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Toxicological information

Eye irritation

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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:
2012
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

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

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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