Methyl-tris acetonoximo-silane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-07-20 to 2012-09-24

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 guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 24 April 2002

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-propanone, 2,2’,2”-[O,O’,O”-(ethylsilylidyne)trioxime]

EC Number:

611-631-1

Cas Number:

58190-57-1

IUPAC Name:

2-propanone, 2,2’,2”-[O,O’,O”-(ethylsilylidyne)trioxime]

Specific details on test material used for the study:

- Product Name: EAC3
- CAS number: 58190-57-1
- Batch number: 1000061820
- Appearance: yellowish, liquid
- Manufacture date: 11 January 2010
- Expiry date: 11 January 2013
- Storage conditions: Controlled Room Temperature (15-25 °C, below 70 RH%), Protected from humidity

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: S&K-LAP Kft., 2173 Kartal, Császár út 135, Hungary
- Age at study initiation: 13 weeks old (adult)
- Weight at study initiation: 3294 – 3525 g
- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages.
- Diet (e.g. ad libitum): Yes, UNI diet (Batch No.: 0070 05 12 / 0090 05 12 / 0100 06 12 , Expiry date: 02 August 2012 / 23 August 2012 / 25 September 2012) for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi út, Hungary
- Water (e.g. ad libitum): Yes, municipal tap water
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 49 – 89
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

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):

1, 24, 48 and 72 h after application

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

Application of the Test Item:
Three male animnals in acceptable health condition were selected for the test. First, an initial test was performed using one animal. The test item was instilled into the conjunctival sac of the left eye. The eyelids were held closed for a few seconds to prevent the loss of the test item. The contralateral eye served as the control. Immediately after the administration of the test item, an assessment of the initial pain reaction was made. After consideration of the ocular responses produced in the first animal, two additional animals were treated.

Clinical Observations:
The eyes were examined at 1, 24, 48 and 72 hours after treatment. The duration of the observation period was suuficient to identify reversibility or irreversibility of changes. Any clinical signs of toxicity of signs of ill-health during the study were recorded. At the end of the observation period, each animal was sacrificied by intramuscular injectiona of CP-Ketamin 10% and CP-Xylazin 2% followed by iv. Euthasol 40% anaesthesia. Death was verified by checking pupil and corneal reflex and the absence of respiration.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24 April 2002)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

iris score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of three animals

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The eyes were examined 1, 24, 48 and 72 hours after the application.
One hour after the application: Conjunctival redness (score 1 or 2), conjunctival chemosis (score 1 or 2) and conjunctival discharge (score 2 or 3) were found in all animals.
24 hours after the application: Conjunctival redness (score 1) was found in all animals. In addition, conjunctival discharge (score 1) was noted in one animal.
48 and 72 hours after the application: No signs of eye irritation or other clinical signs were noted.
As all signs of eye irritation had fully reversed, the study was terminated after a period of 72 hours observation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute eye irritation/corrosion study conducted according to OECD 405, the test item is considered to be non-irritant.

Executive summary:

In a primary eye irritation study (OECD 405), 0.1 mL of the test item was instilled into the conjunctival sac of one eye of each of three male New Zealand White rabbits. The untreated eye served as control. Control and treated animals were observed at 1, 24, 48 and 72 hours after application. Irritation was scored by the method of Draize. Only very mild conjunctival reactions were noted, which were fully reversible within 48 hours. Based on the results, the test item can be considered as not irritating.