1-Butanamine, N-[3-(trimethoxysilyl)propyl]-, reaction products with (trimethoxysilyl)-N-[(trimethoxysilyl)propyl]-1-propanamine and 1,6-diisocyanatohexane homopolymer

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

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

Reference substance name:

iGloss Crosslinker (ZQ54-2211)

IUPAC Name:

iGloss Crosslinker (ZQ54-2211)

Details on test material:

- Name of test material (as cited in study report): iGloss Crosslinker (ZQ54-2211)
- Physical state: Liquid (highly viscous)/ yellowish, clear
- Analytical purity: Mn 1200 Da; Mw 1800 Da; PDI 1.5; Relative RI-area of compounds with M 250-500 Da: 1.7% and with M 250-1000 Da: 29.1%; determined with Gel Permeation Chromatography
- Lot/batch No.: 294222
- Storage condition of test material: Room temperature; no direct sunlight; protect against humidity
- Other: The test item was homogeneous by visual inspection.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: Approx. 3 months
- Weight at study initiation: 2.29 kg – 2.77 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: for at least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): in fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye of the same animals

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test item the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: 24 hours

SCORING SYSTEM: according to OECD 405 guideline

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0

Reversibility:

other: no corneal opacity was observed

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0

Reversibility:

other: no iris lesions were observed

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0.6

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: mean individual scores: 0.3 in 1/3 animals, 0.7 in 2/3 animals

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

0

Reversibility:

other: slight chemosis was only observed 1 hour after application of the substance

Any other information on results incl. tables

In two animals slight conjunctival redness (grade 1) was noted at 1 and 24 hours after application and persisted in one of these animals until hour 48.
Obvious conjunctival redness (grade 2) was noted in one animal 1 hour after application. In this animal grade 2 decreased to slight conjunctival redness (grade 1) and was noted from hour 24 until hour 48.

Slight conjunctival chemosis (grade 1) was noted in two out of three animals 1 hour after application only.

In two animals obvious discharge (grade 2) was noticed 1 hour after application; while one animal showed slight discharge (grade 1) at the same reading point.

 

Additionally injected scleral vessels in a circumscribed area were observed in two animals 1 hour after application only.
In one animal hair loss was noted from hour 24 until hour 72 after application.

 

The ocular reactions were reversible in all animals within 48 or 72 hours after application, respectively.

 

Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 0.7, 0.7 and 0.3 for redness of the conjunctiva and 0.0, 0.0 and 0.0 for chemosis.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU