Registration Dossier

Administrative data

Description of key information

The acute oral LD50 of ruthenium (IV) oxide hydrate in rats was found to be greater than 2000 mg/kg bw (Collier, 1982a).

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:
13 January 1982 – 4 February 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Although no indication that a specific guideline was followed, the study was to GLP, and appears scientifically acceptable and well reported.
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
A single acute oral administration of ruthenium (IV) oxide was given to rats at 2000 mg/kg bw (the highest dose causing no deaths in a range-finding study).
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Tuck & Sons Ltd, Battlesbridge, Essex
- Weight at study initiation: 172-225 g
- Fasting period before study: overnight (16-20 hrs) fast directly before treatment
- Housing: maximum of 5 rats (of onesex) in polypropylene cages
- Diet: ad libitum rat diet supplied by Nottingham University, School of Agriculture, Sutton Bonington, Near Loughborough, Leics
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Air changes (per hr): minimum of 20 air changes per hr
- Photoperiod (hrs dark / hrs light): 12 hrs light, 12 hrs dark with no daylight
Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100 mg/ml
- Amount of vehicle (if gavage): 0.25-20.0 ml/kg

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg
Doses:
In the range-finding study, male and female rats were administered 25, 50, 200, 500 or 2000 mg/kg bw using an all metal stomach tube. In the main study male and female rats were administered 2000 mg/kg bw.
No. of animals per sex per dose:
One rat/sex/dose in the range finding study, five rats/sex/dose in the main study.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: ½, 1 and 4 hrs following dosing and then once daily for 14 days.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Statistics:
Acute oral median lethal dose (LD50)
Preliminary study:
In the range-finding study, no deaths were recorded within the 5 day observation period.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths were reported in the range-finding or the main study throughout the 5-day and 14-day observation periods respectively.
Clinical signs:
Subdued activity and pilar erection within the first hr were the only clinical effects seen.
Body weight:
Not reported.
Gross pathology:
Not reported.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a GLP study, similar/equivalent to OECD guidelines, the acute oral LD50 of ruthenium (IV) oxide hydrate in rats was found to be greater than 2000 mg/kg bw.
Executive summary:

Ruthenium (IV) oxide hydrate was tested for its acute oral toxicity in rats, in a GLP study similar/equivalent to OECD Test Guideline 401. In a range finding study, one male and one female rat/group were administered 25, 50, 200, 500 or 2000 mg ruthenium (IV) oxide hydrate/kg bw by stomach tube. No deaths were recorded within the 5-day observation period and, therefore, in the main study, 5 rats/sex were given 2000 mg/kg bw (the highest dose causing no deaths in the range-finding study) by stomach tube. No deaths were again recorded during the 14-day observation period.

 

Based on the results of this study, ruthenium (IV) oxide should not be classified for acute oral toxicity according to EU CLP criteria (EU 1272/2008).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
Only very limited data are available on ruthenium (IV) oxide, relating to eye irritation and acute oral toxicity. No adverse effects were observed.

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

In a GLP study, similar/equivalent to OECD test guideline 401, no deaths were recorded in the 14-day observation period following the administration of ruthenium (IV) oxide to rats (5/sex) at the limit dose of 2000 mg/kg bw by stomach tube (Collier, 1982a).

Justification for classification or non-classification

Based on the results of the available and reliable acute oral rat study, ruthenium (IV) oxide does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008).

No evidence of specific target organ toxicity was noted. As such, classification for STOT-SE is not considered appropriate.