Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 214-730-4 | CAS number: 1191-16-8
- 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
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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:
- other: GLP-guideline study,
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Harlan Cytotest Cell Research GmbH
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-methyl-2-butenyl acetate
- EC Number:
- 214-730-4
- EC Name:
- 3-methyl-2-butenyl acetate
- Cas Number:
- 1191-16-8
- Molecular formula:
- C7H12O2
- IUPAC Name:
- 3-methylbut-2-en-1-yl acetate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material: Prenyl acetate
- Physical state: clear, colorless liquid
- Analytical purity: 99.6 area%
- Batch No.: 00002977L0
- BASF Substance No.: 10/0362-2
- Homogeneity: test substance appeared to be homogeneous
- Storage: at room temperature
- Expiration Date: August 24, 2013
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
Pre-test:
- Strain/quality: CBA/CaOlaHsd
- Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst, The Netherlands
Main study:
- Strain/quality: CBA/CaCrl
- Source: Charles River UK, Manston Road, Margate, Kent CT9 4LT, United Kingdom
ENVIRONMENT
- Temperature: 22 + 2°C
- Relative humidity: 31 – 65% (acclimation period), 45 – 65% (pre-test and main study)
- Artificial light: 6.00 a.m. - 6.00 p.m.
- Air changes: about 10 / hour
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50, 100%
- No. of animals per dose:
- 5
- Details on study design:
- RANGE FINDING TESTS:
Body weights, ear weights, ear thickness (using a micrometer) and erythema scoring was assessed in 1 animal/ conc. tested (50%, 100% prenyl acetate)
TREATMENT PREPARATION AND ADMINISTRATION:
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear with test item concentrations of 25, 50, and 100% in acetone:olive oil (4+1 v/v). The application volume, 25 µL/ear/day, was spread over the entire dorsal surface of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone.
Five days after the first topical application (day 6) 250 µL of phosphate-buffered saline (PBS) containing 20.2 µCi of 3HTdR (equivalent to approximately 80.9 µCi/mL 3HTdR) were injected into each test and control mouse via the tail vein. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- A statistical analysis was conducted on the DPM values, the ear weights, the lymph node weights and the lymph node cell count. A One-Way-Analysis-of-Variance was used as statistical method. In case of significant results of the One-Way-ANOVA, multiple comparisons were performed with the Dunnett test or the Student Newman Keuls test. Statistical significance was set at the five per cent level (p < 0.05). The Dean-Dixon-Test was used for identification of possible outliers. However, both biological and statistical significance were considered together.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Stimulation Indices (3H-Methyl Thymidine incorporation) of 0.98, 1.10 and 2.92 at concentrations of 25, 50% and 100%. Indices (mean lymph node weight of test item group related to vehicle group): 1.05, 10.3, 1.57 at concentrations of 25, 50% and 100%. Indices (mean lymph node cell count of test item group related to vehicle group): 1.17, 1.16, 2.01 at concentrations of 25, 50% and 100%.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see table
Any other information on results incl. tables
Calculation of Stimulation Incices per Dose Group:
Test item concentration |
Group Calculation | ||
Mean DPM per animala) | SDb) | S.I. | |
Vehicle (acetone:olive oil (4+1 v/v)) | 1127.8 | 321.4 | 1.00 |
25 % Prenyl acetate | 1110.2 | 224.3 | 0.98 |
50 % Prenyl acetate | 1243.4 | 492.6 | 1.10 |
100 % Prenyl acetate | 3290.4* | 972.9 | 2.92 |
a) Mean DPM/animal was determined by dividing the sum of the measured values from lymph nodes of all animals within a group by the number of animals in that group
b) SD = Standard Deviation
* statistically significant increase vs. control group (p<0.05)
The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed. Body weights were within the range commonly recorded for animals of this strain and age.
A statistically significant increase in ear weights was not observed in any test item treated group in comparison to the vehicle control group. Furthermore, the cutoff-value for the ear weight index of 1.1 (reported for BALB/c mice for a positive response regarding ear skin irritation) was not exceeded in any dose group.
Applicant's summary and conclusion
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.
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