Registration Dossier
Registration Dossier
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EC number: 201-051-3 | CAS number: 77-71-4
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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 guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Test group consisted of 10 animals while 20 is recommended in test method guidelines
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- 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
- Reference substance name:
- dimethylhydantoin
- IUPAC Name:
- dimethylhydantoin
- Details on test material:
- - Name of test material (as cited in study report): 5,5-dimethylhydantoin
- Lot/batch No.: S86.001.3161
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hartley derived-albino
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley, Inc.
- Weight at study initiation: 300-500 g
- Housing: individually housed in suspended stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 75% DMH (w/v mineral oil suspension)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- 75% DMH (w/v mineral oil suspension)
- No. of animals per dose:
- 5/sex/dose
- Details on study design:
- RANGE FINDING TESTS:
A preliminary dose range-finding study was performed prior to the start of the sensitisation study to evaluate the dermal irritation potential of the test article at concentrations of 75%, 50%, 30% and 20% in mineral oil. No dermal irritation was observed at the evaluated concentrations thus the 75% DMH concentration was used for the induction and challenge applications in the sensitisation study.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 3 weeks
- Test groups: 5/sex
- Control group (naive control group): 5/sex
- Site: left shoulder area
- Frequency of applications: once per week
- Duration: 3 weeks
- Concentrations: 75% w/v of DMH into mineral oil
B. RESTING PERIOD
- Duration: 13 days
C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: not stated
- Exposure period: 6 hours
- Test groups: 5/sex
- Control group: 5/sex
- Positive control group: 3/sex
- Site: posterior left flank
- Concentrations: 75% w/v of DMH into mineral oil
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- 5 males and 5 females were challenged topically with 0.4 ml of 75% DMH.
- Positive control substance(s):
- yes
- Remarks:
- 0.3% 1-chloro-2,4-dinitrobenzene (DNCB) in 95% ethanol (induction step) followed by 0.02% and 0.2% of DNCB in challenge step.
Results and discussion
- Positive control results:
- Exposure of guinea pigs to the positive control (DNCB) resulted in a significant delayed contact hypersensitivity response in 100% of the DNCB induced animals. This response demonstrates that the test system is capable of detecting potential sensitizers.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 6
- Group:
- test chemical
- Dose level:
- 75 % DMH w/v mineral oil suspension
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not specified
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 6.0. Group: test group. Dose level: 75 % DMH w/v mineral oil suspension. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Not specified.
- Reading:
- 2nd reading
- Hours after challenge:
- 6
- Group:
- test chemical
- Dose level:
- 75% DMH w/v mineral oil suspension
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Not specified
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 6.0. Group: test group. Dose level: 75% DMH w/v mineral oil suspension. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Not specified.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.2% DNCB in acetone
- No. with + reactions:
- 6
- Total no. in group:
- 6
- Clinical observations:
- Not specified
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.2% DNCB in acetone. No with. + reactions: 6.0. Total no. in groups: 6.0. Clinical observations: Not specified.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.2% DNCB in acetone
- No. with + reactions:
- 4
- Total no. in group:
- 6
- Clinical observations:
- Not specified
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.2% DNCB in acetone. No with. + reactions: 4.0. Total no. in groups: 6.0. Clinical observations: Not specified.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- DMH did not elicit a sensitisation response in the assay therefore it can be concluded that DMH is not a skin sensitizer.
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