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EC number: 239-405-4 | CAS number: 15373-31-6
- 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:
- 2015-05-11 to 2015-06-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- 2010
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2,2,3-trimethylcyclopent-3-enylacetonitrile
- EC Number:
- 239-405-4
- EC Name:
- 2,2,3-trimethylcyclopent-3-enylacetonitrile
- Cas Number:
- 15373-31-6
- Molecular formula:
- C10H15N
- IUPAC Name:
- 2-(2,2,3-trimethylcyclopent-3-en-1-yl)acetonitrile
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Jcr
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley; Indianapolis, IN
- Age at study initiation: 8.5 weeks (Date Born: 10 Apr 15)
- Weight at study initiation: 19.2-23.2 g
- Housing: 1-5 per cage, Polycarbonate boxes with bedding
- Diet: ad libitum, PMI Feeds Inc.™ Formulab #5008
- Water: ad libitum, Municipal water supply analyzed by TCEQ Water Utilities Division
- Acclimation period: 5 days quarantine
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-28
- Humidity (%): 49-91
- Air changes (per hr): 10+
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50 and 100 %
- No. of animals per dose:
- 5 (female)
- Details on study design:
- RANGE FINDING TESTS: was not conducted
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: open application
- Criteria used to consider a positive response: EC3
TREATMENT PREPARATION AND ADMINISTRATION:
Five females were selected for each of three Test groups (Groups I - III). On Days 1, 2 and 3, each Test animal in its group received an open application of 25 µL of appropriate dilution (25 or 50 %) of test item in 4:1 v/v acetone:olive oil vehicle, or 100 % test item, to the dorsum of both ears. The Vehicle Control group (5 females) was treated the same way as test animals, but with vehicle alone instead of test item. The Positive Control group (5 females) was treated with 100 % alpha-hexylcinnamaldehyde. All Test and Control animals were given a two-day rest period on Days 4 and 5.
On Day 6 of the study, all Test and Control animals were injected in the tail vein with 250 µL of 0.01 M phosphate-buffered saline (PBS; Sigma, Lot SLBJ110V, Exp Jun 2024), pH 7.4 at 25°C per manufacturer, containing 20 µCi of [methyl-3H] Thymidine (PerkinElmer, Lot 201408, Exp Aug 2015). Five hours after injection, animals were sacrificed with an overdose of CO2, the draining auricular lymph nodes excised and pairs from each individual animal processed.
Observations
Individual body weights were recorded on Day 1 prior to dosing, and Day 6. prior to injection. All Test and Control animals were observed daily for clinical signs of toxicity and any signs of excessive irritation at the test site. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- A one-way parametric analysis of variance (ANOVA) with Dunnett's Multiple Comparisons Test was performed on the DPM counts. If the test groups showed a stimulation index (SI) of > 3, then the extrapolated EC3 (estimated concentration required for a 3-fold stimulation index value) was calculated from the stimulation index values at 25% and either the 50% or 100% concentration and the substance was assessed as a weak, moderate- strong or extreme sensitizer.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Please refer to "Any other information on results".
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Please refer to "Any other information on results".
Any other information on results incl. tables
Body weight
One animal in each of Test Groups I and II lost weight during the study.
Clinical signs
All animals appeared normal for the duration of the study.
Stimulation Index or Test/Vehicle Control Ratio derived for each Test group based on group mean DPM:
Animal Group |
Test Item Concentration [%] |
Average DPM Count per Mouse |
Number of Mice in Group |
Test/Vehicle Control Ratio (Stimulation Index) |
Vehicle Control |
NA |
534 |
5 |
NA |
Test Group I |
25 |
599 |
5 |
1.1 |
Test Group II |
50 |
579 |
5 |
1.1 |
Test Group III |
100 |
814 |
5 |
1.5 |
Positive Control |
NA |
2490 |
5 |
4.7* |
NA - Not applicable
* - Positive Control used to confirm animal sensitization potential and validate procedures
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance induced a stimulation index of < 3 in all test groups. Therefore it was considered to be not sensitising.
- Executive summary:
A skin sensitization study was conducted on 3 groups of 5 female mice to determine if test item Cantryl possessed a significant potential to cause skin sensitization. Five females were assigned to each of three groups, designated Groups I - III. Test groups were treated with an appropriate dilution (25 or 50 %) in 4:1 v/v acetone:olive oil, or 100 % test item. Each animal received 25 µL to the dorsum of each ear. Animals were treated once daily for three days. After a two-day rest period, all animals were injected with tritiated methyl-thymidine in the tail vein. Five hours later, animals were sacrificed, and the draining auricular lymph nodes removed and prepared for cell suspension and scintillation counting. A Vehicle Control group of five females was run concurrently, treated in the same manner with vehicle only instead of test item or dilution. A Positive Control group of five females was also run concurrently, treated with 100 % alpha-hexylcinnamaldehyde.
The test item produced a stimulation index < 3 in all groups of test animals, and therefore was not a senitizer.
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