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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:
27 October 2011 to 14 November 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:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(2008)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
(1998)
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): (Chloromethyl)triethoxysilane
- Physical state: colourless liquid
- pH value: 5-6
- Densitiy: 1.03 g/ml (at 20 °C, 1013 hPa)
- Lot/batch No.: KH09731
- Expiration date of the lot/batch: 11 July 2013
- Storage condition of test material: at room temperature (20±5 °C), protected from light

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 GmbH, Stolzenseeweg 32-36, 88353 Kisslegg, Germany
- Age at study initiation: 12 weeks
- Weight at study initiation: 2608.6–2795.9 g
- Housing: individually in stainless steel cages equipped with feed hoppers and drinking water bowls
- Diet: Pelleted standard Teklad Global High Fiber Rabbit Diet 2031C (batch no. 35/11, Provimi Kliba AG, 4303 Kaiseraugst, Switzerland), ad libitum. A piece of wood (batch no. 122201, imported by Indulab AG, Gams, Switzerland from ABEDD® - LAB & VET GmbH, 1160 Vienna, Austria) and a haystick 4642 (batch no. 06/11, Provimi Kliba AG, 4303 Kaiseraugst, Switzerland) were also provided for environmental enrichment.
- Water: Community tap water from Füllinsdorf, ad libitum
- Acclimation period: Under laboratory conditions after health examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
- Other: Music played during the daytime light period.

IN-LIFE DATES: From 11 November 2011 to 14 November 2011

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and was used for control purposes.
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml
Duration of treatment / exposure:
single application in to the left eye
Observation period (in vivo):
Approximately 1 hour and 24, 48 and 72 hours following treatment
Number of animals or in vitro replicates:
3 animals were tested in total. (After consideration of the ocular responses produced in the first treated animal, two additional animals were treated. )
Details on study design:
SCORING SYSTEM: Draize scoring system and according to Regulation (EC) 440-2008

TOOL USED TO ASSESS SCORE: hand-slit lamp (Varta Cliptrix diagnostic-lamp, Roth AG, 4153 Reinach, Switzerland)

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:
conjunctivae score
Basis:
mean
Remarks:
over animals #1 and #2
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: The maximum conjunctivae score for this animal was 1 at 1 and 24 h post treatment.
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
Irritant / corrosive response data:
No abnormal findings were observed in the cornea or for the iris light reflex of any animals at any of the measurement intervals. Slight redness of the conjunctivae was noted in one animal (no.3) at 1 and 24 hours after treatment. Thereafter, all animals were negative.The mean score was calculated separately for each animal across three scoring times (24, 48, and 72 hours after instillation) for corneal opacity, iris light reflex, redness and chemosis of the conjunctivae, respectively. The individual mean scores for corneal opacity and iris light reflex were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00 in two animals and 0.33 in one animal for reddening and all 0.00 for chemosis.
Other effects:
Viability/Mortality: No intercurrent deaths occurred during the course of the study.
Clinical signs: No clinical signs were recorded throughout the entire observation period.
Body weights: The body weights were within the range commonly recorded for this strain and age.

Any other information on results incl. tables

see attachments

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 its eye irritating properties according to the OECD TG 405, and in compliance with GLP. No abnormal findings were observed in the cornea or for the iris light reflex of any animals at any of the measurement intervals. Slight redness of the conjunctivae was noted in one animal at 1 and 24 hours after treatment. Thereafter, all animals were negative. No deaths occured, no signs of systemic toxicity were repoted, and the body weight was not affected by the treatment. Hence, classificaion for skin irritation according to EC/1272/2008 is not warranted.