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EC number: 203-299-8 | CAS number: 105-45-3
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Methyl acetoacetate
- EC Number:
- 203-299-8
- EC Name:
- Methyl acetoacetate
- Cas Number:
- 105-45-3
- Molecular formula:
- C5H8O3
- IUPAC Name:
- methyl 3-oxobutanoate
- Details on test material:
- - Name of test material (as cited in study report): Acetessigsäuremethylester (methyl acetoacetate),
- Substance number: 83/114
- Analytical purity: no data
- Expiration date of the lot/batch: April 1985
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, Offenbach am Main, Germany
- Age at study initiation: no data
- Weight at study initiation: Two females (mean weight, 2.92 kg) and one male (2.74 kg)
- Housing: single
- Diet (e.g. ad libitum): Ovator Solikanin 4 mm, Muskator-Werke, Duesseldorf, ca 130 g / animal / day
- Water (e.g. ad libitum): ca. 250 ml tap water / animal / day
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye of each animal remained untreated and 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:
- single treatment
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3 (1 male; 2 females)
- Details on study design:
- TREATMENT
- One tenth millilitre of the undiluted test substance was instilled into the conjunctival sac of the right eye lid of each rabbit.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was not washed out.
READINGS
Following application, readings of the eyes were performed at 1, 24, 48 and 72 hours after instillation and at 8 days after instillation. The rabbits were also observed for their general condition.
SCORING SYSTEM
- The assessment of the ocular lesions was based on the scoring of JH Draize, Appraisal of the saftey of chemicals in foods, drugs, and cosmetics. In dermal toxicity pp. 46-59, 1959.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days (score 1)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24, 48 and 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Findings after 1 hour: A slight corneal opacity was reported. The conjunctivae displayed noticeable to severe redness and swelling, with slight to noticeable lacrimation (all animals). In one animal the pupil of the rabbit was constricted.
Findings after 24 hours: Corneal opacity still persisted in all rabbits, and in one animal, it even had become more conspicuous than the 1-hour finding. The conjunctivae still displayed noticeable to severe redness; however, swelling had improved to slight degree in two animals. Slight to noticeable lacrimation was still seen in all animals. Ciliary injection of the iris was observed in all three rabbits. The rabbits had narrowed pupils; suppuration and scarring within the eyelid was reported for one animal.
Findings after 48 hours: Slight to severe corneal opacity still persisted seen in two of the three rabbits; in one rabbit, corneal opacity had disappeared. Slight to noticeable redness of the conjunctivae persisted in all animals. Swelling of a slight degree was noted in two animals; no edema was reported for the third animal. The incidence of lacrimation was similar to those reported at 24 hours. In two animals, ciliary injection had developed into iritis; the remaining rabbit still displayed ciliary injection within the iris. All the rabbits had narrowed pupils; scarring within the eyelid was seen in one rabbit, scarring with suppuration was seen in another animal.
Findings after 72 hours: With exception of ciliary injection, the treated eye of one rabbit had completely recovered at this time point. For the remaining two rabbits, incidence and severity of both corneal and iritic effects were similar to those reported at 48 hours. Conjunctivae redness persisted in one rabbit; conjunctival redness, edema, and lacrimation persisted in another rabbit. Both rabbits still had narrowed pupils and scarring of the eyelid without and with suppuration, respectively.
Findings after 8 days: After 8 days the treated eyes of two rabbits showed no more effects within the cornea, conjunctivae and iris; however, scarring of the eyelid was still present in one of these two animals. The third animal still displayed slight corneal opacity affecting less than 1/4 of the corneal surface, narrowed pupil and scarring of the eyelid. - Other effects:
- No other effects were observed.
Any other information on results incl. tables
Animal |
Reading |
Cornea |
Iris |
Conjunctiva |
|
Additional findings |
|
|
Opacity |
|
Redness |
Chemosis |
|
1 |
1 h |
1 |
1 |
3 |
2 |
constricted pupil |
2 |
1 h |
1 |
0 |
2 |
2 |
constricted pupil |
3 |
1 h |
1 |
0 |
3 |
3 |
constricted pupil |
1 |
24 h |
1 |
1 |
2 |
1 |
constricted pupil |
2 |
24 h |
1 |
1 |
2 |
1 |
constricted pupil |
3 |
24 h |
2 |
1 |
3 |
2 |
constricted pupil, ulceration, scarred retraction at the eyelid |
1 |
48 h |
1 |
2 |
2 |
1 |
constricted pupil, scarred retraction at the eyelid |
2 |
48 h |
0 |
1 |
1 |
0 |
constricted pupil |
3 |
48 h |
2 |
2 |
2 |
1 |
constricted pupil, ulceration, scarred retraction at the eyelid |
1 |
72 h |
1 |
2 |
2 |
0 |
constricted pupil |
2 |
72 h |
0 |
1 |
0 |
0 |
scarred retraction at the eyelid |
3 |
72 h |
2 |
2 |
2 |
1 |
constricted pupil, ulceration, scarred retraction at the eyelid |
1 |
8 d |
0 |
0 |
0 |
0 |
constricted pupil |
2 |
8 d |
0 |
0 |
0 |
0 |
|
3 |
8 d |
1 |
0 |
0 |
0 |
constricted pupil, ulceration |
mean animal 1 |
24 - 72 h |
1.00 |
1.67 |
2.00 |
0.67 |
|
mean animal 2 |
24 - 72 h |
0.33 |
1.00 |
1.00 |
0.33 |
|
mean animal 3 |
25 - 72 h |
2.00 |
1.67 |
2.33 |
1.33 |
|
mean |
24 - 72 h |
1.11 |
1.44 |
1.78 |
0.78 |
|
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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