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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:
1986
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

Constituent 1
Chemical structure
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
- Lot/batch No.: S86.001.3161

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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