N,N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 April 2003 to 10 April 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

445-890-5

EC Name:

-

Cas Number:

201290-01-9

Molecular formula:

C14H37NO2Si3

IUPAC Name:

7-ethoxy-2,2,7-trimethyl-3-(trimethylsilyl)-8-oxa-3-aza-2,7-disiladecane

Test material form:

liquid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature in the dark
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: the test substance was used as supplied

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test material was used as supplied. The absorption of the test material was not determined.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., UK
- Age at study initiation: 12 - 20 weeks old
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually housed in suspended metal cages
- Diet: Certified Rabbit Diet, ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15/hour
- 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
- Concentration (if solution): the test item was used undissolved

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

Assessment of ocular damage/ irritation was made at 1 hour, 24, 48 and 72 hours post-instillation

Duration of post- treatment incubation (in vitro):

Not applicable

Number of animals or in vitro replicates:

Initially, a single rabbit was treated. After consideration of the ocular responses produced in it, two additional animals were treated.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: not applicable

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation in all treated eyes at the 24-hour observation period and in one treated eye at the 48-hour observation. Two of the treated eyes appeared normal at the 48-hour observation and the remaining treated eye appeared normal at the 72-hour observation.

Other effects:

No other effects were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the eye irritation study, conducted according to OECD TG 405 and in compliance with GLP, the test material, N,N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane, was reported to be a mild irritant, but it did not meet the criteria from classification according to GHS and Regulation (EC) No. 1272/2008.