3-(biphenyl-4-yl)-6-(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

The study was performed between 14 September 2009 and 17 september 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study has been performed in accordance with the study plan, the OECD Guidelines for testing of chemicals N° 405 (24th April 2002), with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

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

Test material

Test material information

Constituent 1

Reference substance name:

3-{[1,1'-biphenyl]-4-yl}-6-(4-chlorophenyl)-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione

EC Number:

700-341-1

Cas Number:

105194-34-1

Molecular formula:

C24H15ClN2O2

IUPAC Name:

3-{[1,1'-biphenyl]-4-yl}-6-(4-chlorophenyl)-1H,2H,4H,5H-pyrrolo[3,4-c]pyrrole-1,4-dione

Constituent 2

Reference substance name:

3-(biphenyl-4-yl)-6-(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione

IUPAC Name:

3-(biphenyl-4-yl)-6-(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione

Details on test material:

Name: PDE-28
Batch N° 1RF-8017
Appearance: powder dark red
Storage conditions: Room temperature, in the dark
Manufacturer: TOYO INK Mfg, Co, LTD

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Only animals in acceptable health condition were used for the test. Both eyes of each animals provisionally selected for testing were examined approximately one hour before starting the study. animals showing eye irriation, ocular defects or pre-existing corneal injury were not used.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

A single dose of 0,1 g of thr solid test item PDE-28 was adminstred to each animal.

Duration of treatment / exposure:

The eyes of the test animal were washed out at one hour after application of test item.

Observation period (in vivo):

The eyes were exminated at 1, 24, 48, and 72 hours after treatment. The diration of the observation was sufficient to identify reversibility or irreversibility of changes.

Number of animals or in vitro replicates:

Three animals in acceptable health condition were selected for the test.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

chemosis score

Basis:

animal: animal's individual mean score

Time point:

other: considering reading at 24, 48, and 72 hours after treatment

Score:

> 0 - <= 0.33

Max. score:

0.33

Reversibility:

fully reversible

Results 2

Irritation parameter:

iris score

Basis:

animal: animal's individual mean score

Time point:

other: considering reading at 24, 48, and 72 hours afetr treatment

Score:

ca. 0

Max. score:

0

Reversibility:

fully reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal: animal's individual mean score

Time point:

other: considering reading at 24, 48, and 72 hours

Score:

ca. 0

Max. score:

0

Reversibility:

fully reversible

Irritant / corrosive response data:

The tests item PDE-28, applied to rabbit eye mucosa, caused significant conjunctival irritant effects at one hour which were reduced at 24 hours after application. The effects were fully reversible within 72 hours.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item PDE-28 applied to rabbit eye mucosa, caused significant conjonctival irritant effects at one hour which reduced at 24 hours after application. The effect were fully reversible within 72 hours.

Executive summary:

An accute eye irritaion study of the test item PDE-28 was performed in New Zeland White rabbits. The irritation efects of the tests item where evaluated accordind to the Draize method (OECD N° 405, 2002).

The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. An amount of 0,1g of the solid test item was administred as a single dose. The eye of the test animals were washed out at one hour afetr the application of the test item.

The eye were examinated at 1, 24, 48, and 72 hours after the application.

Initail pain Reaction (IPR) (score 2) was observed in two animals with IPR (score 3) noted in one animal.

One hour after the application:

Conjunctival redness (sccore 2) was observed in two animals, conjunctival redness (score 1) in one animal, discharge (score 3) was found in one animal, discharge (score 2) in one animal and discharge (score 1) in one animal. Two rabbits showed conjunctival chemosis (score 1).

At 24 hours after treatment:

conjunctival redness (score 2) was observed in one annimal and conjunctival redness (score 1) in two animals. Conjunctival chemosis (score 1) was found in one rabbit, and conjunctival discharge discharge (score 1) in all animals.

At 48 hours after treatment:

Conjjunctival redness (score 1) was observed in one animal and conjunctival discharge (score 1) was found in one animal.

At 72 hours after treatment:

There where no clinical signs observed.

As there were no clinical signs observed, the study was terminated after 72 hours observation.

During the study, the control eye of the animals was symptom-free.

No notable body wheigt changes during the study period.

The animal's individual mean scores (considering readings at 24, 48, &nd 72 hours afetr treatment) were as follow:

chemosis: 0.00, 0.33, 0.00

Discharge: 0.33, 0.33, 0.67

Redness: 0.33, 1.00, 0.33

cornea opacity: 0.00, 0.00, 0.00

Iris: 0.00, 0.00, 0.00