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EC number: 256-974-4 | CAS number: 51115-67-4
- 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:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. Code of Federal Regulation, Title 16, Section 1500.42
- Version / remarks:
- The Consumer Product Safety Commission of the U.S.A.
- Principles of method if other than guideline:
- - Principle of test:
test for eye irritants
- Short description of test conditions:
Animal facilities for such procedures shall be so designed and maintained as to exclude sawdust, wood chips, or other extraneous materials that might produce eye irritation. Both eyes of each animal in the test group shall be examined before testing, and only those animals without eye defects or irritation shall be used. The test material is placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance is dropped. The lids are then gently held together for one second and the animal is released. The other eye, remaining untreated, serves as a control.
- Parameters analysed / observed:
An animal shall be considered as exhibiting a positive reaction if the test substance produces at any of the readings ulceration of the cornea (other than a fine stippling), or opacity of the cornea (other than a slight dulling of the normal lustre), or inflammation of the iris (other than a slight deepening of the folds
(or rugae) or a slight circumcorneal injection of the blood vessels), or if such substance produces in the conjunctive (excluding the cornea and iris) an obvious swelling with partial eversion of the lids or a diffuse crimson-red with individual vessels not easily discemible.
The eyes are examined and the grade of ocular reaction is recorded at 24, 48 and 72 hours. Reading of reaction is facilitated by use of a binocular loupe, hand slit-lamp, or other expert means.
The test shall be considered positive, if four or more of the animals in the test group exhibit a positive reaction. If only one animal exhibits a positive reaction, the test shall be regarded as negative. If two or three animals exhibit a positive reaction, the test is repeated using a different group of six animals.
The second test shall be considered positive if three or more of the animals exhibit a positive reaction. If only one or two animals in the second test exhibit a positive reaction, the test shall be repeated with a different group of six animals. Should a third test be needed, the substance will be regarded as an irritant if any animal exhibits a positive response. - GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-isopropyl-N,2,3-trimethylbutyramide
- EC Number:
- 256-974-4
- EC Name:
- 2-isopropyl-N,2,3-trimethylbutyramide
- Cas Number:
- 51115-67-4
- Molecular formula:
- C10H21NO
- IUPAC Name:
- 2-isopropyl-N,2,3-trimethylbutyramide
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- test material: WS-23
Test animals / tissue source
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:albino rabbits
Test system
- Vehicle:
- other: 1% ethyl alcohol
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): 0.1%
VEHICLE
- Concentration (if solution): 1% ethanol - Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: not
SCORING SYSTEM: grades from ocular lesion From: "Illustrated Guide for Grading Eye Irritation by Hazardous Substances" U.S. Department of Health, Education and Welfare, Food and Drug Administration Washington, D. C. 20204
TOOL USED TO ASSESS SCORE: hand-slit lamp, binocular loupe
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- > 0 - <= 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: not irritating
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness and chemosis
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008
- Remarks:
- EU criteria used for interpretation of results
- Conclusions:
- WS-23 as a 0.1% solution in 1% ethyl alcohol gave a negative response for eye irritation.
- Executive summary:
In this study, 0.1 mL of the test item, WS-23 (0. 1% solution in 1 % of ethyl alcohol), was applied into one eye of each animal. In total 6 rabbits were used in this testing. The lids of animals were gently held together for approximately one second. The other eye, remaining untreated, serves as a control. WS-23 was not washed from the eye during the observation period of 7 days.
One animal gave a positive reaction. A diffuse crimson red colouration of the conjunctivae was observed in this animal two days after instillation. Temporary mild conjunctival inflammation was observed in four other animals. One animal did not show any observable response to the treatment throughout the 7 days observation period.
Based on these results, it was concluded that WS 23 (0.1% solution in 1% ethyl alcohol) gave a negative response for eye irritation, according to the definition given in the Code of Federal Regulations as well as according to OECD TG 405.
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