Registration Dossier
Registration Dossier
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EC number: 701-388-0 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 March 2007 to 27 March 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 1,3-bis(2-hydroxyethyl)-5,5-dimethylimidazolidine-2,4-dione
- EC Number:
- 701-388-0
- Cas Number:
- 26850-24-8
- IUPAC Name:
- 1,3-bis(2-hydroxyethyl)-5,5-dimethylimidazolidine-2,4-dione
- Test material form:
- other: pale yellow solid block
- Details on test material:
- - Name of test material (as cited in study report): Dantocol DHE
- Physical state: pale yellow solid block
- Lot/batch No.: M5469330
- Storage condition of test material: room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 10%, 25% or 50% w/w
- No. of animals per dose:
- 4/treatment group
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- Not specified.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 1.48
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 1.36
- Test group / Remarks:
- 50%
Any other information on results incl. tables
There were no deaths and no signs of systemic toxicity were noted in the test or control animals during the test.
| Concentration (%w/w) in dimethyl formamide | Stimulation Index | Result |
| Vehicle | N/A | N/A |
| 10 | 1.00 | Negative |
| 25 | 1.48 | Negative |
| 50 | 1.36 | Negative |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was considered to be a non-sensitiser based on a SI of less than 3 for all treatment groups.
- Executive summary:
In an in vivo local lymph node assay to evaluate the sensitisation potential of the substance mice (4 animals/treatment group) were exposed to the substance for 3 consecutive days at concentrations 10%, 25% or 50% w/w. Another group of 4 animals received the vehicle alone. The SI for all treatment groups was below 3 and thus indicates that the substance is not a sensitiser.
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