Registration Dossier
Registration Dossier
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EC number: 445-760-8 | CAS number: -
Toxicological information
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- DBA
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: dimethylformamide (DMF)
- Concentration / amount:
- 0.25%
0.5%
1%
2.5%
5%
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: dimethylformamide (DMF)
- Concentration / amount:
- 0.25%
0.5%
1%
2.5%
5%
- No. of animals per dose:
- 4 feamles
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0.25%
0.5%
1%
2.5%
5% - No. of animals per dose:
- 4 female
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 144.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0,25. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0,25. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 144.0. Group: test group. Dose level: 0,25. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0,5. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0,5. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0,5. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 144.0. Group: test group. Dose level: 0,5. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 1. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 144.0. Group: test group. Dose level: 1. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2,5. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 2,5. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 144.0. Group: test group. Dose level: 2,5. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 5. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: no.
- Parameter:
- other: Migrated information from in vivo LLNA study
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 144.0. Group: test group. Dose level: 5. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: slight increase in ear thickness.
- Parameter:
- SI
- Remarks on result:
- other: 0.25% 1.17 0.5% 1.06 1% 1.52 2.5% 0.68 5% 1.21 positive control 15
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: negative control 71.80 0.25% 84.16 0.5% 75.88 1% 108.92 2.5% 48.54 5% 86.90 positive control 1077.12
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test item is not hypersensitivity
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