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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1976
- 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.A. Code of Federal Regulations, Title 16, Section 1500.41
- Version / remarks:
- the procedure employed was that prescribed by the Consumer Product Safety Commission of the U.S.A. Code of Federal Regulations, Title 16, Section 1500.41
- Principles of method if other than guideline:
- - Principle of test: Primary irritation to the skin is measured by a patch-test technique on the abraded and intact skin of the albino rabbit, clipped free of hair.
- Short description of test conditions: Six rabbits are used in abraded and intact skin tests. Introduce under a square patch, such as surgical gauze measuring 1 inch by 1 inch and two single layers thick, 0.5 milliliter (in the case of liquids) or 0.5 gram (in the case of solids and semisolids) of the test substance. Dissolve solids in an appropriate solvent and apply the solution as for liquids. The animals are immobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material, such as rubberized cloth, for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours of exposure, the patches are removed and the resulting reactions are evaluated on the basis of the designated values.
- Parameters analysed / observed: erythema and eschar formation, oedema formation - 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
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- test material: WS 23, 0.1 % solution in 1% ethyl alcohol.
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- albino rabbits
Test system
- Type of coverage:
- other: patch-test technique
- Preparation of test site:
- other: the abraded and intact skin of the albino rabbit, clipped free of hair
- Vehicle:
- other: ethyl alcohol
- Remarks:
- 1%
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- WS23, 0.1% solution in 1% ethyl alcohol.
VEHICLE
-no information available
NEGATIVE CONTROL
-no information available
POSITIVE CONTROL
- no information available - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 and 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: a square patch, such as surgical gauze measuring 1 inch by 1 inch and two single layers thick, 0.5 milliliter of the test substance.
- % coverage: 100% (the entire trunk of the animal is wrapped)
- Type of wrap if used: an impervious material, such as rubberized cloth, for the 24-hour period of exposure.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
OBSERVATION TIME POINTS
- 24 and 72 hours
SCORING SYSTEM:
- Method of calculation: GRADING OF SKIN REACTIONS (according to Code of Federal Regulations, Title 16, Section 1500.41. and OECD TG 404).
The "value" recorded for each reading (24 and 72 hours) is the average value of the six animals subject to this test.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- other: mean of animals
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- other: mean of animals
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: no indication of irritation
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- other: mean of animals
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Remarks on result:
- other: no edema observed
- Remarks:
- only 24 and 72 hours reading
- Irritation parameter:
- erythema score
- Basis:
- other: mean of animals
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Remarks on result:
- other: no erythema observed
- Remarks:
- only 24 and 72 hours reading
Any other information on results incl. tables
GRADING OF SKIN REACTIONS (according to Code of Federal Regulations, Title 16, Section 1500.41. and OECD TG 404):
Evaluation of skin reactions Erythema and eschar formation |
value |
No erythema |
0 |
Very slight erythema (barely perceptible) |
1 |
Well defined erythema |
2 |
Moderate to severe erythema |
3 |
Severe erythema (beef redness) to slight eschar information (injures in depth) |
4 |
Evaluation of skin reactions Oedema formation |
value |
No oedema |
0 |
Very slight oedema (barely perceptible) |
1 |
Slight oedema (edges of area well defined by definite raising) |
2 |
Moderate oedema (raised approximately 1 mm) |
3 |
Severe oedema (raised more than 1 mm and extending beyond area of exposure) |
4 |
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 is not considered to be an irritant to rabbit skin.
- Executive summary:
In this key study, performed according to the procedure employed by the Consumer Product Safety Commission of the U.S.A., US Code of Federal Regulations, Title 16, Section 1500.41, the primary irritation to the skin was measured by a patch test technique in six albino rabbits.
The obtained results of the reading were also evaluated in accordance to the OECD TG 404.
WS-23 (0.1% solution in 1% ethanol) was applied to one intact and one abraded skin site on the clipped dorsum of rabbits.
After 24 hours of exposure, the patches were removed and the skin reactions, i.e. erythema and eschar formation as well as edema formation,
were evaluated.
None of the treated animals showed any observable response throughout the 72 hours observation period.
It was concluded based on the results, that WS-23 as a 0.1% solution in 1% ethyl alcohol was not an irritant to rabbit skin.
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