Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non-guideline, experimental study, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A single acute oral administration of ammonium perrhenate was given to rats in a range-finding study at doses of up to 2000 mg/kg bw. A further (main) study was planned using the highest dose level causing no deaths in the range-finding study, however further samples of the test material were unavailable.
GLP compliance:
no
Remarks:
Conducted prior to requirement for GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ammonium perrhenate
- Substance type: white crystalline solid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent
- Age at study initiation: “young adult”
- Weight at study initiation: 175-240 g
- Fasting period before study: overnight fast
- Housing: 5 rats of one sex in polypropylene cages
- Diet: ad libitum oxoid maintenance diet supplied by Herbert C. Styles (Bewdley) Ltd
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): “thermostatically controlled room”
- Photoperiod (hrs dark / hrs light): “controlled lighting conditions”

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
vegetable oil
Details on oral exposure:
The dose was administered by a single peroral injection using a metal cannula. The test material was dissolved in vegetable oil on a weight/volume basis to contain the required dose per kg bw in 10 ml of the vegetable oil.
Doses:
Male and female rats were administered 25, 50, 200, 500 or 2000 mg/kg bw.
No. of animals per sex per dose:
One rat/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: immediately after dosing, 4 hrs after dosing, and daily for 14 days.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs
Statistics:
None

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths were reported within the 14 day observation period.
Clinical signs:
No overt signs of toxicity were reported within the 14 day observation period.
Body weight:
Not reported
Gross pathology:
Not reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral median lethal dose (LD50) of ammonium perrhenate in the rat was found, in a range-finding study, to be >2000 mg/kg bw.
Executive summary:

In a range-finding study, one male and one female rat/group were administered 25, 50, 200, 500 or 2000 mg ammonium perrhenate/kg bw by stomach tube. No deaths were seen in either sex at any dose level. A further study was intended using groups of 5 male and 5 female rats and treating them at the highest dose level causing no deaths in the range-finding study (i.e. 2000 mg/kg bw). However, due to the unavailability of the test material, this was not possible.

 

The study authors concluded that “subject to main study confirmation, the results suggest that the LD50 …. may be in excess of 2000 mg/kg body weight”, and classed the test substance according to Hodge and Sterner (1943) as “slightly toxic”.