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EC number: 202-870-9 | CAS number: 100-61-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
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 substance name:
- N-methylaniline
- EC Number:
- 202-870-9
- EC Name:
- N-methylaniline
- Cas Number:
- 100-61-8
- Molecular formula:
- C7H9N
- IUPAC Name:
- N-methylaniline
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Sulzfeld, Germany
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 18.0 g - 21.5 g
- Housing: Makrolon cage type II, one animal per cage, Dust-free wooden bedding, enrichment: PLEXX mouse tunnel, nest building material Nestlets NES 3600
- Diet: ad libitum
- Water: tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): air condition, 20 - 24°C
- Humidity (%): 30 - 70%
- Air changes (per hr): fully airconditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Study design: in vivo (LLNA)
- Vehicle:
- methyl ethyl ketone
- Concentration:
- 10%, 25% and 50% of test substance in vehicle
- No. of animals per dose:
- 5
- Details on study design:
- Groups of 5 female CBA/J mice each were treated with 10%, 25% and 50% w/w preparations of the test substance in MEK or with the vehicle alone. The high concentration was selected based on the presence of systemic toxicity and mortality in a pre-test using the undiluted test
substance.
The study used 3 test groups and 1 control group. Each test animal was treated with 25 μL per ear of the appropriate test-substance preparation, applied to the dorsal surfaces of both ears for three consecutive days. The control group was treated with 25 μL per ear of the vehicle alone.
Three days after the last application the mice were injected into the tail vein with 20 μCi of 3H-thymidine in 250 μL of sterile saline. About 5 hours after the 3H-thymidine injection, the mice were sacrificed and the auricular lymph nodes were removed. Lymph node response was evaluated by measuring 3H-thymidine incorporation (indicator of cell proliferation). Cell counts and weights of each animal’s pooled lymph nodes were also determined. In addition, a 0.8 cm diameter sample was punched out of the apical part of each ear and for each animal the weight of the pooled punches was determined in order to obtain an indication of possible skin irritation.
A concurrent positive control (reliability check) with a known sensitizer was not included in this study. Studies using the positive control substance Alpha-Hexylcinnamaldehyde, techn. 85% are performed twice a year in the laboratory in order to show that the test system is able to detect
sensitizing compounds under the test conditions chosen. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Mean values and standard deviations of the measured parameters were calculated for the test and control groups from the individual values. The stimulation indices of 3H-thymidine incorporation, cell count, lymph node weight and ear weight measurements were calculated as the ratio of the test group mean values for these parameters divided by those of the vehicle control group.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.38
- Test group / Remarks:
- 50 % test group
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 25 % test group
- Parameter:
- SI
- Value:
- 1.72
- Test group / Remarks:
- 10 % test group
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- control group
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 0%: 143.4 +/- 49.2 10%: 246.6 +/- 80.3 25%: 186.7 +/- 73.6 50%: 198.3 +/- 55.9
Any other information on results incl. tables
The mean stimulation indices (expressed as multiples of the vehicle control) for 3H-thymidine incorporation, cell count, lymph node weight and ear weight are summarized for each test group in the table below.
Test Group | Treatment
| ³H-thymidine incorporation Stimulation Index | Cell Count Stimulation Index | Lymph Node Weight Stimulation Index
| Ear Weight Stimulation Index |
1 | vehicle MEK | 1.00 | 1.00 | 1.00 | 1.00 |
2 | 10% in MEK | 1.72 # | 1.01 | 1.12 | 0.99 |
3 | 25% in MEK | 1.30 | 1.01 | 1.12 # | 0.96 |
4* | 50% in MEK | 1.38 | 1.24 # | 1.22 # | 0.96 |
The statistical evaluations were performed using the WILCOXON-test ( # for p ≤ 0.05, ## for p ≤ 0.01 )
* Calculation on basis of 4 animals due to an irregularity during 3H-thymidine injection.
The animals treated with the 50% test-substance concentration showed slightly reduced activity until about 30 minutes after each application. No other signs of systemic toxicity were noticed during the observation period. When applied as 50%, 25% and 10% solution in MEK the test substance did not induce biologically relevant increases in the 3H-thymidine incorporation (no increase above the cut off Stimulation Index of 3) into the cells from the auricular lymph nodes or in lymph node cell counts (no increase to 1.5 fold or above of control value = stimulation index (SI) ≥ 1.5). There was no relevant increase in lymph node weights, as well. However, statistically significant increases were noted for 3H-thymidine incorporation in test group 2, lymph node cell counts in test group 4 and lymph node weights in test groups 3 and 4. All test-substance preparations did not cause any increase in ear weights, demonstrating the absence of ear skin irritation. Thus it is concluded that the test substance does not exhibit a skin sensitizing potential in the Murine Local Lymph Node Assay under the test conditions chosen.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- The test substance did not exhibit a skin sensitizing potential in the Murine Local Lymph Node Assay under the test conditions chosen.
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