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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
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:
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

Constituent 1
Chemical structure
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:
Tin Titanium Zinc kegginite B
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- Fasting period before study: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.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:
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

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