachlororhodate (III) was established to be 1844 and 2571 mg/kg bw in male and female rats, respectively.  An LD50 of 2182 mg/kg bw was calculated on analysis of the data for both sexes together (Dreher, 1989).
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:

15 September-12 October 1989

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

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:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin & Kingman Ltd., Grimston, Aldborough, Hull, U.K.
- Age at study initiation: Main study: Approximately 5-8 weeks old
- Weight at study initiation: Main Study: Males, 122-173 g; Females, 120-173 g
- Fasting period before study: overnight
- Housing: In groups of up to five by sex in solid-floor polypropylene cages with sawdust bedding.
- Diet (e.g. ad libitum): Ad libitum Rat and Mouse expanded diet No. 1, Special Diet Services Limited, Witham, Essex, U.K.
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-24ºC
- Humidity (%): 54-64%
- Air changes (per hr): Approximately 15 changes/hr
- Photoperiod (hrs dark / hrs light): 12 hrs darkness/12 hrs light

IN-LIFE DATES: From: To:

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle:Main study: 100, 144.2, 208, 300 mg/ml
- Amount of vehicle (if gavage):Main study: 10 ml/kg bw
- Justification for choice of vehicle: no data
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED:Main study 10 ml/kg bw

DOSAGE PREPARATION (if unusual):

Doses:

Range-finding study: 500, 1000, 3000, or 5000 mg/kg bw
Main study: 1000, 1442, 2080 or 3000 mg/kg bw

No. of animals per sex per dose:

Range-finding study: One rat/sex/dose
Main study: Five rats/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: Main study:14 days (range-finding study: 5 days)
- Frequency of observations and weighing: Main study: animals observed 1 and 4 hrs after dosing and subsequently once daily for 14 days. Individual bodyweights were recorded on day of treatment (day 0), days 7 and 14, or at death (range-finding study: animals were observed at 1 and 4 hrs and then daily for 5 days; weighed before dosing).
- Necropsy of survivors performed: yes
- Other examinations performed: none

Statistics:

Probit analysis (Finney, 1971)

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 182 mg/kg bw

95% CL:

1 814 - 3 211

Sex:

male

Dose descriptor:

LD50

Effect level:

1 844 mg/kg bw

95% CL:

1 509 - 2 254

Sex:

female

Dose descriptor:

LD50

Effect level:

2 571 mg/kg bw

95% CL:

1 553 - 4 256

Mortality:

In the range-finding study, both rats died on the day of treatment in the 3000 and 5000 mg/kg bw dose level groups. No deaths were observed in the 500 and 1000 mg/kg bw dose level groups over the five-day observation period.

In the main study, no deaths were observed, over the 14-day observation period, in groups of five animals/sex treated at 1000 mg/kg bw. Deaths were noted at between 4 hrs and two days after treatment at the higher tested dose levels. One male and one female died in the 1442 mg/kg bw treatment groups. Three males and two females died after treatment with the 2080 mg/kg bw dose level. All five males and three females died at the high dose level of 3000 mg/kg bw.

Clinical signs:

In the main study, signs of toxicity were noted in all dose groups and included hunched posture and pilo-erection. In addition, lethargy and ataxia were seen in the animals in the 2080 and 3000 mg/kg bw dose groups. At the highest tested dose of 3000 mg/kg bw, decreased respiratory rate and ptosis were also seen. Surviving animals appeared normal two days after treatment.

Body weight:

Data for individual bodyweights and weekly bodyweight gains are tabulated. The authors do not comment on the presented data.

Gross pathology:

Gross necropsy of animals that died during the study revealed abnormally red lungs, dark liver and haemorrhage of the glandular gastric epithelium. Haemorrhage of the small intestine was also noted in one male from the 3000 mg/kg bw treatment group. No abnormalities were seen at necropsy of the animals that survived during the 14-day observation period.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of ammonium hexachlororhodate (III) was established to be 1844 and 2571 mg/kg bw in male and female rats, respectively. An LD50 of 2182 mg/kg bw was calculated on analysis of the data for both sexes together.

Executive summary:

The acute oral toxicity of ammonium hexachlororhodate (III) was investigated in an OECD Test Guideline 401 study, conducted according to GLP. The test substance was administered by oral stomach tube to Sprague-Dawley rats (5/sex/dose) at 1000, 1442, 2080 or 3000 mg/kg bw, based on the results of a range-finding study, and animals were observed for 14 days.

 

No mortality was observed at the lowest dose and a single male and female died at 1442 mg/kg bw. Three males and two females died at 2080 mg/kg bw, while all animals died at the top dose. Signs of toxicity were noted in all dose groups and included hunched posture and pilo-erection. In addition, lethargy and ataxia were seen in the animals in the 2080 and 3000 mg/kg bw dose groups. At the highest tested dose of 3000 mg/kg bw, decreased respiratory rate and ptosis were also seen. Surviving animals appeared normal two days after treatment. Gross necropsy of animals that died during the study revealed abnormally red lungs, dark liver and haemorrhage of the glandular gastric epithelium. Haemorrhage of the small intestine was also noted in one male from the 3000 mg/kg bw treatment group. No abnormalities were seen at necropsy of the animals that survived during the 14-day observation period. 

 

Using the probit method, the acute oral LD50 for ammonium hexachlororhodate (III) was calculated to be 2571 (1553-4256, 95% confidence limit) mg/kg bw in female rats and 1844 (1509-2254, 95% confidence limit) mg/kg bw in males. An LD50 of 2182 (1814-3211, 95% confidence limit) mg/kg bw was calculated on analysis of the data for both sexes together. The study authors do not comment on the potentially greater sensitivity to the test substance shown by the male animals.

 

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:

2 182 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 acute toxicity human data were identified.

 

The acute oral toxicity of ammonium hexachlororhodate (III) was investigated in an OECD Test Guideline 401 study, conducted according to GLP. The test substance was administered by oral stomach tube to Sprague-Dawley rats (5/sex/dose) at 1000, 1442, 2080 or 3000 mg/kg bw, based on the results of a range-finding study, and animals were observed for 14 days. No mortality was observed at the lowest dose and a single male and female died at 1442 mg/kg bw. Three males and two females died at 2080 mg/kg bw, while all animals died at the top dose. Signs of toxicity were noted in all dose groups and included hunched posture and pilo-erection. In addition, lethargy and ataxia were seen in the animals in the 2080 and 3000 mg/kg bw dose groups. At the highest tested dose of 3000 mg/kg bw, decreased respiratory rate and ptosis were also seen. Surviving animals appeared normal two days after treatment. Gross necropsy of animals that died during the study revealed abnormally red lungs, dark liver and haemorrhage of the glandular gastric epithelium. Haemorrhage of the small intestine was also noted in one male from the 3000 mg/kg bw treatment group. No abnormalities were seen at necropsy of the animals that survived during the 14-day observation period. Using the probit method, the acute oral LD50 for ammonium hexachlororhodate (III) was calculated to be 2571 mg/kg bw in female rats and 1844 mg/kg bw in males. An LD50 of 2182 mg/kg bw was calculated on analysis of the data for both sexes together. The study authors did not comment on the potentially greater sensitivity to the test substance shown by the male animals (Dreher, 1989).

 

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 study in rats, triammonium hexachlororhodate 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.