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EC number: 204-590-2 | CAS number: 123-00-2
- 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:
- From 3 October 2001 to 16 October 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-morpholinopropylamine
- EC Number:
- 204-590-2
- EC Name:
- 3-morpholinopropylamine
- Cas Number:
- 123-00-2
- Molecular formula:
- C7H16N2O
- IUPAC Name:
- 3-morpholin-4-ylpropan-1-amine
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: no data
- Expiration date of the lot/batch: no data
- Purity test date: no data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature (10-30°C)
- Stability under test conditions: no data
- Solubility and stability of the test substance in the solvent/vehicle: not applicable, test item was tested neat
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: the test item was dosed neat as received from the sponsor.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: 3 male and 3 female New Zealand White rabbits - HM (NZW) fBR; Hare Marland
- Age at study initiation: 18-19 weeks
- Weight at study initiation: 3.3-3.4 kilograms
- Housing: individually, in compliance with USDA guidelines.
- Diet (e.g. ad libitum): all animals had access to Teklad Certified Rabbit Diet or equivalent
- Water (e.g. ad libitum): ad libitum
- Acclimation period: a minimum of 5 days during which each animal was observed at least once daily for any abnormalities or for the development of infectious disease.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 21°C
- Humidity (%): 30 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours artifical light/12 hours dark
IN-LIFE DATES: From: 2001-10-03 To: 2001-10-16
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/site on the clipped dorsal trunk of each animal - Duration of treatment / exposure:
- 3 minutes, 60 minutes and 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: no data
- Type of wrap if used: the trunk of each animal was wrapped with an elastic bandage and non-irritating tape to prevent animal access to the test sites and possible ingestion/inhalation of the test article.
- Within 24 hours before the test, the fur was removed from the dorsal area of the trunk of each rabbit, being careful to avoid abrading the skin. The test article was administered once to each of three sites on the clipped dorsal trunk of each animal. For all sites the test article was applied directly to the skin and covered with a gauze patch. The patch was held in contact wih the skin with a semi-occlusive dressing (rubber sheeting).
- The test item was also administered to one intact site of the upper left dorsal trunk of the animal (3-minute exposure).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed, without altering the existing response or the integrity of the epidermis. After the 3-min exposure time, the site was unwrapped and washed with mineral oil and gauze.
- Time after start of exposure: 3 minutes, 60 minutes or 4 hours
OBSERVATION TIME POINTS
- erythema, edema and necrosis: immediately after patch removal and then daily through day 14. The 3-min exposure site was also scored at 55-60 minutes after patch removal. The 4-hour exposure site was scored at 24, 48 and 72 hours (+/- 1 hour).
SCORING SYSTEM:
- according to Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- necrosis
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- necrosis
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- necrosis and blanching
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 14 days
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicale
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- 3 min exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritation parameter:
- erythema score
- Remarks:
- 3 min exposure
- Basis:
- mean
- Remarks:
- animal # 2, 3, 4, 5 & 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Remarks:
- 3 min exposure
- Basis:
- mean
- Remarks:
- all 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Remarks:
- 1 h exposure
- Basis:
- mean
- Remarks:
- animal # 2 & 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Remarks:
- 1 h exposure
- Basis:
- mean
- Remarks:
- animal # 3 & 5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- positive indication of irritation
- Remarks:
- necrosis and blanching
- Irritation parameter:
- erythema score
- Remarks:
- 1 h exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- 1 h exposure
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Remarks:
- 1 h exposure
- Basis:
- mean
- Remarks:
- animal # 3 & 5
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal # 2, 4 & 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Remarks:
- 1 h exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Irritant / corrosive response data:
- - 3- minute exposure: well-defined erythema and no edema, no other dermal signs noted
- 60-minute exposure: severe erythema and severe edema. Necrosis, fissuring, sloughing, flaking and blanching were also noted.
- 4-hour exposure: severe erythema and severe edema. Necrosis, fissuring, sloughing, flaking and blanching were also noted. - Other effects:
- The test article was classified as non-corrosive using Corrositex (r) System technique and the study procceeded with testing in the animal model.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- The test article was found to be a sever irritant. The test article was also found to be corrosive according to DOT Classification (Packing Group II). The primary irritation index was calculated as follows:
Exposure OECD PII OSHA PII
4 hour 5.1 5.4
Based on the criteria of the CLP regulation (EC) No. 1272/2008, the test item should be classified as category 1 (corrosive), subcategory 1B (Corrosive responses in at least one animal following exposure > 3 min and ≤ 1 h and observations ≤ 14 days).
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