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EC number: 942-532-4 | CAS number: -
- 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
- Study period:
- From August 12,2013 to September 3,2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test conducted according to internationally accepted testing guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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:
- NACET00502
- IUPAC Name:
- NACET00502
- Reference substance name:
- 3-Methyl-5-(2,2,3-trimethylcyclopentyl)pentan-2-one
- Cas Number:
- 119464-63-0
- Molecular formula:
- C14H26O
- IUPAC Name:
- 3-Methyl-5-(2,2,3-trimethylcyclopentyl)pentan-2-one
- Test material form:
- other: light yellow oil
Constituent 1
Constituent 2
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 Japan
- Age at study initiation: 8 weeks of age
- Weight at study initiation: 20.4 to 23.5 g.
- Housing: were individually housed in wire mesh metal cages (W 10.0 x D 19.6 x H 13.0 cm). The feeders were exchanged once a week
- Diet: free access to commercial pellet diet, CRF-1
- Water: free access to tap water with an automatic water supply system
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26°C
- Humidity (%): 35 to 70 %
- Air changes (per hr): 12 times or more per hour
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light (lights on 7 a.m., off 7 p.m.)
Study design: in vivo (non-LLNA)
- Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Groups Test substance N°of animals
1 vehicle alone 4
2 25% test substance 4
3 50% test substance 4
4 100% test substance 4
5 25% α-Hexylcinnamaldehyde 4 - No. of animals per dose:
- 4 females x 5 groups (negative control, positive control and 3 doses)
- Details on study design:
- RANGE FINDING TESTS: A pre-screening test [Exp. No. E93 1 (432-028), non-GLP] was conducted before this main study to determine the concentrations for dosing. In the pre-screening test, three concentrations of 25, 50 and 100% (Acetone and olive oil mixture was used as a solvent, excluding 100% solution) were selected, and 25 µl each of the dose formulations were applied on the dorsal skin of both auricles of each animal, 2 mice for each concentration, once a day for 3 consecutive days.
The general conditions including the application site condition were observed from 1 to 3 hours after the application on each day of application. As a result, no animals showed any abnormalities. The body weights and ear thickness were measured before the initial application and on Day 6. As a result, none of the animals showed any changes deviating from the criteria of body weights.
From the results mentioned above, for the main study, 100% was selected as the high concentration because it was expected not to induce any toxic general condition, 25% or more increase of the ear thickness, dermal erythema with score of 3 or more on the auricles, or more than 5% of body weight loss, and two lower concentrations of 50 and 25% (three concentrations in total).
TREATMENT PREPARATION AND ADMINISTRATION: The undiluted solution of the test substance was used for 100% dose formulation 0.5 ml of the test substance was dissolved in the same volume of acetone and olive oil mixture (AOO) to make the concentration of 50%. 0.5 ml of this solution was diluted with the same volume of AOO to make the concentration of 25%. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No statistical analysis was used.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- The SI for the 25, 50 and 100 % NACET00502 groups were calculated to be 2.1, 2.6 and 3.0, respectively. Therefore, NACET00502 was judged as positive, and the EC3 value of NACET00502 was calculated as 100% via quadratic regression. On the other hand, DPM/animal of the positive control group was 5,475.6, and the SI of this group was calculated as 4.8.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The DPM/animal of the vehicle control group and 3 test substance groups (25, 50 and 100 %) were 1145.8, 2420.9, 2982.5 and 3420.1, respectively.
Any other information on results incl. tables
No animals showed abnormal clinical signs due to test substance administration during the observation period, no animals showed erythema on the auricles during the observation period.
There were no body weight increases or decreases due to test substance or positive control substance administration during the sensitization period. The weights of lymph nodes in all test substance groups and the positive control group were higher than that in the vehicle control group. No animals showed increases of ear thickness during the sensitization period.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- NACET00502 was judged to be a sensitizer under the conditions of this study, and was categorized in sub-category 1B of GHS and 1272/2008 classification for skin sensitization.
- Executive summary:
A mouse local lymph node assay (LLNA) was conducted to investigate the potential of NACET00502 to induce allergic contact dermatitis. Female CBA/J [SPF] mice were purchased from Charles River Laboratories Japan, Inc., and 20 mice were used for this study. There were 5 dose groups, each consisting of 4 mice, and the animals in each group were exposed to NACET00502 at 1 of the 3 concetration levels, positive control substance or their vehicle (acetone and olive oil mixture: v/v=4: 1).
The results are summarized as follows. The stimulation indices (SI) for the 25, 50 and 100 % NACET00502 groups were calculated to be 2.1, 2.6 and 3.0, respectively. These results were judged to be positive. On the other hand, the SI for the 25 % α-Hexylcinnamaldehyde (HCA, positive control) was calculated to be 4.8, which was judged to be positive. No animals showed abnormal clinical signs due to test substance administration during the observation period. No animals showed erythema on the auricles during the observation period. The ear thicknesses of all animals were not increased during the sensitizing period. There were no body weight increases or decreases due to test substance administration during the sensitization period. The weights of lymph nodes in all test substance groups and the positive control group were higher than that in the vehicle control group. In conclusion, NACET00502 was judged to be a sensitizer under the conditions of this study, and was categorized in sub-category 1B of GHS and 1272/2008 classification for skin sensitization.
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