4-[fluoro(dimethyl)silyl]butanenitrile

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September 23 - November 14, 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-[fluoro(dimethyl)silyl]butanenitrile

EC Number:

812-925-4

Cas Number:

1639345-42-8

Molecular formula:

C6H12FNSi

IUPAC Name:

4-[fluoro(dimethyl)silyl]butanenitrile

Test material form:

liquid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Weight at study initiation: >2 kg
- Housing: ABS - plastic rabbit or Noryl rabbit cages, floor 4200 cm²
- Diet: ad libitum, Altromin 2123 maintenance diet for rabbits, rich in crude fibre
- Water: ad libitum, tap water
- Acclimation period: adequate

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

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effect observed

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 5

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 7

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 3 days

Results 8

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 9

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 6 days

Results 10

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 3 days

Irritant / corrosive response data:

First time of effects:
animal no. 1: 1 hour post-application redness grade 1 and chemosis grade 2; moderate hypersecretion
animal no. 2: 1 hour post-application redness grade 1 and chemosis grade 3; moderate hypersecretion
animal no. 3: 1 hour post-application redness grade 2 and chemosis grade 2; moderate hypersecretion

Other effects:

- Lesions and clinical observations: Neither mortalities nor significant clinical signs of toxicity but local effects were observed
- Ophthalmoscopic findings: Corneal lesions upon fluorescein examinations were found in the treated eye of all animals 72 hours
after test item application and in the treated eye of animal no. 2 on day 5 in the prolonged
observation period.
- Other observations: The body weight development of all animals was within the expected range

Applicant's summary and conclusion

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Conclusions:

Under the conditions of the present study, a single ocular application of the test item 3-Cyanopropyldimethylfluorosilane to rabbits at a dose of 0.1 mL produced mild irritant effects, which were fully reversible within 6 days in animals no. 1 and no. 3 and 7 days in animals no. 2. Neither mortalities nor significant clinical signs of toxicity but local effects were observed.

Executive summary:

The test for acute eye irritation/corrosion according to OECD Guideline No. 405 was performed with the test item. In this eye irritation study the test item was applied to the lower conjunctival sac of one eye of 3 New Zealand White Rabbits Crl: KBL (NZW) at a dose of 0.1 mL per application site. The untreated other eye served as control.

Observations were calculated and compared to the control eyes, 1 h, 24 h, 48 h and 72 hours after application of the test item.

The test item produced mild irritant effects, which were fully reversible within 6 days in animals no. 1 and no. 3 and 7 days in animal no. 2. Neither mortalities nor significant clinical signs of toxicity but local effects were observed.