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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 273-868-3 | CAS number: 69103-01-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- p-menth-1-en-8-yl acetate
- EC Number:
- 201-265-7
- EC Name:
- p-menth-1-en-8-yl acetate
- Cas Number:
- 80-26-2
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1-methyl-1-(4-methylcyclohex-3-en-1-yl)ethyl acetate
- Reference substance name:
- Myrcenyl acetate
- EC Number:
- 214-262-0
- EC Name:
- Myrcenyl acetate
- Cas Number:
- 1118-39-4
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1,1-dimethyl-5-methylenehept-6-en-1-yl acetate
- Reference substance name:
- (E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- EC Number:
- 308-183-1
- EC Name:
- (E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Cas Number:
- 97890-04-5
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Reference substance name:
- (Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- EC Number:
- 308-184-7
- EC Name:
- (Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Cas Number:
- 97890-05-6
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Reference substance name:
- Geranyl acetate
- EC Number:
- 203-341-5
- EC Name:
- Geranyl acetate
- Cas Number:
- 105-87-3
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (E)-3,7-dimethylocta-2,6-dien-1-yl acetate
- Reference substance name:
- 1-methyl-4-(1-methylethylidene)cyclohexyl acetate
- EC Number:
- 233-564-3
- EC Name:
- 1-methyl-4-(1-methylethylidene)cyclohexyl acetate
- Cas Number:
- 10235-63-9
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 4-isopropylidene-1-methylcyclohexyl acetate
- Reference substance name:
- 4-(5-methyl-1-methylene-4-hexenyl)-1-(4-methylpent-3-enyl)cyclohexene
- EC Number:
- 208-546-3
- EC Name:
- 4-(5-methyl-1-methylene-4-hexenyl)-1-(4-methylpent-3-enyl)cyclohexene
- Cas Number:
- 532-87-6
- Molecular formula:
- C20H32
- IUPAC Name:
- 4-(5-methyl-1-methylenehex-4-en-1-yl)-1-(4-methylpent-3-en-1-yl)cyclohexene
- Reference substance name:
- cis-1-methyl-4-(1-methylvinyl)cyclohexyl acetate
- EC Number:
- 244-028-3
- EC Name:
- cis-1-methyl-4-(1-methylvinyl)cyclohexyl acetate
- Cas Number:
- 20777-47-3
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 4-isopropenyl-1-methylcyclohexyl acetate
- Reference substance name:
- p-menth-1-en-8-ol
- EC Number:
- 202-680-6
- EC Name:
- p-menth-1-en-8-ol
- Cas Number:
- 98-55-5
- Molecular formula:
- C10H16O
- IUPAC Name:
- 2-(4-methylcyclohex-3-en-1-yl)propan-2-ol
- Reference substance name:
- Neryl acetate
- EC Number:
- 205-459-2
- EC Name:
- Neryl acetate
- Cas Number:
- 141-12-8
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (Z)-3,7-dimethylocta-2,6-dien-1-yl acetate
- Reference substance name:
- 1-(3,3-dimethylcyclohex-1-en-1-yl)ethyl acetate
- Cas Number:
- 150461-96-4
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1-(3,3-dimethylcyclohex-1-en-1-yl)ethyl acetate
- Reference substance name:
- Tentative monoterpene diacetate
- IUPAC Name:
- Tentative monoterpene diacetate
- Reference substance name:
- Tentative oxygenated monoterpene acetate
- IUPAC Name:
- Tentative oxygenated monoterpene acetate
- Reference substance name:
- Tentative Diterpene hydrocarbon
- IUPAC Name:
- Tentative Diterpene hydrocarbon
- Reference substance name:
- Unresolved/non-elucidated mixed terpene/diterpene/oxygenated terpene/terpene acetate derivatives
- IUPAC Name:
- Unresolved/non-elucidated mixed terpene/diterpene/oxygenated terpene/terpene acetate derivatives
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
Constituent 12
Constituent 13
Constituent 14
Constituent 15
- Specific details on test material used for the study:
- Identification: Neobergamate Forte
Appearance: Pale yellow liquid
Batch: SC00015234
Purity/Composition: See Certificate of Analysis
Test item storage: At room temperature protected from light
Stable under storage conditions until: 07 November 2016 (expiry date)
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- Species: Mouse, CBA/J strain, inbred, SPF-Quality.
Recognized by the international guidelines as the recommended test system (e.g. OECD, EC, EPA).
Source: Janvier, Le Genest-Saint-Isle, France
Number of animals 20 females (nulliparous and non-pregnant), five females per group (main study only).
Age and body weight Young adult animals (approx. 10 weeks old) were selected. Body weight variation was within +/- 20% of the sex mean.
Identification Tail mark with a marker pen.
Health inspection At least prior to dosing. It was ensured that the animals were healthy and that the ears were intact and free from any abnormality.
Reliability check The results of a reliability test with three concentrations of Hexylcinnamaldehyde (CAS No. 101-86-0) in Acetone/Olive oil (4:1 v/v), performed not more than 6 months previously and using the same materials, animal supplier, animal strain and essential procedures are summarized in APPENDIX 2 of this report. For both scientific and animal welfare reasons, no concurrent positive control group was included in the study.
An extensive data base is available with reliability checks performed at half year intervals during at least the past 9 years showing reproducible and consistent positive results.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Test item concentrations: 10, 25 or 50% w/w
- No. of animals per dose:
- Five animals per dose
- Details on study design:
- Test item concentrations selected for the main study were based on the results of a pre-screen test.
In the main study, three experimental groups of five female CBA/J mice were treated with test item concentrations of 10, 25 or 50% w/w on three consecutive days, by open application on the ears. Five vehicle control animals were similarly treated, but with the vehicle alone (Acetone/Olive oil (4:1 v/v)). Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised and pooled for each animal. After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of disintegrations per minute (DPM) and a stimulation index (SI) was subsequently calculated for each group. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
Any other information on results incl. tables
The very slight erythema was noted for some animals treated at 25% and 50% between Days 3 and 5 was considered not to have a toxicologically significant effect on the activity of the nodes. The majority of auricular lymph nodes were considered normal in size, except for the nodes of all animals treated at 50% and three animals treated at 25%, which were considered slightly enlarged. Mean DPM/animal values for the experimental groups treated with test item concentrations 10, 25 and 50% were 544, 1122 and 2029 DPM, respectively. The mean DPM/animal value for the vehicle control group was 261 DPM. The SI values calculated for the test item concentrations 10, 25 and 50% were 2.1, 4.3 and 7.8, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- These results indicate that Neobergamate Forte could elicit a SI ≥ 3. The data showed a dose-response and an EC3 value (the estimated test item concentration that will give a SI =3) of 16.1% was calculated.
The six-month reliability check with Alpha-hexylcinnamaldehyde indicates that the Local Lymph Node Assay as performed at Charles River Den Bosch is an appropriate model for testing for contact hypersensitivity.
Based on these results and according to the recommendations made in the test guidelines (including all amendments), Neobergamate Forte would be regarded as skin 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.
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.