Registration Dossier
Registration Dossier
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EC number: 300-346-5 | CAS number: 93925-43-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 - 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:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted Oct 2012
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- Aug 1998
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- May 2008
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification 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 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
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 26 - 29 weeks
- Weight at study initiation: 3.52 - 3.61 kg
- Housing: Individually housed in labeled cages with perforated floors and shelters
- Diet: Global Diet 2030, pelleted diet for rabbity [Harlan Teklad, Milan, Italy], approximately 100 g per days; hay and wooden sticks
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.0 - 21.2
- Humidity (%): 43.0 - 77.0
- Air changes (per hr): Approximately 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- Reading time points: 1, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye remained unwashed following the instillation
SCORING SYSTEM: Draize scoring system
TOOL USED TO ASSESS SCORE: 24 h after instillation of the test substance, a 2% fluorescein solution was instilled into both eyes of each animal to quantatively determine the corneal epithelial damage
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- Slight conjunctivae (score 1) was observed in 3/3 animals at the 1-h reading time point; persisting until the 24-h reading time point. The conjunctivae had cleared in all animals within 48 h. The scores for chemosis were 0 at all the reading time points in all animals. No effects on the iris and cornea were noted in any rabbit at any time point.
- Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.
Any other information on results incl. tables
Table 1: Individual eye irritation scores
| Rabbit # | Time [h] | Conjunctivae | Iris (0-2) | Corneal opacity (0-4) | |
| Redness (0-3) | Chemosis (0-4) | ||||
| 1 | 1 | 1 | 0 | 0 | 0 |
| 24 | 1 | 0 | 0 | 0 | |
| 48 | 0 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
| 2 | 1 | 1 | 0 | 0 | 0 |
| 24 | 1 | 0 | 0 | 0 | |
| 48 | 0 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
| 3 | 1 | 1 | 0 | 0 | 0 |
| 24 | 1 | 0 | 0 | 0 | |
| 48 | 0 | 0 | 0 | 0 | |
| 72 | 0 | 0 | 0 | 0 | |
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
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