5,5-dimethylhydantoin

Skin irritation / corrosion

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

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

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.: 1083:45
- 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 or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 h

Score:

0

Max. score:

0

Results 3

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