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EC number: 248-211-9 | CAS number: 27076-30-8
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1993-03-30 to 1993-04-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study is an OECD 401 study under GLP and well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- ACMEO
- IUPAC Name:
- ACMEO
- Reference substance name:
- 3-[(2-hydroxyethyl)amino]propionamide
- EC Number:
- 248-211-9
- EC Name:
- 3-[(2-hydroxyethyl)amino]propionamide
- Cas Number:
- 27076-30-8
- Molecular formula:
- C5H12N2O2
- IUPAC Name:
- N~3~-(2-hydroxyethyl)-beta-alaninamide
- Test material form:
- other: colourless slightly viscous liquid
- Details on test material:
- - Name of test material (as cited in study report): ACMEO
- Physical state: colourless slightly viscous liquid
- Analytical purity: n.a.
- Lot/batch No.: 3S1005
- Storage condition of test material: +4°C
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: rabbjts were suppl ied by David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: n.a.
- Weight at study initiation: 2.50 - 2.86 kg
- Housing: animals were housed individual in suspended metal cages
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 21°C
- Humidity (%): 37 - 46 %
- Air changes (per hr): 15/ hr
- Photoperiod (hrs dark / hrs light): 12 hours dark/112 hours light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL of undiluted test substance
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm gauze patch
- % coverage: n.a.
- Type of wrap if used: To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material removed by gentle swabbing with cotton wool soaked in diethyl ether.
- Time after start of exposure: 4 hours after application the corset and patches were removed from each animal.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Remarks:
- male
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Very slight erythema was noted at all treated skin sites one hour after patch removal and at two treated skin sites at the 24- and 48-hour observations.
Very slight oedema was noted at one treated skin site at the 24 hour observation. All treated skin sites appeared normal at the 72-hour observation.
No corrosive effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this OECD 404 study in rabbits the test substance is not irritant to the skin.
- Executive summary:
ACMEO was tested for primary skin irritation according to OECD test guideline 404 in New Zealand White rabbits. The test substance was applied undiluted under semiocclusive conditions to the intact clipped skin for 4 hours. Thereafter, the wrapping was removed and the residual test material was removed by gently swabbing with cotton wool soaked in diethyether. Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to Draize. Very slight erythema was noted at all treated skin sites one hour after patch removal and at two treated skin sites at the 24- and 48-hour observations. Very slight oedema was noted at one treated skin site at the 24 hour observation. All treated skin sites appeared normal at the 72-hour observation. No corrosive effects were noted.
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