Yttrium chloride hexahydrate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03 November 2016 - 25 January 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 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Remarks:

Minor technical oversights not considered to have impacted the integrity of the study.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Remarks:

Minor technical oversights not considered to have impacted the integrity of the study.

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Remarks:

Minor technical oversights not considered to have impacted the integrity of the study.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Yttrium chloride hexahydrate

Cas Number:

10025-94-2

Molecular formula:

YCl3.6H2O

IUPAC Name:

Yttrium chloride hexahydrate

Test material form:

solid: particulate/powder

Details on test material:

- Name of the test material (as cited in the report): yttrium trichloride hexahydrate
- Physical state: solid
- Appearance: white to yellowish crystalline powder
- Further information on test material confidential.

Specific details on test material used for the study:

No correction for purity was applied during the test.

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Crl:(WI)

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: young healthy adult rats, 11-12 weeks old
- Weight at study initiation: 223 – 242 g. Body weight variation did not exceed +/-20% of the sex mean.
- Fasting period before study: 16 hours maximum, overnight
- Housing: Group caging (3 animals/cage), Type II. polypropylene/polycarbonate, “Lignocel 3/4-S Hygienic Animal Bedding” and “Arbocel crinklets natural” nest building material produced by J. Rettenmaier & Söhne GmbH & Co.KG (D-73494 Rosenberg, Germany) were available to animals during the study.
- Diet (e.g. ad libitum): sniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by Ssniff Spezialdiäten GmbH, D-59494 Soest Germany (278 5652, expiry date: 30 November 2016 and batch number: 141 8884, expiry date: 31 January 2017), ad libitum
- Water (e.g. ad libitum): municipal tap water, ad libitum
- Acclimation period: at least 28 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9 – 23.0 ºC
- Humidity (%): 27 - 71%
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: Trial formulations with the test item.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

Single dose, 2000 mg/kg bw

No. of animals per sex per dose:

6 females. Initially, three female animals were treated with 2000 mg/kg bw of the test item. Only 1 animal was found dead on Day 2, therefore a further 3 animals were treated at the dose level of 2000 mg/kg bw.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
*Clinical observations: 30 minutes, then 1, 2, 3, 4 and 6 hours after the treatment and once each day in the morning for 14 consecutive days. Individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
*The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0) and weekly thereafter.
- Necropsy of survivors performed: Yes. Macroscopic examination was performed on all animals. The surviving animals were sacrificed by exsanguination under pentobarbital anaesthesia (Euthanimal 40%). After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed.

Statistics:

No statistical analysis was performed (the method used is not intended to allow the calculation of a precise LD50 value).

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Two females were found dead on Day 1 and 2.

Clinical signs:

other: Decreased activity (slight/moderate), hunched back and piloerection were present in both of the found dead animals up to the point of death. The same symptoms were present in all surviving animals from the day of treatment up to Day 7, with brownish colou

Gross pathology:

Found dead animals: In the stomach, diffuse grey/green discoloration of the glandular mucosa, diffuse thickness of the glandular mucosa, clear liquid mixed with digestive contents/diets and dilatation were considered to be test item-related. The changes of the lungs, thymus and urinary bladder were regarded as agonal/post mortem or incidental.
Surviving animals: Red foci of the stomach glandular mucosa seen in 2/4 surviving animals terminated on Day 14, were regarded as test item-related.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

Under the conditions of this study, the acute oral LD50 value of the test item yttrium trichloride hexahydrate was found to be equal to or above 2000 mg/kg bw in female Crl:WI Wistar rats.
According to the GHS criteria, classification of yttrium trichloride hexahydrate in "Category 5" for acute oral toxicity is appropriate. Under the CLP Regulation, no classification is required.