Registration Dossier
Registration Dossier
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EC number: 269-105-9 | CAS number: 68187-54-2 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77865.
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-02-29 to 2000-03-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 1996-03-22
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Tin antimony grey cassiterite
- EC Number:
- 269-105-9
- EC Name:
- Tin antimony grey cassiterite
- Cas Number:
- 68187-54-2
- Molecular formula:
- Sn(2-x-y)Sb(x)V(y)O4 0,04≤x≤0,50 0≤y≤0,10
- IUPAC Name:
- Tin antimony cassiterite
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: Tin-Antimony-Grey
- Substance type: inorganic pigment
- Physical state: solid, grey powder
- Stability under test conditions: at least 96 hours
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 10 weeks old
- Weight at study initiation: males: 340 - 425 g; females: 208 - 225 g
- Fasting period before study: food was withheld overnight (for a maximum of 20 hours) prior to dosing until approximately 3 - 4 hours after administration of the test substance
- Housing: group housing of 3 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material (SAWI, Jelu Werk, Rosenberg,Germany).
- Diet (ad libitum): standard pelleted laboratory animal diet (from Cerfil Quality BVBA, Oud-Turnhout, Belgium)
- Water (ad libitum): tap-water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C
- Relative humidity: 30 - 70%
- Air changes: approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: vehicle was selected based on a pretest performed
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSAGE PREPARATION:
The formulation (w/w) was prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of vehicle (specific gravity 1.036). - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males / 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing: mortality/viability was recorded twice daily; body weights were recorded on days 1 (pre-administration), 8 and 15; clinical signs at periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15
- Necropsy of survivors performed: yes, at the end of the observation period - Statistics:
- No statistical analysis was performed.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: - females: hunched posture, uncoordinated movements and/or piloerection - males: lethargy and/or uncoordinated movements The animals had recovered from the symptoms between days 2 and 4.
- Gross pathology:
- No abnormalites were found at macroscopic post mortem examination of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (male and female rats) > 2000 mg/kg bw
According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not acutely toxic via the oral route.
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