Hexadecyltrimethoxysilane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12.04.2002 to 30.07.2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

(adopted 1997)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Hexadecyltrimethoxysilane

EC Number:

240-464-3

EC Name:

Hexadecyltrimethoxysilane

Cas Number:

16415-12-6

Molecular formula:

C19H42O3Si

IUPAC Name:

hexadecyltrimethoxysilane

Details on test material:

- Name of test material (as cited in study report): Silan 25013 VP
- Substance type: Alkoxysilane
- Physical state: Colourless liquid
- Stability under test conditions: At 25°C: > 1 year.
- Storage condition of test material: Room temperature, excluded humidity, tightly closed.

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Laboratory of Pharmacology and Toxicology, Löhndorf, GERMANY
- Age at study initiation: 2.5-3.5 months
- Weight at study initiation: 2.4 kg
- Housing: 1/cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 55±15
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2002-04-15 To: 2002-05-03

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye is the control in each case

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 ml

Duration of treatment / exposure:

Single administration, not irrigated. Observed up to 72 h.

Observation period (in vivo):

1, 24, 48, 72 h.

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: after Draize, according to OECD 405

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Reversibility:

other: reversibility: not applicable

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility: not applicable

Results 4

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 5

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Conjunctival redness (grade 1) at 1 h and 24 h; conjunctival chemosis (grade 1) at 1 h. No corneal or iridial effects, or any other observations. The overall irritation score (24, 48, and 72 h) was 0.3 (max. score 13).

Other effects:

None.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility	Cornea	Iris	Conjunctival redness	Conjunctival chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	0/0/0	0/0/0	1/1/1	1/1/1
24 h	0/0/0	0/0/0	1/1/1	0/0/0
48 h	0/0/0	0/0/0	0/0/0	0/0/0
72 h	0/0/0	0/0/0	0/0/0	0/0/0
Average 24h, 48h, 72h	0/0/0	0/0/0	0.3/0.3/0.3	0/0/0
Maximum average score (max 13)	0	0	0.3	0
Reversibility*	-	-	c	c
Average time (unit) for reversion	-	-	48 h	24 h

* Reversibility: c. = completely reversible; n. c. = not completely reversible; n. = not reversible

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:

In an eye irritation study conducted according to OECD 405 and GLP (reliability score 1), hexadecyltrimethoxysilane was not irritating to the eyes of rabbits. There were no other effects reported.