Registration Dossier
Registration Dossier
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EC number: 252-939-2 | CAS number: 36265-41-5
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12.09.2018 to 31.10.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- July 22, 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 30 May, 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- March 2003
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate
- EC Number:
- 252-939-2
- EC Name:
- Didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate
- Cas Number:
- 36265-41-5
- Molecular formula:
- C33H59NO4
- IUPAC Name:
- didodecyl 1,4-dihydro-2,6-dimethylpyridine-3,5-dicarboxylate
- Test material form:
- solid: particulate/powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
Sex: female (nulliparous and non-pregnant)
Age at the
beginning of the study: 9 - 10 weeks
Number of animals: 5 mice / group
5 mice / prescreen test
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 3%, 6.25%, 12.5%
- No. of animals per dose:
- 5
- Positive control substance(s):
- other:
Results and discussion
- Positive control results:
- not sensitising
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- >= 1.6 - <= 2.1
- Test group / Remarks:
- The DPM at a concentration of 3% was 1490.8
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
- Key result
- Parameter:
- SI
- Value:
- >= 1.1 - <= 1.4
- Test group / Remarks:
- The DPM at a concentration of 6.25 % was 1033.5
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
- Key result
- Parameter:
- SI
- Value:
- >= 1 - <= 1.6
- Test group / Remarks:
- The DPM at a concentration of 12.5% was 937.2
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- The DPM for the negative control was 928.4
- Remarks on result:
- no indication of skin sensitisation based on QSAR/QSPR prediction
Any other information on results incl. tables
There was no mortality and there were no significant clinical observations or effects on body weights.
None of the three tested concentrations of the test item reached the stimulation index of 3.
The stimulation index at a concentration of 3% was 1.6
The stimulation index at a concentration of 6.25% was 1.1
The stimulation index at a concentration of 12.5% was 1.0
There were no relevant increases in lymph node weight in any of the test groups.
The mean weight of the lymph nodes
for the 3% test group was 2.5 mg
for the 6.25% test group was 2.3 mg
for the 12.5% test group was 2.1 mg
for the negative-control group was 2.2 mg
Applicant's summary and conclusion
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