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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:
18 Feb - 23 Feb 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
(1998)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Bayerisches Landesamt fuer Arbeitsschutz, Arbeitsmedizin und Sicherheitstechnik, Munich, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diethoxymethylsilane, SEMICOSIL M2E, Silane, diethoxymethyl-
- Physical state: colourless liquid
- Lot/batch No.: LC 11/05 Pos.2
- Expiration date of the lot/batch: 12 January, 2008
- Storage condition of test material: at room temperature, protected from light and humidity

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen
- Weight at study initiation: animal #1: 3.2 kg, #2: 3.3 kg, #3: 3.4 kg
- Housing: in ABS-Plastic rabbit cages, floor 4200 cm²
- Diet: Altromin 2123 maintenance diet for rabbit, rich in crude fibre, totally pathogen free (TPF), ad libitum
- Water: tap water (drinking water, municipal residue control, microbiol. controlled periodically), ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18±3°C
- Humidity (%): 55±10 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
reading time points: 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3 females
Details on study design:
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 three 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 three animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
over all three animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of animals #1 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
Animal No. 1 and 3 showed redness grade 1 of the conjunctivae 1 hour post instillation. 24 hours post instillation until the end of the observation period no signs of irritation were recorded.
Animal No. 2 showed redness grade 1 of the conjunctivae 1 hour, as well as 24 hours post instillation. 48 hours, as well as 72 hours post instillation no signs of irritation were recorded.
Other effects:
Throughout the observation period not weight loss was observed for the test animals.

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:
In conclusion, under the conditions chosen for the present study (according to OECD 405 and GLP) the test substance did not show eye irritating potential. Only one animal showed a slight redness of the conjunctivae which was fully reversed after 48 hours. Therefore, the test substance does not need to be classified for eye irritation.