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EC number: 218-059-8 | CAS number: 2044-64-6
- 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: GLP study conducted in accordance with international guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2012
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:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N-dimethyl-3-oxobutyramide
- EC Number:
- 218-059-8
- EC Name:
- N,N-dimethyl-3-oxobutyramide
- Cas Number:
- 2044-64-6
- Molecular formula:
- C6H11NO2
- IUPAC Name:
- N,N-dimethyl-3-oxobutyramide
- Test material form:
- other: Colourless to yellow
- Details on test material:
- Name of test material (as cited in study report): LZ705
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species and strain: New Zealand white rabbit
Hygienic level during the study: good conventional
Justification of strain: The New Zealand white rabbit is one of the standard animals in acute eye irritation study.
Number of animal: 3 males
Age of animals: adult rabbits
Body weight range at the beginning of the study: 2960 - 3020 g
Body weight range at the end of the study: 3044 - 3109 g
Date of receipt: October 04, 2012
Acclimatisation time: 5 days
Housing: Animal was housed individually in metal cage.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 20 ± 3 °C
Relative humidity: 30-70 %
The animals received Rabbit fattening mixed diet produced by YAQ-TÁP Kft., Nyíregyháza (Tokaji út 22), Hungary, ad libitum.
Animals received tap water from watering bottles ad libitum.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 ml of the test item LZ705 was used for the study in pure state, in a single dose. The absorption of the test item was not determined.
- Duration of treatment / exposure:
- The eyes of the test animals were not washed out after the application of test item.
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after the application.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Three male animals in acceptable health condition were selected for the test. Care was taken to select only those animals that had a normal eye condition, any with ocular lesions were rejected.
In the first step an initial test was performed using one animal. The test item was poured into the conjunctival sac of the left eye. The eyelids were held closed gently for several seconds to prevent the loss of the test item. The contralateral eye served as control. Immediately after the administration of
the test item, an assessment of the initial pain reaction was made.
After consideration of the ocular responses produced in the first animal, two additional animals were treated. Before the administration the treated
eyes of animals were not anaesthetised, because the score of initial pain reaction was 3 in the first animal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0.33
- Max. score:
- 0.66
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0.33
- Max. score:
- 0.33
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- One hour and 24 hours after the treatment some hyperemic blood vessels (score 1) were occurred in all animals. The swelling was different from normal (score 1) in all animals. Discharge with moistening of the lids and hairs just adjacent to lids (score 2) was observed in animal No.: 1746 and the
amount of discharge was different from normal (score 1) in two animals (No.: 1750, 1745).
48 hours after the treatment some hyperemic blood vessels (score 1) were found in animal No.: 1745. Two animals (No.: 1750, 1746) became free of
symptoms.
72 hours after the treatment all animals were free of eye irritation symptoms. - Other effects:
- General state and the behaviour of animals were normal throughout the study period. There were no notable body weight changes during the contact and observation period.
Any other information on results incl. tables
Mean values of eye irritation scores for EU classification (24, 48 and 72 hours reading)
Species: NZW Rabbit
Dose: 0.1 ml
Sex: Male
Start of Exposition: October 09, 2012
Test Item: LZ705
Animal Number |
Sex |
Cornea Opacity |
Iris |
Conjunctivae |
||
Redness |
Chemosis |
Discharge |
||||
1750 |
male |
0.00 |
0.00 |
0.33 |
0.33 |
0.33 |
1746 |
Male |
0.00 |
0.00 |
0.33 |
0.33 |
0.33 |
1745 |
Male |
0.00 |
0.00 |
0.66 |
0.33 |
0.33 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, test item LZ705 applied to the rabbits' eye mucosa, caused slight to moderate conjunctival irritant effects, fully reversible within
72 hours. According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
According to Regulation (EC) No. 1272/2008, the test item has not been classified into any category. - Executive summary:
The eye irritation study to the rabbit was performed in October 2012 according to OECD Guideline 405 and GLP. The test item LZ705 applied to the rabbits' eye mucosa, caused slight to moderate conjunctival irritant effects, fully reversible within 72 hours. According to the EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
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