Perhydroimidazo[4,5-d]imidazole-2,5-dione

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from5 August 1988 to 29 November 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study is well described and performed according to OECD testing guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

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:

Glycolurile

IUPAC Name:

Glycolurile

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Centre d'élevage Charles River France (76410 Saint Aubin les Elbeuf)
- Age at study initiation: -
- Weight at study initiation: 2.4 kg ± 0.1 kg
- Housing: individually in polystyrene cages
- Diet: Rabbit diet Reference 112C , ad libitum
- Water: filtered water (Millipore membrane 0.22µm)
- Acclimation period: at least 7 days. At receipt animals received a preventive treatment for coccidiosis by administration of a Mucoxid at the dose level of 140/mg/kg/d to their drinking water for 5 days during the acclimation period.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 50 ± 20 %
- Air changes: -
- Photoperiod: 12 hrs dark / 12 hrs light
Temperature and relative humidity were recorded in the animal rooms.

IN-LIFE DATES: 1988-08-12 (day 1 of treament) to 1988-08-15 (day 4).

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 mg

Duration of treatment / exposure:

one instillation (not rinsed)

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to OECD guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

all scores = 0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Remarks:

all scores = 0

Results 3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hours

Remarks on result:

other: see details below

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

< 0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: see details below

Irritant / corrosive response data:

For cornea and iris, all scores in all animals are equal to 0 (no effect).
For conjuntivae redness, some effects were observed in all animals at 1 hour (score 1 or 2) and at 24 hours (score 1); no reactions were observed after 72h.
For chemosis score 1 were observed in 4/6 animals at one hour and this effect was no more observed after 24 hours.

Any other information on results incl. tables

Table : Scores in the 6 animals at 1, 24, 48 and 72 hours

	1 hour	24 hours	48 hours	72 hours
Chemosis	0/0/1/1/1/1	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
Conjunctivae	1/2/1/2/2/1	1/1/1/1/1/0	0/0/0/0/0/0	0/0/0/0/0/0
Iris	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
Cornea	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Glycolurile is not irritating to the eye.

Executive summary:

The substance Glycolurile was tested for eye irritation / corrosion in rabbits according to OECD guideline n°405 and Good Laboratory Practices.

100 mg of the tested substance were placed into the left eye of 6 rabbits. The ocular reactions were observed one hour after instillation and then daily in order to observed their reversibility.

No reaction was observed on the cornea and the iris (scores 0).

For chemosis slight reactions (score 1) were observed on 4/6 animals and these effets disppeared at 24 hours.

Concerning the conjuntivae redness, slight to moderate effects were observed in all animals at 1 hour. They became minimal at 24 hours and no longer observed thereafter.

According to the results of this test, the substance Glycolurile is not considered as irritating to the eyes.