Registration Dossier

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: Study performed to GLP and equiavlent to a guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 5,5-dimethylhydantoin (DMH)
- Physical state: white crystals
- Analytical purity: not stated
- Lot/batch No.: 1083:32
- Stability under test conditions: stable in aqueous solution over a week time.
- Storage condition of test material: stored at room temperature, in the darkness, in the same container in which it was received.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Not stated (a registered commercial breeding laboratory)
- Age at study initiation: Not stated
- Weight at study initiation: 2.68-4.30 kg
- Housing: individually housed in stainless steel rabbit cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 42-48 %
- Air changes (per hr): 10-15 room air changes
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Test system

Vehicle:
not specified
Controls:
other: the left eye remaining untreated served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):

VEHICLE
- No vehicle used

PREPARATION OF TEST ARTICLE
- Prior to administration, the test material was finely pulverised by using a porcelain mortar and pestle.
Duration of treatment / exposure:
The upper and lower lids were gently held together for approximately 1 second. The eyes were not washed out.
Observation period (in vivo):
1, 24, 48, 72 hours and 7 days.
Preliminary observation was also carried out before application of test substance.
Number of animals or in vitro replicates:
3/sex
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: none
- Anaesthetic: no anaesthetic used.

SCORING SYSTEM: Draize.

TOOL USED TO ASSESS SCORE: Fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.89
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.5
Irritant / corrosive response data:
The application of the substance did not produce any effect to cornea or iris of the eye. A Conjunctivae effect was reversible within 7 days, showing an irritation effect of DMH to the eye with no corrosive effect.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
DMH is not irritating to eyes