2-(isopropylthio)-3-(2,2,2-trifluoroethoxy)pyridine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline and GLP compliant study with good documentation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-(isopropylthio)-3-(2,2,2-trifluoroethoxy)pyridine

EC Number:

696-441-7

Cas Number:

256473-05-9

Molecular formula:

C10H12F3NOS

IUPAC Name:

2-(isopropylthio)-3-(2,2,2-trifluoroethoxy)pyridine

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The right eye of each animal served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL per left eye

Duration of treatment / exposure:

The eyes were not rinsed after administration of the test substance.

Observation period (in vivo):

The test duration was 72 hours since there was no evidence for irritation.

Number of animals or in vitro replicates:

3 males

Details on study design:

SCORING SYSTEM:
Commission directive 93/21/EEC of 27 April 1993 adapting to technical progress for the eighteenth time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances.

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, 2 and 3

Time point:

other: 1, 24, 48, and 72 h

Score:

0

Max. score:

4

Remarks on result:

other: no effect

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, 2 and 3

Time point:

other: 1, 24, 48, and 72 h

Score:

0

Max. score:

2

Remarks on result:

other: no effect

Results 3

Irritation parameter:

chemosis score

Basis:

animal: # 1 and 3

Time point:

other: 1

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Results 4

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 1 hour

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

other: Redness of Conjuctivae

Basis:

animal: # 1, 2 and 3

Time point:

other: 1 and 24 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

 According to the classification criteria set out in Directive 67/548/EEC and Regulation (EC) No. 1272/2008 the substance does not fulfil the criteria for classification as irritant to eye.

Executive summary:

The acute eye irritation of ITTFEP (purity 82.3%) to rabbit (New Zealand White) was determined in a GLP compliant test according to OECD 405 and EU Method B.5 (Griffon 2001). Since the study was performed under GLP and according the guideline and based on the good documentation the study was awarded with Klimisch 1. For the acute eye irritation testing in 3 male rabbits (approx. weight of 3065 to 3571 g at the start of the test) 0.1 mL test item was administered to the conjunctional sac of the left eye after gently pulling the lower lid away from the eyeball. The untreated right eye served as control.

 

The eyes were examined according the EU specifications after addition of fluorescein. Since there was no evidence for irritaion, the test was terminated after 72 hours. Very slight or slight conjunctival reactions including very slight or slight chemosis (grade 1 or 2) and very slight or slight redness of the conjunctiva (grade 1 or 2) were observed on all animals on day 1; these reactions persisted up to day 2 at latest.

Mean scores calculated for the three animals over 24, 48, and 72 hours were 0 for coronal opacity, 0 for iris lesions, 0.1 for chemosis and 0.3 for redness of the conjunctiva.

 

There were no remarkable clinical observations during the study.

 

It can be concluded that under the experimental conditions the test substance is non irritant when administered by ocular route to rabbits.

 

According to the classification criteria set out in Directive 67/548/EEC and Regulation (EC) No. 1272/2008 the substance does not fulfil the criteria for classification as irritant to eye.