Registration Dossier
Registration Dossier
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EC number: 700-095-5 | CAS number: 203448-76-4
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)
- Rationale for reliability incl. deficiencies:
- other: GLP study according OECD / EU guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-(4-methylpentan-2-yl)aniline
- EC Number:
- 700-095-5
- Cas Number:
- 203448-76-4
- Molecular formula:
- C12 H19 N
- IUPAC Name:
- 2-(4-methylpentan-2-yl)aniline
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0%, 2 %, 10% and 50% v/v
- No. of animals per dose:
- 6
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: 0%: 1.0 2%: 0.76 10%: 0.7 50%: 1.03
Any other information on results incl. tables
Based on results obtained in validation studies and general experiences with this test system groups of mice were treated with vehicle, 2%, 10% or 50% in A/OO.
The NMRJ mice did not show an increase in the stimulation indices for cell counts or for weights of the draining lymph nodes after application of the test item.
The "positive level" which is 1.4 for the cell count index was never reached or exceeded in any dose group.
The "positive level" of ear swelling, which is 0.02 mm increase , i.e. about 10% of the control values, has not been reached or exceeded in any dose group.
No substance specific effects were determined for ear weights either.
On day 4 a slight statistically significant increase in ear swelling had been determined for group 3 and a slight statistically significant decrease in ear weights had been determined for group 4. These changes are, however, within the normal range of variance for these
parameters, which means that it is only of statistical significance because the mathematical conditions were favorable.
No other substance specific effects were determined.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- This study does neither point to a non-specific (irritant) nor to a specific immunostimulating (sensitizing) potential of the test item.
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