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Description of key information

In an OECD Test Guideline 423 study, to GLP, the acute oral LD50 value of dihydrogen hexahydroxyplatinate compound with 2-aminoethanol (1:2) was determined to exceed 2000 mg/kg bw following gavage administration in rats (Antonelli, 2001).

 

No relevant acute dermal or inhalation toxicity data were identified.

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:
19 April - 10 October 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Study conducted according to GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Italy, S.r.l., 33049 San Pietro al Natisone (UD), Italy
- Age at study initiation: approx. 5-6 weeks
- Weight at study initiation: 126-150 g
- Fasting period before study: overnight
- Housing: polycarbonate cages with stainless steel mesh lid and floor
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To:
Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5%
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg
- Justification for choice of vehicle: not stated
- Lot/batch no. (if required): not stated
- Purity: not stated

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual): dissolution/suspension
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1, 2 and 4 hours after dosing and then daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
None
Clinical signs:
other: Not applicable - no clinical signs observed
Gross pathology:
No adverse effects observed
Other findings:
No adverse events detected for either sex
Interpretation of results:
GHS criteria not met
Conclusions:
The acute oral LD50 value of dihydrogen hexahydroxyplatinate compound with 2-aminoethanol (1:2) was determined to exceed 2000 mg/kg bw following gavage administration in rats.
Executive summary:

In an OECD Test Guideline 423 study, to GLP, dihydrogen hexahydroxyplatinate compound with 2-aminoethanol (1:2) was studied for acute toxicity after single oral administration in Sprague-Dawley rats.

The test substance was administered by stomach tube at a dose of 2000 mg/kg bw to groups of rats (3/sex). No mortality was observed and there were no clinical signs or body weight changes at the end of the 14-day observation period. Subsequent necropsy revealed no gross abnormalities.

The acute oral LD50 value of dihydrogen hexahydroxyplatinate compound with 2-aminoethanol (1:2) was determined to exceed 2000 mg/kg bw.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Overall, good-quality database which meets REACH Standard Information Requirements.

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.

 

In an OECD Test Guideline 423 study, to GLP,dihydrogen hexahydroxyplatinate compound with 2-aminoethanol (1:2)was studied for acute toxicity after single oral administration in Sprague-Dawley rats. The test substance was administered by stomach tube (in carboxymethyl cellulose) at a dose of 2000 mg/kg bw to groups of rats (3/sex).No mortality was observed and there were no clinical signs or body weight changes at the end of the 14-day observation period. Subsequent necropsy revealed no gross abnormalities. The acute oral median lethal dose (LD50) of dihydrogen hexahydroxyplatinate compound with 2-aminoethanol (1:2) was determined to exceed 2000 mg/kg bw in male and female rats (Antonelli, 2001).

 

No relevant acute dermal or inhalation toxicity data were identified. However, acute toxicity testing by a second route is not considered appropriate as dihydrogen hexahydroxyplatinate compound with 2-aminoethanol (1:2) is considered corrosive to the skin.

Justification for classification or non-classification

Based on the results of the available and reliable acute oral rat study, dihydrogen hexahydroxyplatinate compound with 2-aminoethanol (1:2)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.