Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
March 18-21, 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study has been performed on DMH (Dimethyl Hydantoin )in compliance with the FDA's GLP regulations (21 CFR 58) and has been used for read-across purposes.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Primary Dermal Irritation, Environmental Protection Agency Toxic Substances Control Act Test Guidelines, 40 CFR Part 798.4470
Principles of method if other than guideline:
Dermal irritation was scored according to the methods of Draize (Draize, J.H., "Dermal Toxicity").
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Identification: 5,5-Dimethylhydantoin (CAS 77-71-4)
Description: white crystalline solid
Storage cond.: RT in the dark

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:
shaved
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:
30-60 min, and then at 24, 48 and 72 hours following patch removal.
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:
animal: 1-6
Time point:
other: 1 hour, 24 hours, 48 hours, 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 1-6
Time point:
other: 1 hour, 24 hours, 48 hours, 72 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: 1-6
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
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.
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: OECD GHS
Conclusions:
Results from the Primary Dermal Irritation Test suggest that DMH is considered non-irritating when tested on laboratory animals according to TSCA Test Guidelines.
Executive summary:

Results from the Primary Dermal Irritation Test suggest that DMH is considered non-irritating when tested on laboratory animals according to TSCA Test Guidelines.