Registration Dossier
Registration Dossier
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EC number: 203-680-9 | CAS number: 109-55-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Extrapolating local lymph node assay EC3 values to estimate relative sensitizing potency
- Author:
- Ryan CA, Kern PS, Dearman RJ, Kimber I and Basketter DA
- Year:
- 2 007
- Bibliographic source:
- Cutaneous and Ocular Toxicology, 26, 135-145, 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-aminopropyldimethylamine
- EC Number:
- 203-680-9
- EC Name:
- 3-aminopropyldimethylamine
- Cas Number:
- 109-55-7
- Molecular formula:
- C5H14N2
- IUPAC Name:
- N,N-dimethylpropane-1,3-diamine
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 7 - 12 weeks
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0.5; 1.0; 2.5; 5.0; 10.0%
- No. of animals per dose:
- a minimum of 4 animals
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 13.9
- Test group / Remarks:
- 10% test substance
- Parameter:
- SI
- Value:
- 3.5
- Test group / Remarks:
- 5% test substance
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 1.0% test substance
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 0,5% test substance
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Vehicle: 463 Test material: 0.5%: 597 1.0%: 486 2.5%: 1626 5.0%: 3223 10.0%: 6417
Any other information on results incl. tables
EC3: 2.2% (EC3 value derived by linear interpolation);
EC3: 2.3% (EC3 values derived by log-linear extrapolation).
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
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