Niobium sulfur tin zinc oxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions. Lack of data on analytical purity of the test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

yes

Remarks:

Lack of data on analytical purity of the test substance.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Lack of data on analytical purity of the test substance.

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

niobium oxygen sulfur zinc λ²-stannane

EC Number:

800-035-9

Cas Number:

1374645-21-2

Molecular formula:

Sn1.8Zn0.2Nb2O6.8S0.2 (Sn(2-x)Zn(x)Nb2O(7-y)S(y) with x/2 ≤ y, 0.02 ≤ x ≤ 0.22, 0.01 ≤ y ≤ 0.22)

IUPAC Name:

niobium oxygen sulfur zinc λ²-stannane

Details on test material:

- Name of test material (as cited in study report): Niobium Sulfur Tin Zinc Oxide, EX 1455
- Physical state: solid
- Appearance: powder with lumps
- Analytical purity: no data
- Lot No.: L1903
- Stability under test conditions: The test substance was expected to be stable under the test conditions.
- Storage condition of test material: at room temperature
- Solubility: insoluble

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories, Inc.
- Age at study initiation: 9 weeks
- Weight at study initiation: 167 - 172 g
- Fasting period before study: overnight before dosing, until 3 - 4 h after dosing
- Housing: The animals were housed individually in suspended stainless steel cages with mesh floor. Beneath the cages, litter paper was placed and changed at least three times per week.
- Diet: Harlan Teklad Global 16% Protein Rodent Diet® #2016, ad libitum (except during fasting period)
- Water: filtered tap water, ad libitum
- Acclimation period: 7 - 10 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 37 - 67
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40% (w/w)
- Amount of vehicle (if gavage): 0.052 - 0.6 mL (depending on initial body weight and achieved dose)

MAXIMUM DOSE VOLUME APPLIED: 0.6 mL

DOSAGE PREPARATION (if unusual): Calculation of the individual doses was depending on individual body weights of the animals and the density and concentration of the test mixture.

Doses:

175, 550 and 2000 mg/kg bw

No. of animals per sex per dose:

175 mg/kg bw: 1
550 mg/kg bw: 1
2000 mg/kg bw: 3

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Animals were observed during the first several hours post-dosing and at least once daily during the observation period for mortality, signs of gross toxicity and behavioural changes. Individual body weights were determined weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14 d observation period.

Gross pathology:

Necropsy revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: not classified
DPD: not classified