Reaction mass of 2-{[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and 2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-[2-(benzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-benzyl-2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-benzyl-N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993-04-22 - 1993-05-18

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(1984)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 2-{[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and 2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-[2-(benzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-benzyl-2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-benzyl-N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride.

Molecular formula:

Not applicable

IUPAC Name:

Reaction mass of 2-{[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and 2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-[2-(benzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride and N-benzyl-2-{benzyl[3-(trimethoxysilyl)propyl]amino}ethanaminium chloride and N-benzyl-N-[2-(dibenzylamino)ethyl]-3-(trimethoxysilyl)propan-1-aminium chloride.

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): ORGANOFUNCTIONAL SILANE A-1128
- Physical state: clear yellow-brown viscous liquid
- Lot/batch No.: D0674-TG-021892
- Expiration date of the lot/batch: 1993-08-31
- Stability under storage conditions: The test substance (as supplied) is stable. The purified test substance (after pretreatment) is stable for two days when stored under nitrogen.
- Storage condition of test material: at room temperature, dry in the dark
- Specific gravity: 0.942 (25 °C)
- Density of pretreated test substance: 1.11 g/ml (determined at RCC NOTOX)
- Test substance pretreatment: The test substance as provided by the sponsor contains approximately 50% (w/w) methanol. Before use, the methanol was evaporated below 30 °C using a rotary evaporator and a water jet. The flask was flushed with nitrogen before loading it with the test substance and after evaporation of the methanol. After evaporation, a reduction of 49.3% in weight was obtained. The test substance was used at the day of preparation.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approximately 15 weeks
- Weight at study initiation: 2944 g
- Housing: The animal was housed under standard laboratory conditions. The animals was individually housed in a labelled cage with perforated floor and equipped with an automatic drinking system (ITL, Bergen, The Netherlands). The animal was identified by ear tag.
- Diet: standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden, The Netherlands) approximately 100 g/day. Certificates of analysis were examined and then retained in the RCC NOTOX archives.
- Water (ad libitum): tap-water diluted with decalcified water. Certificates of analysis were examined and then retained in the RCC NOTOX archives.
- Acclimation period: at least 5 days before start of treatment under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (fluctuations were observed, but were not considered to be relevant)
- Humidity (%): 55 (fluctuations were observed, but were not considered to be relevant)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the other eye remained untreated and served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 ml

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

22 days

Number of animals or in vitro replicates:

1 male rabbit

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize scoring system

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:

2

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

Instillation of the test item resulted in adverse effects on the cornea, iris, and the conjunctivae. One hour after instillation, severe redness and chemosis of conjunctivae (both maximal grade) corneal opacity grade 2 and iridic irritation grade 1 were observed. Similar reactions persisted after 24 h and grey/white discolouration of the eyelids and nictitating membrane, as a sign of necrosis, had become apparent. Treatment of the eyes with 2% fluorescein revealed a large area of the cornea showing epthelial damage (90%).
The corneal opacity (grade 2) and epithelial damage persisted until termination, although a slight recovery of the affected area was noted at the end of the observation period.
On days 3 and 4, redness was observed on the outside of the eyelids. Reduced elasticity of the eyelids was noted from day 8 onwards and was still present at termination. The signs of necrosis in the eyelids and/or nictitating membrane had disappeared within 14 days after instillation. The irritation of the conjunctivae had not completely resolved within the observation period. Redness (grade 2) and a small amount of discharge were observed at termination.
The iridic irritation had resolved within 14 days after instillation.
Discharge was observed (mean score 2.7 over 24, 48, and 72 h; max. 3), which was not fully reversible within 21 days.

Based on the results further testing in two subsequent animals was not carried out.

Other effects:

No staining of peri-ocular tissues by the test substance was observed.
No toxic symptoms were observed in the animal during the test period and no mortality occured.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The test item was tested in one rabbit for primary eye irritation/corrosion according to the OECD TG 405 (1987) and in compliance with GLP. The instillation of the test material resulted in adverse effects on the cornea, iris, and conjunctivae. Based on the results, further testing in two subsequent animals was not carried out. Hence, the test item has to be classified as irreversible effects on the eye (Cat 1) according to EC/1272/2008.