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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Only 10 animals in test group.
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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Mineral oil
Concentration / amount:
75%
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: Mineral oil
Concentration / amount:
75%
No. of animals per dose:
10 animals
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: The test substance was applied once per week until a total of 3 induction applications had been made.
- Concentrations: 75%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Challenge performed 13 days after last induction application
- Concentrations: 75%
- Evaluation (hr after challenge): 24 and 48
Positive control substance(s):
yes
Remarks:
1-chloro-2, 4- dinitrobenzene (DNCB)

Results and discussion

Positive control results:
Positive control gave the expected response

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DMH is not a skin sensitizer (not classified)