Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 928-489-4 | CAS number: 194984-24-2
- 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:
- Experimental start date: 17 october 2012 - Experimental completion date: 4 december 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD, GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- 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
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- N-(1-cyanocyclopentyl)pentanamide
- EC Number:
- 928-489-4
- Cas Number:
- 194984-24-2
- Molecular formula:
- C11H18N2O
- IUPAC Name:
- N-(1-cyanocyclopentyl)pentanamide
- Test material form:
- other: 100 % solution
- Details on test material:
- Identification: Valeroyl-aminonitrile oil
Description: Liquid
Lot/batch number: 2U291
Certificate of analysis: 13 september 2012
Storage conditions bulk material: between 2°C and 8°C
Purity: 92.4°C
Expiry date: september 2013
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: BALB/c N
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories France, Les Oncins, BP0109, 69592 L'Arbresle Cedex, France
- Age at study initiation: approx. 8 to 12 weeks
- Weight at study initiation: approx. 20 +/- 4 g
- Total No. of animals on study: 4 animals/group
- Housing: Housed 4/cage in type "1290D" cages made of transparent polycarbonate. Space allocated: 820 cm² x 15.5 cm
- Diet (e.g. ad libitum): Irradiated controlled pelleted rodent diet (re. AO4C-10, SAFE)
- Water (e.g. ad libitum): free acess to tap water through bottles
- Acclimation period: for at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C to 24°C
- Humidity (%): 40 to 75 %
- Photoperiod (hrs dark / hrs light): 12h/12h cycle
Study design: in vivo (LLNA)
- Vehicle:
- unchanged (no vehicle)
- Concentration:
- 100 %
- No. of animals per dose:
- 4
- Details on study design:
- Experimental schedule:
- Day 1 to day 3: treatment (once daily): open application of 25 µL of the appropriate dilution of the test article or the positive control , or the vehicle alone to the dorsum of both ears.
- Day 4 and day 5: no treatment
- Day 6: injection (tail vein) of 250 µL of sterile phosphate-buffered saline (D-PBS) containing 20 µCi of 3H-methylthymidine to all animals. Approximately five hour later, animals will be sacrified and the draining auricular lymph nodes excised and pooled in D-PBS for each experimental group.
Preparation of cell suspension:
A signle cell suspension of lymph node cells (LNC) is prepared for each pooled sample by gentle mechanical disaggregation through 100 µm Nylon Cell Strainer. The cells are washed twice with an excess of D-PBS and DNA precipitated with 5% trichloroacetic acid (TCA) for approximately 18 hours, in the refrigerator. After centrifugation, the supernatant is discarded and the pellet resuspended in 1mL TCA and transferred to vials, then 10 mL of scintillation fluid for 3H- counting are added.
Determination of incorporated 3H-methyl thymidine
Incorporation of 3H-methyl thymidine is measured by beta-scintillation counting as disintegrations per minute (DPM) for each experimetal group (total DPM) with a beta-scintillation counter Wallac.
Criteria used to consider a positive response: A test article is considered as a skin sensitizer when the stimulation index (SI) >= 3 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No statistical analysis was performed.
Results and discussion
- Positive control results:
- HCA at 25% :
Total DPM/group: 17339.2;
Mean DPM/node: 2167.4;
Simulation index: 13.2
Acceptance criteria validated: SI is greater than 3
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 4.5
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Total DPM/group: 5877.1 Mean DPM/node: 734.6
Any other information on results incl. tables
No mortality was observed during the study.
No systemic toxicity or local irritation on application sites were noted in any of the treated animals.
Body weight variations in Valeroil-aminonitrile-treated group animals were similar to those observed in the vehicle control group animals.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, under these experimental conditions, the test article Valeroil-aminonitrile was found positive in the local lymph node assay and has to be classified as a skin sensitizer in Category 1 of the Globally Harmonized Classification System (GHS).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.