Yttrium(3+) acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 July 2017 to 02 August 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Version / remarks:

2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Yttrium(3+) acetate

EC Number:

245-612-0

EC Name:

Yttrium(3+) acetate

Cas Number:

23363-14-6

Molecular formula:

C6H9O6Y

IUPAC Name:

yttrium(3+) acetate

Test material form:

solid: particulate/powder

Details on test material:

- Appearance: Solid, crystalline, colourless powder.

Test animals

Species:

rat

Strain:

Wistar

Remarks:

RccHan™:WIST

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 157 to 186 g
- Fasting period before study: overnight before dosing
- Housing: The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with wood flakes.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25 °C
- Humidity: 30 to 70 %
- Air changes: at least fifteen changes per hour
- Photoperiod: lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

VEHICLE
- Justification for choice of vehicle: For the purpose of the study the test material was freshly prepared, as required, as a solution in dimethyl sulfoxide. Dimethyl sulfoxide was used because the test material did not dissolve in distilled water or arachis oil BP.

DOSAGE PREPARATION:
- The test material was formulated within 2 hours of being applied to the test system. It is assumed that the formulation was stable for this duration.

CLASS METHOD
- In the absence of data regarding the toxicity of the test material, 300 mg/kg was chosen as the starting dose. A single animal was treated at 300 mg/kg and observed.

Doses:

300 mg/kg for a single animal, increased to 2000 mg/kg in the absence of toxicity.

No. of animals per sex per dose:

One female at 300 mg/kg.
Five females at 2000 mg/kg.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily for 14 days. Morbidity and mortality checks were made twice daily, early and late during normal working days, and once daily at weekends and public holidays.
- Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: yes, at the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained

Statistics:

No statistical analysis was performed.

Results and discussion

Preliminary study:

The following results were observed for the single female dosed at 300 mg/kg:
- There was no mortality.
- No signs of systemic toxicity were noted during the observation period.
- The animal showed expected gains in body weight over the observation period.
- No abnormalities were noted at necropsy.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

Hunched posture and pilo erection were noted, 4 hours after dosing, in the initial treated animal. There were no signs of systemic toxicity noted in the four additional animals treated at a dose level of 2000 mg/kg

Body weight:

All animals showed expected gains in body weight over the observation period.

Gross pathology:

No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified in accordance with EU criteria

Conclusions:

Under the conditions of this study, the acute oral LD50 value in female Wistar rats was established to exceed 2000 mg/kg body weight.

Executive summary:

The acute oral toxicity of the test material was investigated in the Wistar strain rat in accordance with the standardised guidelines OECD 420 and EU Method B1 bis, under GLP conditions.

Following a sighting test at dose levels of 300 mg/kg and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test material, as a solution in dimethyl sulfoxide, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths in the treated animals. Hunched posture and pilo erection were noted, 4 hours after dosing, in the initial animal treated at a dose level of 2000 mg/kg. There were no signs of systemic toxicity noted in the four additional animals treated at a dose level of 2000 mg/kg and the animal treated at a dose level of 300 mg/kg. All animals showed expected gains in body weight and no abnormalities were noted at necropsy.

Under the conditions of this study the acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight.