Tin titanium zinc oxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

other: Japan MAFF Testing Guideline of 12 Nosan No. 8147

Deviations:

no

GLP compliance:

yes

Remarks:

Austrian Research Centers GmbH - ARC

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

485-430-0

EC Name:

-

Cas Number:

923954-49-8

Molecular formula:

SnxZnyTi2Oz with x = 0,5 – 1,7 y = 0,5 – 1,7 z = 5,5 – 7,5

IUPAC Name:

oxygen titanium zinc λ²-stannane

Details on test material:

- BASF-Test substance No.: 07/0285-1
- Physical state: Orange solid
- Analytical purity: > 95 %
- Expiration date of substance: 29 May 2009
- Stability under test conditions: the stability of the test substance under storage conditions over the test period was guaranteed by the manufacturer
- Storage condition of test material: ambient temperature

Test animals

Species:

rat

Strain:

other: Crl:(WI)BR

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld.
- Age at study initiation: ca. 8 weeks
- Weight at study initiation: mean 181.7 g
- Fasting period before study: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
- Housing: Single caging in Makrolon cages type III (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids. Sanitation of cages once a week.
- Diet (e.g. ad libitum): Ssniff R/M-H maintenance diet for rats and mice (item V1534-3 ) ad libitum, supplied by Ssniff Spezialdiäten GmbH, 59494 Soest, Germany
- Water (e.g. ad libitum): Tap water from an automatic watering system, ad libitum.
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 22.1
- Humidity (%): average of 60.3
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: The test substance was not soluble in water. Aqueous CMC ist a common vehicle for acute oral toxicity testing.
- Lot/batch no. (if required): 0.5 % aqueous solution of Na-carboxymethylcellulose ("CMC" high viscosity, item No. C-5013, Lot. No. 98H0328, Sigma)

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: by request of the sponsor

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations at least once per day, body weights before administration, 7 and 14 days after the administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

other: General findings: No toxic effects were noted during the entire observation period. An orange discolouration of the faeces was observed in all animals 1 d p.a. This finding is not considered to be a toxic effect.

Gross pathology:

All animals were normal at the necropsy 14 d.

Any other information on results incl. tables

Body weights:

	Body weight (g)			Body weight gain (g)
Animal	before admininstration	7 d	14 d	d 0-7	d 7-14
1	174	215	231	41	16
2	183	212	226	29	14
3	188	224	234	36	10

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met