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EC number: 203-640-0 | CAS number: 109-02-4
- 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:
- 1990-08-22 - 1990-09-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Well documented GLP study performed according to a method similar to OECD Guideline 404 with the following deviations: an occlusive dressing was used (instead of semi-occlusive). Furthermore, next to application of the test substance on intact shaved skin, also abraded skin was tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- occlusive dressing used (instead of semi-occlusive); abraded skin was tested
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-methylmorpholine
- EC Number:
- 203-640-0
- EC Name:
- 4-methylmorpholine
- Cas Number:
- 109-02-4
- Molecular formula:
- C5H11NO
- IUPAC Name:
- 4-methylmorpholine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): 6398-24-20, Project #90-005
- Substance type: clear, colorless liquid
- Physical state: liquid
- Lot No.: 90-005
- Purity: responsibility of the sponsor
- Stability under test conditions: There was no apparent change in the physical state of the test article during administration.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hare-Marland, Hewitt, NJ, USA
- Age at study initiation: adult animals
- Weight at study initiation: males 2129-2507 g (mean 2351 g); females 2170-2633 g (mean 2468 g)
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 30-70%
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and intact shaved skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/site - Duration of treatment / exposure:
- The test substance was kept in contact with the skin on the upper dorsal site (intact) for four hours and at the lower dorsal sites (intact and abraded) for twenty four hours.
- Observation period:
- Dermal irritation was scored at 30-60 minutes, 24, 48 and 72 hours and on Days 4 through 14 after patch removal. Dermal irritation of the lower dorsal sites (intact and abraded) were scored at 24, 48 and 72 hours and on Days 4 through 14 after application of the test material.
- Number of animals:
- 6 (3 males and 3 females)
- Details on study design:
- TEST SITE
- Area of exposure: one intact site on the upper dorsal trunk and at two sites, one intact and one abraded, on the lower dorsal trunk of the animal.
- Type of wrap if used: All application sites were clipped free of hair. The abraded site was prepared using a burred needle; the abrasion penetrated the stratum corneum but not the derma. Following the application of the test material, gauze patches were applied to each of the sites then wrapped with a rubber dam and an elastic bandage to retard evaporation.
REMOVAL OF TEST SUBSTANCE
At the end of each exposure period, the sites were wiped with water and gauze and observed for erythema and edema.
SCORING SYSTEM: Draize evaluation of dermal irritation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: application on intact shaved skin (upper dorsal area)
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: application on intact shaved skin (upper dorsal area)
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: application on intact shaved skin (upper dorsal area)
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: application on intact shaved skin (upper dorsal area)
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: application on intact shaved skin (upper dorsal area)
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: application on intact shaved skin (upper dorsal area)
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: application on intact shaved skin (upper dorsal area)
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: application on intact shaved skin (upper dorsal area)
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: application on intact shaved skin (upper dorsal area)
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: application on intact shaved skin (upper dorsal area)
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: application on intact shaved skin (upper dorsal area)
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: application on intact shaved skin (upper dorsal area)
- Irritant / corrosive response data:
- Moderate to severe erythema and edema were observed at the 30-60 minute observation period on the upper dorsal site. Severe erythema and edema were observed at the 24, 48 and 72 hours and on days 4 through 14 on the upper dorsal site. Severe erythema and edema were observed at the 24, 48 and 72 hours and on days 4 through 14 on the lower dorsal sites. Necrosis of the skin was observed at each application site at the 24, 48 and 72 hours and on days 4 through 14 observation periods at each application site. Sloughing of the skin at the application site was observed at the day 14 observation period on the upper dorsal site and at the day 13 and 14 observation periods at the lower dorsal sites. The study was terminated following the day 14 observation period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Based on the test results and according to the criteria of the CLP Regulation, the substance is classified as category 1 corrosive.
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