Didysprosium trioxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-12-26 to 1991-01-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: FHSA 16 CFR 1500.42

Deviations:

no

Principles of method if other than guideline:

No further data.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Didysprosium trioxide

EC Number:

215-164-0

EC Name:

Didysprosium trioxide

Cas Number:

1308-87-8

Molecular formula:

Dy2O3

IUPAC Name:

dysprosium(3+); oxygen(2-)

Test material form:

solid: particulate/powder

Details on test material:

Name: dysprosium oxide
Purity: 96%
Lot number: #DY-spcl
Appearance: off-white powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hilltop Lab Animals, Scottdale, PA, USA
- Females (if applicable) nulliparous and non-pregnant: No data
- Age at study initiation: No data
- Weight at study initiation: 242-305 g
- Fasting period before study: Yes, 18 hours prior to selection and test initiation. Water was provided ad libitum.
- Housing: Individually in suspended stainless steel caging with mesh floors.
- Diet (e.g. ad libitum): ad libitum, pelleted Purina Rat Chow
- Water (e.g. ad libitum): ad libitum, tap water supplied by automatic water system
- Acclimation period: 49 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68-73°F
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: 1990-12-26 To: 1991-01-09

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% w/w
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): No data

Doses:

5.0 g/kg

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: For signs of gross toxicity and mortality 1 and 2 hours after dosing, and at least once daily thereafter for 14 days. Body weights were recorded initially and at termination.
- Necropsy of survivors performed: No data
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: No data

Statistics:

No data

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived.

Clinical signs:

other: All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects or abnormal behaviour.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The single dose acute oral LD50 of the test item is greater than 5.0 g/kg when administered as a 50% w/w solution with distilled water. Based on these results, the test substance is not to be classified according to CLP Regulation.

Executive summary:

A single dose of 5.0 g/kg of the test item was administered to 10 fasted Sprague-Dawley rats, using 5 animals per sex. Animals were observed for 14 days following dosing. The single dose acute oral LD50 of the test item is greater than 5.0 g/kg when administered as a 50% w/w solution with distilled water.