(chloromethyl)diethoxymethylsilane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

See endpoint summary for justification of read-across.

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

27 October 2011 to 14 November 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

(2002)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(2008)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Version / remarks:

(1998)

Deviations:

no

GLP compliance:

yes

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

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)

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 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.

see attachments

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

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 67/584/EEC and EC/1272/2008 is not warranted.

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

(chloromethyl)diethoxymethylsilane

EC Number:

218-657-9

EC Name:

(chloromethyl)diethoxymethylsilane

Cas Number:

2212-10-4

Molecular formula:

C6H15ClO2Si

IUPAC Name:

(2-chloro-1,1-diethoxyethyl)silane

Test material form:

liquid

Details on test material:

Purity approx. 99% (GC)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Reversibility:

other: reversibility: not applicable

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks:

animal #3

Remarks on result:

other: The maximum conjunctivae score for this animal was 1 1 and 24 h post treatment.

Remarks:

animal #3

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable