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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
5,5-dimethylhydantoin
EC Number:
201-051-3
EC Name:
5,5-dimethylhydantoin
Cas Number:
77-71-4
Molecular formula:
C5H8N2O2
IUPAC Name:
5,5-dimethylimidazolidine-2,4-dione
Constituent 2
Reference substance name:
dimethylhydantoin
IUPAC Name:
dimethylhydantoin
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