N-(cyclohexylthio)phthalimide

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(cyclohexylthio)phthalimide

EC Number:

241-774-1

EC Name:

N-(cyclohexylthio)phthalimide

Cas Number:

17796-82-6

Molecular formula:

C14H15NO2S

IUPAC Name:

N-(cyclohexylthio)phthalimide

Details on test material:

Test batch No.: 041/07
Active substance: 99,42 % weight
Weight loss: 0,08 % weight
Toluene insolubles: 0,05 % weight
Ash: 0,008 % weight
Melting point: first liquid 92,3°C
complete liquid 92,5 °C
Sieve retention: 2,0 mm 0 %
0,5 mm 0 %

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

NZW (albino) rabbits from SCPV Nitra, Slovakia,
Number: 3 males Initial weight: > 3kg
Housing Conditions: Animals were housed individually in metallic cages.
Environment: Environmental controls for the animal room was set to maintain 18± 3°C, a relative humidity of 55± 10% a minimum of 10 air changes/hour. Lighting was artifitial, the sequence being 12h light, 12h dark.
Acclimation: 20days
Diet: A standard certified laboratory diet äsupplier Top Dovo Dobrá Voda) was served. the diet is routinely analysed by the manufacturer for nutriotional components and environmental contaminants.
Water: Ad libitum.
Identification of animals: The animals were marked by serial numbers 1 - 3. These numbers were placed on cages.

Test system

Vehicle:

other: Olivae oleum raffinatum

Controls:

other: each animal serves as its own control

Amount / concentration applied:

Duslin (100 mg) was pulverized, moistened sufficiently with olivae oleum raffinatum and apply to right eye. Before the study the animals were quarantined for 20 days in the conditions identical to the conditions during the experiment. Test article was applied in a single dose to right eye of the rabbits. The links eye was used as the control. The degree of eye irritation was evaluated scoring lesions of conjuctiva, cornea, iris and lids at 1, 24, 48 and 72 hours after application.

Duration of treatment / exposure:

Test article was applied in a single dose to right eye of the rabbits.

Observation period (in vivo):

Observation period : 1, 24, 48 and 72 hour after test

Number of animals or in vitro replicates:

3 animals: NZW albino rabbits

Details on study design:

The study Duslin. Acute toxicity:Eye Irritation/Corrosion (OECD 405) was performed according to SOP 096/215/02 in complince with the OECD
Guidelines for Testing of Chemicals - Method No 405 Acute Eye Irritation/Corrosion, 2002 (OECD 405) and Principle of Good Laboratory Practice.
SCORING SYSTEM: OECD 405

TOOL USED TO ASSESS SCORE: hand lamp with magnifying glass

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

other: 1,24,48,72h

Score:

>= 0 - <= 1

Max. score:

3

Reversibility:

fully reversible

Results 2

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

other: 1,24,48, 72h

Score:

>= 0 - <= 1

Max. score:

3

Reversibility:

fully reversible

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

other: 1, 24, 48, 72h

Score:

>= 0 - <= 1

Max. score:

3

Reversibility:

fully reversible

Results 4

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 1, 24, 48, 72h

Score:

>= 0 - <= 1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: lids (swelling)

Results 5

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 1, 24, 48, 72h

Score:

>= 0 - <= 1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: lids (swelling)

Results 6

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 1, 24, 48, 72h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: lids (swelling)

Irritant / corrosive response data:

Duslin had moderate irritant effect on rabbit´s eyes. Duslin had not corrosive effect on rabbit´s eyes. Ocular lesions were reversibility.

Other effects:

Eyes of all animals were normal 72 hours after application of Duslin.

Any other information on results incl. tables

Some blood vessels were hyperaemic (injected) in conjunctivae of all rabbits 1 hour after Duslin application. This change had continued in two rabbits 24 hours after application and lids of the same rabbits had swollen above norma in this time. The findings in conjuctives and swelling of lids were observed in rabbits No. 1 and 2 still 48 hours after application of test article. All changes in conjuctives and lids had value of 1 grad. Eyes of all animals were normal 72 hours after application of Duslin.

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS