Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Reference substance name:
Reference substance 001
Cas Number:
15336-18-2
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Ammonium hexachlororhodate (III)
- Substance type: red coloured powder
- Physical state: solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date: no data
- Lot/batch No.: S 071559
- Expiration date of the lot/batch: no data
- Stability under test conditions: not determined
- Storage condition of test material: room temperature
- Other: Date of arrival: 8 August 1989. Container: plastic flip-top jar.

Test animals

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:

Administration / exposure

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)

Results and discussion

Effect levelsopen allclose all
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.

Applicant's summary and conclusion

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).