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Diss Factsheets
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EC number: 201-108-2 | CAS number: 78-35-3
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Grey literature deficient in some details of methodology but considered adequate for the purposes of hazard identification and classification.
Data source
Reference
- Reference Type:
- grey literature
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- no assessment of iris effects
- Principles of method if other than guideline:
- Pre-dates but broadly comparable to OECD 405
- GLP compliance:
- no
- Remarks:
- pre-dates GLP
Test material
- Reference substance name:
- 1,5-dimethyl-1-vinylhex-4-enyl isobutyrate
- EC Number:
- 201-108-2
- EC Name:
- 1,5-dimethyl-1-vinylhex-4-enyl isobutyrate
- Cas Number:
- 78-35-3
- Molecular formula:
- C14H24O2
- IUPAC Name:
- 1,5-dimethyl-1-vinylhex-4-enyl isobutyrate
- Reference substance name:
- Unknown impurities
- Molecular formula:
- not applicable
- IUPAC Name:
- Unknown impurities
- Test material form:
- liquid
Constituent 1
impurity 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- No information available
Test system
- Vehicle:
- other: Applied undiluted and as a 5% concentration in diethyl phthalate
- Controls:
- other: The untreated eyes of each rabbit served as controls
- Amount / concentration applied:
- 0.1mL
- Duration of treatment / exposure:
- No information
- Observation period (in vivo):
- Observations of the eyes were made immediately and 1, 2, 4, 24, 48 and 72 hours later. Fluorescein was used to check corneal damage. Scoring of the eyes was done by the method of Draize.
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- No additional details
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- (undiluted)
- Basis:
- mean
- Time point:
- other: mean 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant, no effects observed
- Remarks on result:
- other: o corneal findings were reported in any rabbit
- Irritation parameter:
- conjunctivae score
- Remarks:
- (undiluted)
- Basis:
- mean
- Time point:
- other: Mean 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Initial conjunctival erythem (Grade 1) had resolved by 24 hours
- Irritation parameter:
- chemosis score
- Remarks:
- (undiluted)
- Basis:
- mean
- Time point:
- other: Mean 24, 38, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not relevant, no effects observed
- Remarks on result:
- other: No chemosis was observed in any rabbit
- Other effects:
- No information available
Any other information on results incl. tables
Undiluted Linalyl Isobutyrate |
At instillation | 1 Hour | 2 Hours | 4 Hours | 24 Hours | 48 Hours | 72 Hours | |||||||||||||||
Rabbit | A | B | C | A | B | C | A | B | C | A | B | C | A | B | C | A | B | C | A | B | C | |
Cornea- Opacity |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Cornea- Area Involved | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Pupil Reaction | + | + | + | + | + | + | + | + | + | + | + | + | + | + | + | + | + | + | + | + | + | |
Conjunctiva- Redness | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Conjunctiva- Chemosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Conjunctiva- Discharge | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||||
5% Linalyl Isobutyrate | Instillation | 1 Hour | 2 Hours | 4 Hours | 24 Hours | 48 Hours | 72 Hours | |||||||||||||||
Rabbit | A | B | C | A | B | C | A | B | C | A | B | C | A | B | C | A | B | C | A | B | C | |
Cornea- Opacity |
0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Cornea- Area Involved | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Pupil Reaction | + | + | + | + | + | + | + | + | + | + | + | + | + | + | + | + | + | + | + | + | + | |
Conjunctiva- Redness | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Conjunctiva- Chemosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
Conjunctiva- Discharge | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Undiluted Linalyl Isobutyrate was found to be a minimal eye irritant under the conditions of this study and does not require classification as an eye irritant according to the CLP Regulation.
- Executive summary:
Instillation of 0.1 mL undiluted Linalyl Isobutyrate into the eyes of three rabbits resulted in mild transient conjunctival erythema which resolved within 24 hours. Instillation of a 5% dilution of Linalyl Isobutyrate resulted in mild transient conjunctival erythema which resolved within 1 hour. Undiluted Linalyl Isobutyrate was found to be a minimal eye irritant under the conditions of this study and does not require classification as an eye irritant according to the CLP Regulation. While iris effects were not specifically assessed in this study, no effects of treatment were observed on pupil reaction. This deviation from the guideline is not considered to be critical.
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