Bis(triethoxysilylpropyl)amine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 Oct - 03 Nov 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit

Test material

Test material information

Constituent 1

Reference substance name:

Bis(triethoxysilylpropyl)amine

EC Number:

236-818-1

EC Name:

Bis(triethoxysilylpropyl)amine

Cas Number:

13497-18-2

Molecular formula:

C18H43NO6Si2

IUPAC Name:

bis(triethoxysilylpropyl)amine

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand White Rabbits Crl:KBL (NZW)

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: approximately 26 - 28 weeks old
- Weight at study initiation: > 2 kg
- Housing: ABS-plastic rabbit cages, floor 4200 cm²
- Diet: autoclaved hay and to Altromin 2123 maintenance diet for rabbits (lot no. 0724) ad libitum rich in crude fibre
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated contralateral eye served as control

Amount / concentration applied:

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

Duration of treatment / exposure:

single application without rinsing

Observation period (in vivo):

13 days
Reading time points: 1, 24, 48, and 72 h and daily up to 13 days post-application

Number of animals or in vitro replicates:

2 females

Details on study design:

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:

0.67

Max. score:

4

Reversibility:

fully reversible within: 11 d

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 10 d

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 6 d

Results 4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 9 d

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 13 d

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 13 d

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 13 d

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 10 d

Irritant / corrosive response data:

One hour post exposure, effects on iris (grade 1, 2/2 animals), conjunctivae redness (grade 1 and 2, 2/2 animals) and chemosis (grade 3, 2/2 animals), were observed. In addition, discharge (grade 2) was observed in both animals at 1 h and was fully reversible within 13 days. Mean values over 24, 48, and 72 h for cornea were 0.67 and 1, respectively. After 48 h in both animals corneal opacity was 100% and the irises were red and discoloured. After 72 h cornea opacity was 50% in animal 1 and 2. Mean scores over 24, 48, and 72 h for iris were 0.67 and 1 respectively. Conjuntivae redness mean scores were 2 and 3, respectively. Chemosis mean score was 2.33 in both animals. Any effect observed was fully reversed at the end of the observation period.

Other effects:

The body weight development of both animals during the observation period was within the expected range.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are met, Category 2 (irritating to eyes) classification required according to Regulations (EC) No 1272/2008

Conclusions:

CLP: eye irrit. Cat. 2 (H319)

Under the conditions of the present study, a single ocular application of the test item Bis(triethoxysilylpropyl)amine to rabbits at a dose of 0.1 mL produced irritant effects, which were fully reversible within 13 days. Neither mortalities nor significant clinical signs of toxicity were observed.