Hexyltrimethoxysilane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

06.05.1987 to 12.05.1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to 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:

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

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
- Diet: Standard diet used, but no indication of whether it was ad libitum
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2
- Humidity (%): 55 +/-15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1987-05-06 To: 1987-05-12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 ml
- Concentration: n/a - neat

Duration of treatment / exposure:

Single application

Observation period (in vivo):

6 days

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
Unclear if eyes were washed following treatment.

SCORING SYSTEM: Draize

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:

Total score 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:

The report notes that 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** (max 110)	10.4/110

*Each entry shows values for each of the 3 animals

**Maximum total score = [axbx5] + [cx5] + [(d+e+f)x2]=110

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 a Draize score of 10.4 out of 110. The score 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 EU criteria.