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EC number: 254-384-1 | CAS number: 39255-32-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 September to 05 September 1986.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl 2-methylpentanoate
- Cas Number:
- 39255-32-8
- IUPAC Name:
- Ethyl 2-methylpentanoate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Manzanate, DL 4979/F4-24.
- Physical state: clear, colourless, slightly viscous liquid
- Other:
- A sample of the test material was received from the sponsor on August 14, 1986.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: New Zealand White albino rabbits
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: obtained from ENKI-Konijnenfarm, Someren, the Netherlands
- Age at study initiation: young adult
- Weight at study initiation: body weight range 2500-3500 g
- Housing: The animals were identified by earmarking, and housed individually in suspended, galvanized cages, fitted with wire-mesh floor and front.
- Diet (e.g. ad libitum): A standard laboratory rabbit diet was provided ad libitum.
- Water (e.g. ad libitum): tap water was provided ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): at least 40% (relative humidity)
- Air changes (per hr): ventilation c. 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Experimental design:
- Both eyes of each rabbit provisionally selected were examined within 24 hours before testing. Three animals without observable eye effects were used.
- One tenth of a millilitre of the undiluted test substance was allowed to fall on the everted lower lid of one eye of each rabbit. After administration the upper and lower eye lid were carefully closed and subsequently held together for about one second before releasing, to prevent loss of material. The other eye remaining untreated, served as a control. The eyes were not washed out following administration and the animals were released immediately.
- Ocular reactions were judged using the scoring scale which is given in an appendix at the end of this report (see page 10 of attached report).
- Eye effects were examined after one hour, 24, 48 and 72 hours, or until the eye effects had cleared completely.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 4020
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 4022
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 4023
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 4020
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 4022
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 4023
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 4020
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 4022
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 4023
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 4020
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 4022
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 4023
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
- After one hour and after 24 hours, the eye effects observed in all (three) rabbits consisted of slight redness and slight swelling of the conjunctivae.
- After 48 hours, all eye effect had cleared completely.
Table 1. Individual Scores Awarded to the Ocular Lesions Elicited by Manzanate
Rabbit number |
Cornea opacity |
Iris |
Conjunctivae |
|
Redness |
Chemosis |
|||
|
|
|
After one hour |
|
4020 |
0 |
0 |
1 |
1 |
4022 |
0 |
0 |
1 |
1 |
4023 |
0 |
0 |
1 |
1 |
|
|
|
After 24 hours |
|
4020 |
0 |
0 |
1 |
1 |
4022 |
0 |
0 |
1 |
1 |
4023 |
0 |
0 |
1 |
1 |
|
|
|
After 48 hours |
|
4020 |
0 |
0 |
0 |
0 |
4022 |
0 |
0 |
0 |
0 |
4023 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of the results obtained it is concluded that, according to the EEC-standards (as published in the Official Journal of the European Communities, L 257, Volume 26, 16 September 1984), the undiluted test substance Manzanate is not irritating or corrosive to eyes.
- Executive summary:
1. A sample of Manzanate was examined undiluted for acute eye irritating/corrosive properties in an experiment with three albino rabbits.
2. The test substance caused slight eye effects in all (three) rabbits. After 48 hours, all eye effects had cleared completely.
3. On the basis of the results obtained it was concluded that, according to the EEC-standards, the undiluted test substance Manzanate is not irritating or corrosive to eyes.
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