N-[3-(trimethoxysilyl)propyl]butylamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 Nov - 20 Dec 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study conducted according to the appropriate OECD test guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1987)

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-methyl-3-(trimethoxysilyl)propylamine

EC Number:

221-334-5

EC Name:

N-methyl-3-(trimethoxysilyl)propylamine

Cas Number:

3069-25-8

IUPAC Name:

N-Methyl-3-(trimethoxysilyl)-1-propanamine

Test animals / tissue source

Species:

rabbit

Strain:

other: White Russian (Chbb)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. Carl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2200 g
- Housing: Animal was housed individually in a stainless steel cage
- Diet: K4 diet for rabbits (Ssniff Spezialfutter GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 ml

Duration of treatment / exposure:

24 h

Observation period (in vivo):

21 days
Reading time points: 1, 24, 48 and 72 h and 6, 8, 10, 13, 17 and 21 days

Number of animals or in vitro replicates:

1 male

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye was washed with warm physiological NaCl solution after the exposure period with the test material.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: eye lamp / fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: cornea opacity (grade 2) persisted after 21 days

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not reversible

Remarks on result:

other: iridial effects (grade 1) persisted after 21 days (circumcorneal injection from day 6 until study termination)

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks on result:

other: redness (grade 2) persisted after 21 days, necrotic conjunctival sac and haw observed after 24 h

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: chemosis (grade 1) persisted after 21 days

Irritant / corrosive response data:

Cornea opacity (grade 3) was observed immediately (1 h) after exposure with the test material and was slightly reverted within 24 h (grade 2). Nevertheless, corneal opacity persisted until study termination after 21 days (grade 2). Iridial effects (grade 1) were also noted 1 h after exposure with the test material and persisted until study termination (grade 1). Additionally, the iris appeared flushed and bloody (Days 1 - 13) and circumcorneal injection was observed from Days 6 to 21 (study termination) demonstrating irreversible iridial effects. Conjunctival effects (redness, grade 3)) were observed 1 h after exposure with the test material until Day 13 of the study. From Days 13 - 21 conjunctival effects were still observed to a lesser extend (grade 2) but indicating irreversible effects. Chemosis (grade 2) was also recorded 1 h after exposure with the test material but was slightly reverted (grade 1) within 24 h and persisted until study termination. The results of this test indicate the substance to be a severe irritant to the eye using the procedure described. Thus, according to OECD TG further testing for ocular irritancy should not be performed with additional animals.

Other effects:

No symptoms of systemic toxicity were observed in any animal during the test period and no mortality occurred during the course of the study.

Any other information on results incl. tables

Table 1: Summary of individual eye effects

Observation time	Cornea	Iris	Conjunctivae (rednee)	Chemosis
1 h	3	1	3	2
24 h	2	1	3	1
48 h	2	1	3	1
72 h	2	1	3	1
6 d	2	circumcorneal injection	3	1
8 d	2	circumcorneal injection	3	1
10 d	2	circumcorneal injection	3	1
13 d	2	circumcorneal injection	3	1
17 d	2	circumcorneal injection	2	1
21 d	2	circumcorneal injection	2	1
Mean value of 24 + 48 + 72 h	2	1	3	1

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS Category 1 (H318) according to Regulation (EC) No 1272/2008

Conclusions:

In an in vivo acute eye irritation/corrosion study in the rabbit according to OECD guideline 405 no signs of systemic toxicity were observed in the animals during the test period and no mortality occurred. However, the results of this test indicate the substance to be a severe irritant to the eye using the procedure described. Thus, according to OECD guideline 405 further testing for ocular irritancy should not be performed with additional animals and thus, the test material is considered to be classified as severe eye irritant (Eye Dam. Cat 1, H318) according to Regulation (EC) No 1272/2008.