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EC number: 279-399-0 | CAS number: 80118-06-5
- 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, other
- Remarks:
- Old in-vivo study from 1979 so no new amnimals have been used.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 13, 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to 16 CFR 1500.42 (US) test guideline. The study was conducted prior to the OECD Test Guideline No. 405 but the protocol is similar to that guidance.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Section 1500.42 - Hazardous Substances and Articles, Administration and Enforcement Regulations, Federal Register, Vol. 38. No. 187, p. 27019, 27 September 1973.
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (no details on test animals and environmental conditions)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,3-dimethylbut-3-enyl isobutyrate
- EC Number:
- 279-399-0
- EC Name:
- 1,3-dimethylbut-3-enyl isobutyrate
- Cas Number:
- 80118-06-5
- Molecular formula:
- C10H18O2
- IUPAC Name:
- 4-methylpent-4-en-2-yl 2-methylpropanoate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): MT-102 Methylpentenol isobutyrate
- Physical state: Clear colorless liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: approved USDA supplier
- Weight at study initiation: 2.18-3.26 g
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Undiluted - Duration of treatment / exposure:
- No wash: The eyes of six animals were not washed out after instillation of the test material.
Washout: The eyes of three animals were washed out 4 seconds after instillation of the test material, with distilled water for approximately 10 seconds or until all test material was removed from the eye. - Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- No wash: six animals
Washout: three animals - Details on study design:
- PRETREATMENT
The eyes of each rabbit were examined with sodium fluorescein and an ultraviolet lamp (prior to instillation of the test material) and only those rabbits whose eyes were free of irritation and corneal lesions were used.
REMOVAL OF TEST SUBSTANCE
- No wash: The eyes of six animals were not washed out after instillation of the test material.
- Washout: The eyes of three animals were washed out 4 seconds after instillation of the test material, with distilled water for approximately 10 seconds or until all test material was removed from the eye.
SCORING SYSTEM: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no wash out
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: no wash out
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: no wash out
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no wash out
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: wash out
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: wash out
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: wash out
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: wash out
- Irritant / corrosive response data:
- One animal in the 4-second washout group of the original study was observed to have corneal damage after 72 h. This finding was thought to be an artifact, as even the no washout group demonstrated absolutely no corneal damage. The 4 second washout group was repeated and no corneal damage was observed.
No wash out: Conjunctival effects were observed in three animals. This effect cleared in one animal during the 48 h reading and two animals cleared during the 7-day observation period.
Wash out: No ocular reactions were observed. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Eye irritation response data for each animal at each observation time
Score at time point |
Cornea |
Iris (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
Washout |
||||||
24 h (Day 1) |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
48 h (Day 2) |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
72 h (Day 3) |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Day 7 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Mean individual score 24, 48 and 72 h |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
0 / 0 / 0 |
Reversibility |
- |
- |
- |
- |
- |
- |
No wash |
||||||
24 h (Day 1) |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
2 / 0 / 1 / 0 / 0 / 1 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
48 h (Day 2) |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
2 / 0 / 1 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
72 h (Day 3) |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
1 / 0 / 1 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
Day 7 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
Mean individual score 24, 48 and 72 h |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
1.67 / 0 / 1.00 / 0 / 0 / 0.33 |
0 / 0 / 0 / 0 / 0 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
Reversibility |
- |
- |
- |
fully reversible within: 7 days |
- |
- |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information cannot be evaluated Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test material induced mild irritation being reversible within 7 days. Therefore, the test material is not classified as irritant to the eyes.
- Executive summary:
In an eye irritation study, 0.1 mL of undiluted test material was instilled into one eye of 9 New Zealand white rabbits while the untreated eye remained untreated and served as control. In Group 1, the eyes of six animals were not washed out after instillation of the test material. In Group 2, the eyes of three animals were washed out 4 seconds after instillation of the test material, with distilled water for approximately 10 seconds or until all test material was removed from the eye. Animals were observed at 24, 48 and 72 h after instillation of test material and then on Days 7. The reactions in the conjunctivae (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale.
One animal in the 4-second washout group of the original study was observed to have corneal damage after 72 h. This finding was thought to be an artifact, as even the no washout group demonstrated absolutely no corneal damage. The 4 second washout group was repeated and no corneal damage was observed.
Conjunctival effects (redness) were observed in three animals of the unwashed group. Those conjunctival redness, calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, were below the limit of classification (1.67 / 1 / 0.33 ≤ 2), cleared in one animal during the 48 h reading and in the two other animals during the 7-day observation period.
Under the test conditions, the test material is not classified as irritating to the eyes according to the annex VI of the Regulation EC No. 1272/2008 (CLP).
Although some details on test animals and experimental conditions were missing, this study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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