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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 - 27 Oct 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted Feb 2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Version / remarks:
May 2008
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Version / remarks:
2002
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, No 8147
Version / remarks:
Nov 2000
Deviations:
not specified
GLP compliance:
yes (incl. QA statement)
Remarks:
Food and Consumer Product Safety Authority (VWA), Utrecht, The Netherlands
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane
EC Number:
300-346-5
EC Name:
Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane
Cas Number:
93925-43-0
Molecular formula:
C4H8O2, C20H44O4SiSn, C24H52O6SiSn, C40H84O8SiSn2, C60H128O12Si2Sn3, C80H172O16Si3Sn4, C100H216O20Si4Sn5
IUPAC Name:
Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The formulations (w/w) were prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle and test substance. In order to obtain homogeneity, the test substance formulations were heated in a water bath with a maximum temperature of 79.1ºC for a maximum of 40 minutes. The test substance formulations were allowed to cool down to a temperature of maximally 40ºC prior to dosing.

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl:WI (Han) (outbred, SPF-Quality)
Sex:
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: 11 weeks
- Weight at study initiation: group 1: 171 ± 22 g; group 2: 183 ± 10 g
- Fasting period before study: animals were fasted overnight prior to administration of the test substance
- Housing: group housing of 3 animals per cage in labeled Makrolon cages (MIV type; height 18 cm.) containing sterilized sawdust as bedding material and paper as cage enrichment.
- Diet: SM R/M-Z, pelleted, (Ssniff Spezialdiäten GmbH, Soest, Germany),ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 (actual range: 19.3 – 21.2)
- Humidity (%): 40 - 70 (actual range 44 - 73)
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: dehydrated corn oil
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 females (3 females dosed per step in 2 steps)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed twice daily for mortaility; individual body weights were determined on days 1 (pre-administration), 8, 15 and prior to sacrifice.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the study period.
Clinical signs:
other: Hunched posture was observed in 6/6 animals on Day 1-2, and recurred in 6/6 animals on Day 5 or 7, persisting until Day 11 in 5/6 and until Day 14 in 1/6. Piloerection was noted in 3/6 animals on several or all days in the period from Day 7-11. A lean ap
Gross pathology:
No substance-related findings.

Any other information on results incl. tables

Table 1 Clinical signs

Test Days 1 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Hours after dosing 0 2 4                            
Animal 1                                  
Hunched posture - 1 1 - - - - - 1 1 1 1 1 - - - -
Animal 2                                  
Hunched posture - 1 1 - - - - - - - 1 1 1 - - - -
Animal 3                                  
Hunched posture - 1 1 1 - - - - - - 1 1 1 - - - -
Animal 4                                  
Hunched posture 1 1 1 1 - - 1 1 1 1 1 1 1 1 1 1 -
Piloerection - - 1 - - - - - 1 1 1 1 1 - - - -
Lean - - - - - - - - - 1 1 1 1 1 1 1 -
Animal 5                                  
Hunched posture 1 1 1 1 - - - - 1 1 1 1 1 - - - -
Piloerection - - - - - - - - 1 1 - - 1 - - - -
Animal 6                                  
Hunched posture 1 1 1 1 - - 1 1 1 1 1 1 1 - - - -
Piloerection - - - - - - 1 1 1 1 - - - - - - -
Lean - - - - - - - - - 1 1 1 1 - - - -

1 = Max Grade of clinical signs

Table 2 Body weights (gram)

Days 1 8 15
Animal 1 146 146 175
Animal 2 188 200 215
Animal 3 178 197 203
Mean ± SD 171 ± 22 181 ± 30 198 ± 21
Animal 4 181 151 170
Animal 5 194 201 216
Animal 6 174 158 201
Mean ± SD 183 ± 10 170 ± 27 196 ± 23

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified