3-chloropropyltrimethoxysilane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993/05/03-1993/05/07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test animals / tissue source

Species:

rabbit

Strain:

other: Small white ChBB:HM, SPF

Details on test animals or tissues and environmental conditions:

TEST ANIMALS

- Source: Dr. Karl Thomae GmbH, Chemisch-Pharmazeutische Fabrik, 88400 Biberach an der Riss 1.

- Weight at study initiation: 2.3-2.6 kg

- Housing: Animals were individually caged in stainless steel cages.

- Diet: Ssniff K 4 Comprehensive Rabbit Chow (ad libitum) Ssniff Specialfoods GmbH, 59494 Soest.

- Water: ad libitum

- Acclimation period: Minimum of 14 days


ENVIRONMENTAL CONDITIONS

- Temperature (°C): 20 ± 3°C

- Humidity (%): 30-70

- Air changes (per hr): 15

- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the other eye of each animal served as a control.

Amount / concentration applied:

TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1 cm3 of the liquid test material was applied in the conjunctival sac of the right eye of each animal

Duration of treatment / exposure:

72 hour(s)

Observation period (in vivo):

24, 48, and 72 hours

Number of animals or in vitro replicates:

3

Details on study design:

- Washing (if done): Washing was carried out with a sodium chloride solution of body temperature.

-Time after exposure: 24 hours


SCORING SYSTEM: Draize 1959.


TOOL USED TO ASSESS SCORE: 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:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

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:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #1

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

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

A single instillation to the rabbit eye produced minimal conjunctival irritation in the three animals at one hour post exposure. The adverse effect was completely reversed by 48 hours.

Other effects:

No other effects reported.

Any other information on results incl. tables

Table 1: Irritant response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	1/0/0	1/1/1	1/1/1
24 h	0/0/0	0/0/0	1/0/0	0/0/0
48 h	0/0/0	0/0/0	0/0/0	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Reversibility*)	-	c	c	c
Average time (unit) for reversion		24h	24h	24h

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the eye irritation study, conducted according with OECD Test Guideline 405 and in compliance with GLP, (3-chloropropyl)trimethoxysilane was found to be non-irritant to rabbit eyes.