Registration Dossier
Registration Dossier
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EC number: 247-722-4 | CAS number: 26471-62-5
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:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- m-tolylidene diisocyanate
- EC Number:
- 247-722-4
- EC Name:
- m-tolylidene diisocyanate
- Cas Number:
- 26471-62-5
- Molecular formula:
- C9H6N2O2
- IUPAC Name:
- 2,4-diisocyanato-1-methylbenzene, 2,6-diisocyanato-1-methylbenzene
- Details on test material:
- TDI (Bayer, Germany)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0, 0.03, 0.1, 0.3, 1.0, and 3.0 %
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
TREATMENT PREPARATION AND ADMINISTRATION: Mice exposed topically on dorsum of both ears to 25 µL test material or an equal volumen of acetone:olive oil alone daily for 3 days. Five days after first exposure mice injected intravenously into tail vein with H-3 thymidine in PBS. After 5 hours the mice were sacrificed, the lymph notes were excised and pooled. A single cell suspension was prepared, washed and precipitatide with 5 % TCDA. Incorporation of H-3 thymidine was counted as dpm per node per group, compared to controls and was recorded as the stimulation index (SI). - Positive control substance(s):
- other: oxazolone, TMA, DCNB
Results and discussion
- Positive control results:
- All positive SI.
In vivo (LLNA)
Results
- Key result
- Parameter:
- EC3
- Value:
- 0.02
- Remarks on result:
- other: EC3 value calculated, see overall remarks
Any other information on results incl. tables
Treatment Group |
DPM/node x 10-3 |
SI |
Vehicle (AOO) |
0.225 |
1.00 |
0.03 % TDI |
0.964 |
4.27 |
0.1 % TDI |
1.264 |
5.59 |
0.3 % TDI |
4.366 |
19.33 |
1.0 % TDI |
10.7 |
47.37 |
3.0 % TDI |
5.39 |
23.86 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1A (indication of significant skin sensitising potential) based on GHS criteria
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