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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:
22 October 1991 to 01 November 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Wacker Silan I0-Trimethoxy, IO-Trimethoxy, Iso-octyltrimethoxysilan
- Molecular formula: C11H26O3Si
- Molecular weight: 234 g/mol
- Substance type: Alkoxysilane
- Physical state: colourless liquid
- Melting point: <-20 °C
- Boiling point: approx. 90 °C at 1013 hPa
- Density: 0.9kg/l at 25 °C
- Solubility in water: < 1 g/l
- Date of delivery: 24 September 1991
_storage conditions: at room temperature, protected from light in a chemicla hood
- Stability under storage conditions: Stable until 01 Feb 1992
- Lot/batch No.: 0356KE

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventionell bred
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.1-3.3 kg
- Housing: in individual cages (battery housing)
- Diet: Altromin 2123 Haltungsdiät - Kanninchen (Altromin GmbH, Lage/Lippe, Germany), ad libitum; and 15 g hay daily
- Water: deionised and chlorised water, ad libitum, provided in automated drinking troughs

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3
- Humidity (%): 55±20
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 22 October 1991 to: 01 November 1991

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
24 h
Observation period (in vivo):
reading time pointr: 1, 24, 48, and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with physiol. NaCl solution at 37 °C
- Time after start of exposure: after 24 h and at every reading time point, when dicharge was observed or the eyes were determined for corneal damage using fluorescein

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
over all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
over all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
over all 3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
One hour after exposure the conjunctivae had diffuse redness and partial eversion of the eyelids. After 24 hours two animals had marked hyperaemia. After 48 hours the irritation had reversed.
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008
Conclusions:
The test item was tested for eye irritation according to the OECD TG 405 and in compliance with GLP. One hour after exposure the conjunctivae had diffuse redness and partial eversion of the eyelids. After 24 hours two animals had marked hyperaemia (grade 2). One animal fully recovered within 24 h, the other two animals fully recovered within 48 h. Based on these findings classification according to 67/584/EEC and EC/1272/2008 is not warranted.