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EC number: 206-080-5 | CAS number: 299-42-3
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, similar to guideline study, minor restrictions in design and/or reporting buth otherwise adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- , occlusive conditions
- GLP compliance:
- no
Test material
- Reference substance name:
- 299-43-3
- IUPAC Name:
- 299-43-3
- Details on test material:
- - Name of test material (as cited in study report): (-)-ephedrin, wasserhaltig
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gaukler 6050 Offenbach/Main
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: 1 animal per cage, stainless steel cage with wire mesh flooring, floor space: 40 cm x 51 cm, no bedding in cages, sawdust in the waste trays.
- Diet: 130 g per animal per day, Ovator Solikanin 4MM; Muskator-Werke 4000 Dusseldorf
- Water: 250 mL per animal, demineralized water on workdays, and 250 mL per animal tap water on free days
- Acclimation period: ca. 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -26
- Humidity (%): 50 - 80
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- other: untreated skin of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: the test patch is covered with an about 0.5 mm layer of the suspension (about 0.5 g)
- Concentration: 50% aqueous solution - Duration of treatment / exposure:
- - Group 1: 3 min
- Group 2: 1 hour - Observation period:
- 8 days
- Number of animals:
- - Group 1: 2
- Group 2: 4 - Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm of upper third part of the back
REMOVAL OF TEST SUBSTANCE
- Washing with lutrol and lutrol/water (1:1)
- Time after start of exposure: after 3 min or 1 hour
SCORING SYSTEM:
- According Draize J.H. et al. (1959)
- Scoring performed 15-30 min, 24, 48, and 8 days after removal of the test substance
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 - 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 3 min exposure
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 - 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 3 min exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 - 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24 - 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24 - 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24 - 48 h
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 1 h exposure: No observation at timepoint 24 and 48 hours because of substance-related coloring of the skin
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24 - 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 24 - 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 1 h exposure
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 24 - 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 8 days
- Remarks on result:
- other: 1 h exposure
- Irritant / corrosive response data:
- In 3 out of 4 animals redness and edema was observed 24 and 48 hours after exposure. In 2 out of 4 animals haemorrhagic crustae were visible 24 hours after exposure. In 1 animal necrosis was also observed 24 and 48 hours after exposure. Necorisis was observed in all animals 8 days after exposure.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the test, the substance is considered to be corrosive to the skin after an exposure period of one hour.
- Executive summary:
The potential to cause acute dermal irritation or corrosion was assessed in a similar to OECD 404 guideline study by a single topical application of 0.5 g for 3 minutes or 1 hour to the intact skin of 2 or 4 Vienna White rabbits, respectively, using a patch of 2.5 cm x 2.5 cm, covered with occlusive dressing. After removal of the patch, the application area was washed off with lutrol and lutrol/water (1:1). The cutaneous reactions were assessed immediately after removal of the patch and approximately 24 and 48 hours, and 8 days after removal. In animals exposed for 3 min no effects were observed. In 3 out of 4 animals exposed for 1 hour redness and edema was observed 24 and 48 hours after exposure. Haemorrhagic crustae were also visible in 2 out of 4 animals at the 24 hours after exposure. Necrosis was observed in all animals 8 days after exposure. It was concluded that the test substance was corrosive.
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