Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986-03-18 to 1986-03-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed to GLP and equivalent to 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 404 (Acute Dermal Irritation / Corrosion)
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.: 1083:45
- Stability under test conditions: stable in crystalline form
- Storage condition of test material: the test material was stored at room temperature, in the darkness and in the same container in which it was received.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hare Haven Rabbitry, Middleboro, MA
- Weight at study initiation: 2.39-2.78 kg
- Housing: all animals were housed in a test room
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: three days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 50 ± 20%
- Air changes (per hr): 10 to 15 air exchanges per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped
Vehicle:
water
Controls:
other: right dorsal flank of each animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 500 mg moistened with sterile water before application.
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours.
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- Coverage area: 6 cm2


REMOVAL OF TEST SUBSTANCE
- Washing: Residual susbtance was removed by washing with sterile water for injection U.S.P.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring scale.

Draize JH "Dermal toxicity" appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics. Association of Food and Drug Officials of the US, 1959, 3rd printing 1975, pp.46-59.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
There was no erythma, eschar, or edema formation in any of the rabbits at any time. Since no positive reactions were observed at the 72 hour observation the study was considered completed at that time.

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 skin