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EC number: 300-346-5 | CAS number: 93925-43-0
Toxicological information
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 Nov - 01 Dec 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted Feb 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- May 2008
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- Aug 1998
- 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:
- standard acute method
- Limit test:
- yes
Test material
- 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
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: 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 the vehicle and test substance. In order to obtain homogeneity, the test substance formulation was heated in a water bath with a maximum temperature of 81.1 °C for a maximum of 1 hour and 37 minutes. The test substance formulation was allowed to cool down to a temperature of maximally 40 °C prior to dosing.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI (Han) (outbred, SPF-Quality)
- 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
- Weight at study initiation: 290 ± 13 g (males); 197 ± 11 g (females);
- Housing: individually housed in labeled Makrolon cages (MIII 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: 19.6 – 21.9)
- Humidity (%): 40 - 70 (actual range: 40 - 56)
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: hydrogenated corn oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: approximately 25 cm² for males; approximately 18 cm² for females
- % coverage: 10
- Type of wrap if used: a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed with tap water
- Time after start of exposure: 24 h
TEST MATERIAL
- Concentration: 10 mL/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- 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 mortality and morbidity; individual body weights were determined on days 1 (pre-administration), 8, 15 and prior to sacrifice; clinical signs were determined at periodic intervals on the day of dosing (Day 1) and once daily thereafter until Day 15
- Necropsy of survivors performed: yes
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:
- One female was sacrificed for ethical reasons on Day 8 due to an excessive weight loss.
- Clinical signs:
- other: Lethargy was noted in 1/5 males on Day 2 and in 4/5 males on Day 1, and recurred in 2/5 males on Day 8. In females lethargy was observed in 3/5 females on Day 1, in 2/5 females on Days 7 or 8. Flat posture was observed in 1/5 males on Day 1. Hunched postu
- Gross pathology:
- The female that was sacrificed for ethical reasons on Day 8 showed a reduced size of the thymus at macroscopic post mortem examination. No abnormalities were observed at macroscopic post mortem examination in the 9 surviving animals.
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 | |||||||||||||||
Males |
||||||||||||||||||
| Animal 1 | ||||||||||||||||||
| Lethargy | (3) | - | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| Hunched posture | (1) | - | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| Flat posture | (1) | - | - | - | 1 | 1 | 1 | 1 | 1 | - | 1 | 1 | 1 | - | - | - | - | - |
| Piloerection | (1) | - | - | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - |
| Chromodacryorrhoea (snout) | (3) | - | - | - | 2 | 1 | - | - | - | - | - | - | - | - | - | - | - | - |
| ptosis | (3) | - | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| Animal 2 | ||||||||||||||||||
| Lethargy | (3) | - | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| Hunched posture | (1) | - | - | - | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - |
| Piloerection | (1) | - | - | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - |
| Chromodacryorrhoea (snout) | (3) | - | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - |
| ptosis | (3) | - | - | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| Animal 3 | ||||||||||||||||||
| Lethargy | (3) | - | - | - | 2 | - | - | - | - | - | - | - | - | - | - | - | - | - |
| Hunched posture | (1) | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - | - |
| Piloerection | (1) | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | 1 | - | - | - | - | - | - | - |
| Chromodacryorrhoea (snout) | (3) | - | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - |
