Morpholine, 4-[(triethoxysilyl)methyl]-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2005-05-16 until 2005-06-09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD test under GLP.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

480-370-1

EC Name:

-

Cas Number:

21743-27-1

Molecular formula:

Hill formula: C11H25NO4Si CAS formula: C11H25NO4Si

IUPAC Name:

4-[(triethoxysilyl)methyl]morpholine

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, D-88353 Kisslegg
- Weight at study initiation: 2.1- 2.5 kg
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3 °C
- Humidity (%): 55 +/- 10 % rel. humidity
- Air changes (per hr): at least 10/h
- Photoperiod (hrs dark / hrs light): 12hdark, 12 h light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:

The substance was not washed out.

Observation period (in vivo):

one animal: 72 h
two animals: 168 h

Number of animals or in vitro replicates:

3 females

Details on study design:

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

SCORING SYSTEM: as stated in Guideline OECD 405


TOOL USED TO ASSESS SCORE: not given in the report except fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: no effects observed

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: no effects observed

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

other: no effects oberved

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: no effects observed

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: no effects observed

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

other: no effects observed

Results 7

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

3

Reversibility:

fully reversible within: 144 h

Results 9

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

3

Reversibility:

fully reversible within: 72 h

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 168 h

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 168 h

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 7 days.

Other effects:

No corneal lesions were found upon fluorescein examination at the final reading. No clinical effects were observed. Throughout the 72 h observation period no significant weight loss was recorded in the test animals.

Any other information on results incl. tables

Comments:

Maximum duration of any effect (in hours):

conjunct./redness: > 72

conjunct./chemosis: > 72

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The substance has produced only slight irritation and therefore has not to be classified as irritant according to the EU regulations.

Executive summary:

An acute eye Irritation/Corrosion test according to OECD 405 was performed. The test item was applied to the lower conjunctival sac of one eye of 3 female New Zealand White Rabbits Crl:KBL (NZW) at a dose of 0.1 ml per application site. The untreated eye served as control. The test item showed slight irritant effects on the conjunctivae of all 3 animals (redness mean score 0.67 - 1.33; chemosis mean score 0.33 - 1). All changes were fully versible within 7 days.

The test item produced no corrosion and no corneal lesions were found upon fluorescein examination at the final reading in any of the animals. No other treatment related effects were observed. Throughout the 72 h observation period no significant weight loss was recorded. Therefore, the substance does not have to be classified and has no obligatory labelling requirement for eye irritation.