Trimethoxypropylsilane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06 - 12 May 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted 1981

Deviations:

yes

Remarks:

incomplete details on the identity and purity of the test substance.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trimethoxypropylsilane

EC Number:

213-926-7

EC Name:

Trimethoxypropylsilane

Cas Number:

1067-25-0

Molecular formula:

C6H16O3Si

IUPAC Name:

trimethoxy(propyl)silane

Test animals / tissue source

Species:

rabbit

Strain:

other: Albino White Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Asta-Werke AG, Bielefeld, GERMANY
- Age at study initiation: 6 months
- Weight at study initiation: 2.0-2.4 kg
- Housing: individually in stainless-steel cages (Model: ASTA)
- Diet: Sniff standard diet for rabbits, but no indication of whether it was ad libitum
- Water: Ad libitum
- Acclimation period: at least one day

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2
- Humidity (%): 55 +/-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
- Concentration: n/a - neat

Duration of treatment / exposure:

Single application without washing

Observation period (in vivo):

6 days
Reading time points: 1, 24, 48 and 72 h and then once daily until Day 6 (scores for Days 4-6 are not given in the report)

Number of animals or in vitro replicates:

3 males

Details on study design:

SCORING SYSTEM: Draize scoring system

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

Reversibility:

other: reversibility not applicable

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: 6 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility not applicable

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

Results 8

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.67

Max. score:

3

Reversibility:

fully reversible within: 6 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 6 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

Irritation index of 10.4 (out of a total possible of 110) was judged, in the report, to fall within the range 0-10 indicating no irritation.

Other effects:

No systemic toxicity was detected.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time

Score at time point / Reversibility*	Cornea		Iris	Conjunctivae
	Opacity - Max. score 4 (a)	Area - Max. score 4 (b)	Max. - score 2 (c)	Redness - Max score 3 (d)	Chemosis - Max. score 4 (e)	Discharge -Max. score 3 (f)
60 min	0/0/0	0/0/0	0/0/0	2/3/3	0/2/0	0/1/1
24 h	0/1/0	0/4/0	0/1/0	1/3/2	0/2/0	0/1/0
48 h	0/1/0	0/4/0	0/0/0	0/3/2	0/1/0	0/0/0
72 h	0/1/0	0/4/0	0/0/0	0/2/1	0/0/0	0/0/0
Average 24h, 48h, 72h	0.3	1.3	0.1	1.6	0.3	0.1
Mean scores (3 animals; 4 time points) out of maximum possible	5/80		0.4/10	5/20
Total score (irritation index)** (max 110)	10.4/110

*Each entry shows values for each of the 3 animals

**Maximum total score irritation index = ([axbx5] + [cx5] + [(d+e+f)x2])/18

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008

Conclusions:

A reliable eye irritation study, conducted according to OECD 405 but not GLP, reported an irritation index of 10.4 out of 110. The index was judged in the report to indicate that the test material was not irritating to the eyes of rabbits. This finding would concur with a reading according to CLP/EU GHS criteria.