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Diss Factsheets
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EC number: 690-920-4 | CAS number: 494799-38-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- methyl 3-cyclopentyl-1-methyl-1H-indole-6-carboxylate
- Cas Number:
- 494799-38-1
- Molecular formula:
- C16 H19 N O2
- IUPAC Name:
- methyl 3-cyclopentyl-1-methyl-1H-indole-6-carboxylate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): CD 6003 XX
- Physical state: solid
- Stability under test conditions: The test substance appeared to be stable under the conditions of the study; no evidence of instability was observed.
- Analytical purity: 99.7 %
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Frederick, Maryland, U.S.A
- Age at study initiation: ca. 9 weeks
- Weight at study initiation: 18.4 - 23.3 g
- Housing: All mice were housed singly in stainless-steel, wire-mesh cages suspended above cage boards.
- Diet (e.g. ad libitum): PMI Nutrition International, LLC Certified Rodent LabDiet 5002 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12: 12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 5, 10, 25 and 50 %
- No. of animals per dose:
- 5 animals per dose
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: Statistically significant increase in cell proliferation in the test concentration groups compared to the
vehicle control group and/or SIs of greater than or equal to 3.0 indicated a positive response. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- A 25 % concentration of the positive control, HCA, produced dermal sensitization response in mice.
DPM = 4299.20
SI = 5.94
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Concentration 5 % SI = 1.75 Concentration 10 % SI = 2.08 Concentration 25 % SI = 1.80 Concentration 50 % SI = 2.23
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Concentration 5 % DPM = 1106.60 Concentration 10 % DPM = 1313.40 Concentration 25 % DPM = 1136.20 Concentration 50 % DPM = 1411.80
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- Based on the data, CD 6003 XX is not a dermal sensitizer.
- Executive summary:
The objective of this study was to evaluate the potential of CD 6003 XX to produce dermal senitization response in mice using the local lymph node assay ( LLNA ). Five groups of 5 female mice were dosed for 3 consecutive days with 0 % ( vehicle control ), 5 %, 10 %,
25 % and 50 % CD 6003 XX on both ears.N,N-dimethylformamide was used as the diluting vehicle. One group of 5 female mice was dosed for 3 consecutive days with 25 % hexylcinnamaldehyde( HCA ) in 4 : 1 acetone : olive oil ( AOO ) as positive control and one group of 5 female mice was dosed for 3 consecutive days with AAO as positive vehicle control. On test day 5 of the assay, mice received ³H-Thymidine by tail vein injection and were sacrificed approximately 5 hours later. The cell proliferation in the draining auricular lymph nodes of the ears from the test substance group was then evaluated and compared to the vehicle control group.
No statistically significant increases in cell proliferation measurements compared to the vehicle control group were observed at any test concentration. Stimulation indexes of less than 3.0 were observed at all test concentrations of CD 6003 XX. Therefore, the EC3 value for the test substance under the conditions of this study was not calculable. A 25 % concentration of the positive control, HCA, produced dermal sensitization response in mice. Therefore, the LLNA test system was valid for this study with CD 6003 XX. Under the conditions of this study, CD 6003 XX did not produce a dermal sensitization response in mice.
Based on the data, CD 6003 XX is not a dermal sensitizer.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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