p,p'-dinitrobibenzyl

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

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:

1,1'-ethane-1,2-diylbis(4-nitrobenzene)

EC Number:

212-001-5

Cas Number:

736-30-1

Molecular formula:

C14H12N2O4

IUPAC Name:

1,1'-ethane-1,2-diylbis(4-nitrobenzene)

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.87 -3.28 kg
- Housing: individually in suspended metal cages
- Diet: Rabbit Diet, Preston Farmers Limited, New Leake, Boston, Lincolnshire, U.K.) (ad libitum):
- Water: drinking water (ad libitum):
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 21
- Humidity (%): 60 - 68
- Air changes (per hr): approximately 15
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The left eye remained untreated and was used for control purposes

Amount / concentration applied:

0.1 ml (was found to be approximately 71 mg) was placed into the right eye of each rabbit

Duration of treatment / exposure:

single application without rinsing

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

SCORING SYSTEM:
cornea: 0 - 4
iris: 0 - 2
conjunctivae: 0 - 3
chemosis: 0 - 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: # 131, 86, 25 each

Time point:

other: mean of 24, 48, 72h

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (cornea) at any time point

Results 2

Irritation parameter:

iris score

Basis:

animal: # 131, 86, 25 each

Time point:

other: mean of 24, 48, 72h

Score:

0

Max. score:

2

Reversibility:

other: no signs of irritation (iris) at any time point

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: # 131, 25 each

Time point:

other: mean of 24, 48, 72h

Score:

0

Max. score:

3

Reversibility:

other: initial slight signs of irritation were fully reversible within 24h

Results 4

Irritation parameter:

conjunctivae score

Basis:

animal: # 86

Time point:

other: mean of 24, 48, 72h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48h

Results 5

Irritation parameter:

chemosis score

Basis:

animal: # 131, 86, 25 each

Time point:

other: mean of 24, 48, 72h

Score:

0

Max. score:

4

Reversibility:

other: initial slight signs of irritation were fully reversible within 24h

Other effects:

no other effects reported

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test materia was found to be non-irritant to the rabbit eye

Executive summary:

The substance was tested for eye irritation according to OECD guideline 405. 0.1 ml of the substances was applicated into the right eye of each of 3 New Zealand White rabbits.

No corneal opacity and iridial effects were noted during the study period of 72 hours. Conjunctival rednes was noted in two animals one hour after treatment and in one aniaml at the 24-hour reading. No other conjunctival irritation was noted. All signs of irritation were fully reversible within 48h.