Dihydrogen hexahydroxyplatinate, compound with 2-aminoethanol (1:2)

Endpoint summary

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.