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Diss Factsheets

Administrative data

Description of key information

Acute Oral Toxicity

One reliable acute toxicity study via the oral route of administration is available. After single dosing of 2000 mg/kg to rats, the LD50 was established as greater than 2000 mg/kg bw (Weisz, 2017). Based on this result, the test substance is considered not classified as an acute oral toxicant.

Acute toxicity via inhalation

No acute toxicity study via the inhalation route of exposure was available. Based on Column 2, Annex VIII, section 8.5 adaptation in the REACH Regulation, no acute inhalation toxicity study is to be performed as a key study via the oral route and the dermal route of exposure is available.

Acute dermal toxicity

No acute toxicity study via the dermal route of exposure was available. The study does not need to be conducted as the substance does not meet the criteria for classification as acute toxicant or STOT SE by oral route and no systemic effects have been observed in in vivo studies with dermal exposure.

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:
20 July 2017 - 14 November 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
30 May 2008
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
no
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Treibacher Industrie AG/17-4283
- Expiration date of the lot/batch: 23 June 2018
- Purity: 99.9%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled room temperature (15-25 ºC, below 70 RH%), in the dark
- Stability under test conditions: Analysis of stability, homogeneity and concentration of the test item under test conditions was not performed as part of this study.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: On the day of administration, the test item was freshly formulated at a concentration of 200 mg/mL in the vehicle.
- No correction for purity was made.

FORM AS APPLIED IN THE TEST (if different from that of starting material): formulation with 1% methylcellulose at a concentration of 200 mg/mL.
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, 12 weeks old
- Weight at study initiation: 218-280 g. Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: The night before treatment the animals were fasted for a maximum of 16 hours. Food, but not water, was withheld overnight. Food was replaced 3 hours after the treatment.
- Housing: Group caging (3 animals/cage) in type II. polypropylene/polycarbonate cages. “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): ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by Ssniff Spezialdiäten GmbH, D-59494 Soest Germany (batch number: 262 21592, expiry date: 31 January 2018), ad libitum
- Water (e.g. ad libitum): municipal tap water, ad libitum
- Acclimation period: 37-38 days before start of treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0-24.3ºC
- Humidity (%): 31-70%
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/ 12 hours light

IN-LIFE DATES
- From: 2017-07-20 To: 2017-08-03 (females no. 9846, 9847, 9848)
- From: 2017-07-21 To: 2017-07-04 (females no. 9849, 9850, 9851)

Route of administration:
oral: gavage
Vehicle:
methylcellulose
Remarks:
aqueous solution of methylcellulose at 1%
Details on oral exposure:
VEHICLE (1% methylcellulose)
- Concentration in vehicle: 200 mg/L
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: The selection of the vehicle was based on trial formulations with the test item. In order of preference, the recommended vehicles were the following: distilled water, 0.5 or 1% methylcellulose or carboxymethylcellulose, PEG 400, corn oil, sunflower oil or DMSO. Trial formulation with distilled water caused inhomogeneous formulation, therefore it was considered as not suitable for treatment. Consequently, 1% methylcellulose was also tried as a vehicle, which resulted in an acceptably stable formulation, suitable for treatment.
- Lot/batch no. (if required): 5115851 for methylcellulose; 8020117 for distilled water


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION (if unusual): Test item was freshly formulated on the day of administration. To limit the impact, the formulations were used within 4 hours after adding the vehicle to the test item and the test item preparation was performed with approved procedures and documented in detail. The formulation was homogenised to visually acceptable levels and was stirred up to finishing the treatment to ensure sufficient homogeneity.

- Rationale for the selection of the starting dose: The initial dose level was selected by the Study Director to be that which is most likely to produce mortality in some of the dosed animals. Based on the preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose. The limit dose (= starting dose level) for this study was 2000 mg/kg bw. Initially, three female animals were treated with 2000 mg/kg bw of the test item. No mortality was observed, therefore further 3 animals were treated at the dose level of 2000 mg/kg bw. As no mortality was observed in this second dose group, further testing was not required according to the test guidelines (OECD 423, Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris).


Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2 groups; 3 females/group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
* Clinical signs: Animals were observed individually after dosing at 30 minutes, then 1, 2, 3, 4 and 6 hours after the treatment and once each day in the morning for 14 consecutive days thereafter.
* 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.
* Body weight: 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, all animals were subjected to a necropsy and a macroscopic examination. The animals were exsanguinated after verification of narcosis following an injection of pentobarbital sodium (Release, 30% pentobarbital sodium; Lot number: 106075, Expiry date: 31 July 2018, Produced by: Wirtschaftsgenossenschaft deutscher Tierärzte eG, Germany). After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. All gross macroscopic changes were recorded for each animal.
Statistics:
No statistical analysis was performed.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Yttrium did not cause any mortality at a dose level of 2000 mg/kg bw.
Clinical signs:
other: Distended abdomen (6/6), slightly decreased activity (1/6) and irritability (1/6) were seen in the animals after treatment. However, all animals became symptom free from Day 1 or 2.
Gross pathology:
At necropsy, there was no evidence of macroscopic observations at a dose level of 2000 mg/kg bw.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the acute oral LD50 value of yttrium metal (powder form) was found to be above 2000 mg/kg bw in female Crl:WI rats. According to these results, yttrium metal needs not to be classified according to CLP criteria.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Acute toxicity - oral:

One reliable acute toxicity study via oral administration is available.

In the study, 6 female Wistar rats were dosed on a single occasion with the test substance in 1% methylcellulose at 2000 mg/kg bw (according to OECD guideline 423 and GLP; Weisz, 2017). During the subsequent 14-day observation period, no deaths were observed. Distended abdomen, slightly decreased activity, and irritability were seen in animals after treatment, but all were symptom free by Day 1 or 2. Body weight loss was observed in two animals during the observation period. The body weight of the remaining animals showed no indication of a test item-related effect. No evidence of macroscopic observations found at necropsy.

The LD50 was higher than 2000 mg/kg bw. Based on this result, the test substance is considered not classified as an acute oral toxicant.

Acute toxicity - inhalation:

No acute toxicity study via the inhalation route of exposure was available. Based on Column 2, Annex VIII, section 8.5 adaptation in the REACH Regulation, no acute inhalation toxicity study is to be performed as a key study via the oral route and the dermal route of exposure is available.

Acute toxicity - dermal:

No acute toxicity study via the dermal route of exposure was available. The study does not need to be conducted as the substance does not meet the criteria for classification as acute toxicant or STOT SE by oral route and no systemic effects have been observed in in vivo studies with dermal exposure.

Justification for classification or non-classification

Based on the results of the key acute oral toxicity study and according to the criteria of the CLP Regulation, yttrium metal is not to be classified as acute oral toxicant.

No data is available to conclude on classification for acute inhalation toxicity.

No data is available to conclude on classification for acute dermal toxicity. However, based on the acute oral LD50 being > 2000 mg/kg bw and based on the fact that no adverse effects have been observed in other studies involving dermal exposure (in vivo skin irritation/sensitisation studies by Bertl 2006 and Salvador 2015), the substance can be safely concluded not to be classified as acute dermal toxicant according to the CLP Regulation.