Registration Dossier
Registration Dossier
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EC number: 476-160-4 | CAS number: 54807-34-0
Skin irritation / corrosion
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:
- 1 986
- 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 substance name:
- 5,5-dimethylhydantoin
- EC Number:
- 201-051-3
- EC Name:
- 5,5-dimethylhydantoin
- Cas Number:
- 77-71-4
- IUPAC Name:
- 5,5-dimethylimidazolidine-2,4-dione
- Reference substance name:
- dimethylhydantoin
- IUPAC Name:
- dimethylhydantoin
- Details on test material:
- Identification: 5,5-Dimethylhydantoin (CAS 77-71-4)
Description: white crystalline solid
Storage cond.: RT in the dark
Constituent 1
Constituent 2
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.
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