Didysprosium trioxide

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1963

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1963

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Reason / purpose for cross-reference:

reference to same study

Principles of method if other than guideline:

The test item was injected into the stomach of mice in increasing quantities.

GLP compliance:

not specified

Species:

mouse

Strain:

not specified

Sex:

not specified

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

Highest dose was 10000 mg/kg bw. No information on lower doses.

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LD0

Effect level:

>= 10 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

None, it was reported that no deleterious effect was observed when administering a dose of 10000 mg/kg bw.

Interpretation of results:

GHS criteria not met

Conclusions:

Up to 10000 mg/kg bw (test item injected into the stomach of mice) has no apparent deleterious effects.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1964

Report date:

1963

Materials and methods

Principles of method if other than guideline:

The test item was administered to guinea pigs at a dose level of 2000 mg/kg every other day for a month via oral gavage. A control group was included.

GLP compliance:

not specified

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:

No further information on test item available.

Test animals

Species:

guinea pig

Strain:

not specified

Details on species / strain selection:

No further data

Sex:

not specified

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Route of administration:

oral: gavage

Details on route of administration:

No data

Vehicle:

other: edulcorated starch paste

Details on oral exposure:

PREPARATION OF DOSING SOLUTIONS:
Test item dust in the required dose was mixed with edulcorated thick starch paste and delivered via syringe to the mouth of the animals.

VEHICLE
Justification for use and choice of vehicle (if other than water): Starch paste for palatability of test substance.

Analytical verification of doses or concentrations:

not specified

Details on analytical verification of doses or concentrations:

During the experiment, each animal received 16-18 g of test item.

Duration of treatment / exposure:

30 days

Frequency of treatment:

Every other day.

Doses / concentrations

Dose / conc.:

2 000 other: mg/kg bw, every other day

No. of animals per sex per dose:

No data

Control animals:

yes, concurrent no treatment

Details on study design:

No data

Positive control:

No data

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Not specified

DETAILED CLINICAL OBSERVATIONS: Not specified

BODY WEIGHT: Not specified

FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Not specified
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified

FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Not specified

WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not specified

OPHTHALMOSCOPIC EXAMINATION: Not specified

HAEMATOLOGY: Yes
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters examined: Hemoglobin, erythrocytes and leukocytes, differential blood count; blood coagulability (prothrombin index)

CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked: Study of the state of the liver and processes of protein metabolism: amino acids in blood serum, protein levels and enzyme levels in blood serum.

URINALYSIS: Yes
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters examined: Study of state of the liver and processes of protein metabolism: amino acids in urine.

NEUROBEHAVIOURAL EXAMINATION: Not specified

IMMUNOLOGY: Not specified

Sacrifice and pathology:

GROSS PATHOLOGY: Not specified

HISTOPATHOLOGY: Yes
- Microscopic investigation of the structure of the internal organs of animals killed after completion of dosing.

Other examinations:

No data

Statistics:

Yes, no further data

Results and discussion

Results of examinations

Clinical signs:

not specified

Mortality:

not specified

Body weight and weight changes:

not specified

Food consumption and compound intake (if feeding study):

not specified

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

no effects observed

Description (incidence and severity):

Statistical analysis of the blood data revealed no significant effects from the exposure to the test item.
No further data.

Clinical biochemistry findings:

no effects observed

Description (incidence and severity):

Statistical analysis of the blood data revealed no significant effects from the exposure to the test item.
No further data.

Urinalysis findings:

no effects observed

Description (incidence and severity):

No further data.

Behaviour (functional findings):

not specified

Immunological findings:

not specified

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Neuropathological findings:

not specified

Histopathological findings: non-neoplastic:

no effects observed

Description (incidence and severity):

Microscopic examination of internal organs revealed no significant findings. No further data.

Histopathological findings: neoplastic:

not specified

Other effects:

not specified

Details on results:

No further data.

Effect levels

Dose descriptor:

NOAEL

Effect level:

>= 2 000 other: mg/kg bw, every other day

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Target system / organ toxicity

Critical effects observed:

no

Applicant's summary and conclusion

Conclusions:

Interpretation of results: study not used for classification due to deficiencies of the study.

The degree of toxicity of the test item to guinea pigs over a 30 day exposure period was found to be negligible, when administering a dose of 2000 mg/kg bw every other day via oral gavage.