Hydroxytrimethylsilane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

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:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Remarks:

Therefore assumed not to GLP

Test material

Test material information

Constituent 1

Reference substance name:

Hydroxytrimethylsilane

EC Number:

213-914-1

EC Name:

Hydroxytrimethylsilane

Cas Number:

1066-40-6

Molecular formula:

C3H10OSi

IUPAC Name:

hydroxytrimethylsilane

Details on test material:

- Name of test material (as cited in study report): Trimethylsilanol
- Substance type: Alkylsilane
- Physical state: Liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hacking and Churchill Ltd., Huntingdon, UK
- Age at study initiation: No data
- Weight at study initiation: approximately 3.8 kg
- Housing: No data
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: No data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: No data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

Three male

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with saline after 24 hours

SCORING SYSTEM: Draize


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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 21 days

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.7

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2.3

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Results 8

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 9

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 10

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

All animals had grade 1 corneal opacity at 60 minutes, which increased in severity (to grade 2) in one animal at 24 and 48 hours. All animals had conjunctival redness (grade 1-3) and conjunctival oedema (chemosis: grade 1-2). All opacity and conjunctival effects were reversed by seven days after treatment. There were no effects on the iris.

Other effects:

No other effects

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	Conjunctivae	Chemosis
	Max. score: 4	Max. score: 2	Max. score: 3	Max. score: 4
60 min	1/1/1	0/0/0	2/2/2	1/1/2
24 h	1/1/2	0/0/0	2/2/3	1/1/1
48 h	0/0/2	0/0/0	2/2/2	1/1/2
72 h	0/0/2	0/0/0	1/1/2	0/0/0
Average 24h, 48h, 72h	0.3/0.3/2	0/0/0	1.7/1.7/2.3	1/1/1.7
Reversibility*)	c/c/c	-	c/c/c	c/c/c
Time (unit) for reversion		-	By 72 hours	By 72 hours

 

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an eye irritation study conducted to OECD 405, but not to GLP (reliability score 2), trimethylsilanol was slightly irritating to the eyes of three male rabbits following a 24 hour exposure. The irritation did not meet the EU criteria for classification.