| ptosis | (3) | - | - | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - |
| Animal 4 | ||||||||||||||||||
| Lethargy | (3) | - | 1 | 1 | - | - | - | - | - | - | 1 | - | - | - | - | - | - | - |
| Hunched posture | (3) | - | - | - | 1 | 1 | 1 | 1 | 1 | - | 1 | 1 | 1 | - | - | - | - | - |
| Piloerection | (1) | - | - | 1 | 1 | 1 | - | - | - | - | 1 | 1 | - | - | - | - | - | - |
| Scales | (3) | - | - | - | - | - | - | - | 1 | 1 | 1 | - | - | - | - | - | - | - |
| Chromodacryorrhoea (snout) | (3) | - | 1 | 1 | 1 | - | - | - | - | - | 1 | - | - | - | - | - | - | - |
| ptosis | (3) | - | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| Animal 5 | ||||||||||||||||||
| Lethargy | (3) | - | 1 | 1 | 2 | - | - | - | - | - | 1 | - | - | - | - | - | - | - |
| Hunched posture | (1) | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - |
| Shallow respiration | (3) | - | - | - | - | - | - | - | - | - | 1 | - | - | - | - | - | - | - |
| Piloerection | (3) | - | 1 | 1 | 1 | 1 | - | - | - | - | 1 | 1 | - | - | - | - | - | - |
| Chromodacryorrhoea (snout) | (3) | - | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - |
| lean | (1) | - | - | - | - | - | - | - | - | - | 1 | - | - | - | - | - | - | - |
| ptosis | (3) | - | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - |
Females |
||||||||||||||||||
| Animal 6 | ||||||||||||||||||
| Lethargy | (3) | - | 1 | 1 | - | - | - | - | - | - | 1 | - | - | - | - | - | - | - |
| Hunched posture | (1) | - | - | - | 1 | 1 | 1 | 1 | 1 | - | 1 | 1 | 1 | 1 | - | - | - | - |
| Piloerection | (3) | - | 1 | 1 | 1 | 1 | - | - | - | - | 1 | 1 | - | - | - | - | - | - |
| Chromodacryorrhoea (snout) | (3) | - | 1 | 2 | 2 | - | - | - | - | - | - | - | - | - | - | - | - | - |
| ptosis | (3) | - | 1 | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| Animal 7 | ||||||||||||||||||
| Restless | (3) | - | - | - | - | - | - | - | - | 1 | - | |||||||
| Lethargy | (3) | - | - | 1 | - | - | - | - | - | - | 1 | |||||||
| Hunched posture | (1) | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |||||||
| Shallow respiration | (3) | - | - | - | 2 | - | - | - | - | - | 1 | |||||||
| Piloerection | (1) | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |||||||
| Chromodacryorrhoea (snout) | (3) | - | - | - | 2 | - | - | - | - | 1 | 1 | |||||||
| lean | (1) | - | - | - | - | - | - | - | - | - | 1 | |||||||
| ptosis | (3) | - | - | - | - | - | - | - | - | - | 1 | |||||||
| Animal 8 | ||||||||||||||||||
| Lethargy | (3) | - | - | 1 | - | - | - | - | - | - | - | - | - | - | - | - | - | - |
| Hunched posture | (1) | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - |
| Piloerection | (1) | - | - | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - |
| Chromodacryorrhoea (snout) | (3) | - | 1 | 1 | 2 | - | - | - | - | - | - | - | - | - | - | - | - | - |
| Animal 9 | ||||||||||||||||||
| Hunched posture | (1) | - | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - |
| Piloerection | (1) | - | - | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - | - | - | - | - | - |
| Chromodacryorrhoea (snout) | (3) | - | - | - | 2 | - | - | - | - | - | - | - | - | - | - | - | - | - |
| Animal 10 | ||||||||||||||||||
| Lethargy | (3) | - | - | - | - | - | - | - | - | - | 1 | - | - | - | - | - | - | - |
| Hunched posture | (1) | - | - | - | 1 | - | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - |
| Piloerection | (1) | - | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | - | - | - | - |
| Chromodacryorrhoea (snout) | (3) | - | - | - | 2 | - | - | - | - | - | 1 | - | - | - | - | - | - | - |
| lean | (1) | - | - | - | - | - | - | - | - | - | 1 | - | - | - | - | - | - | - |
Number in brackets = Max score
Table 2 Body weights (gram)
| Days | 1 | 8 | 15 |
| Males | |||
| Animal 1 | 284 | 274 | 313 |
| Animal 2 | 309 | 306 | 347 |
| Animal 3 | 288 | 271 | 309 |
| Animal 4 | 274 | 265 | 298 |
| Animal 5 | 296 | 268 | 311 |
| Mean ± SD | 290 ± 13 | 277 ± 17 | 316 ± 18 |
| Females | |||
| Animal 1 | 199 | 187 | 206 |
| Animal 2 | 189 | 142 | - |
| Animal 3 | 188 | 197 | 208 |
| Animal 4 | 194 | 191 | 205 |
| Animal 5 | 214 | 196 | 226 |
| Mean ± SD | 197 ± 11 | 183 ± 23 | 211 ± 10 |
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
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