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EC number: 939-581-9 | CAS number: 1471314-81-4
- 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:
- weight of evidence
- Study period:
- 2006-03-07 - 2006-04-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-C12-18-(even numbered)-alkylamido-N,N-dimethylpropan-1-amino oxide
- EC Number:
- 939-581-9
- Cas Number:
- 1471314-81-4
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- 3-C12-18-(even numbered)-alkylamido-N,N-dimethylpropan-1-amino oxide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Name: OXIDET L-75
- Analytical purity: 30%
- Lot/batch No.: Pha007.1168
- Storage condition of test material: 20 ± 5 ºC and in the dark
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Granja Cunícola San Bernardo, S.L. (Tulebras, Navarra, Spain)
- Age at study initiation: 10-13 weeks old
- Weight at study initiation: 2.4-3.0 kg
- Housing: The animals were housed individually in stainless steel cages with a grille floor placed on racks.
- Diet (e.g. ad libitum): standard rabbit diet (SAFE 112C; Batches: 50602 and 51114), ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-25 ºC
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12 hours of light nad 12 hours of darkness every 24 hours.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 60 minutes, 24, 48, 72 hours, 7 days and 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the remains of the test item were removed with distilled water.
- Time after start of exposure: 4 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.78
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- No data
- Other effects:
- A loss of 30 grams in body weight was recorded between the day of administration and the 24 hours following it in the first rabbit administered, as was a loss of 110 grams in body weight between 48 and 72 hours after the administration. A loss of 70 grams in body weight was recorded in another animal between 72 hours and 7 days after the administration, and a loss of 10 grams between the day of administration and the 24 hours afterwards in the case of the remaining animal. However, a posterior recovery of the weight was observed in all the animals.
The behaviour and physical state of the rabbits was normal throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The means of the erythema and edema evaluation 24, 48 and 72 hours after removing the patch in the animals after a 4-hour exposure to the test item, were 2.11 (erythema) and 0.78 (edema). Only one animal showed a mean score (24-72 h) greater than 2.3. Based on the CLP classification criteria, the test material should not be classified for skin irritation.
- Executive summary:
The degree of primary dermal irritation caused by the test item was determined after application to the shaven skin of 3 rabbits. The study was carried out according to OECD guideline 404 and EU method B.4. Initially one animal was used, and 3 semiocclusive patches were applied sequentially during 3 minutes, 1 and 4 hours, respectively. A confirmation assay was then sequentially performed, applying a patch with the test item during 4 hours in another two animals. The means of the erythema and edema evaluations at 24, 48 and 72 hours after removing the patch in the animals after a 4 -hour exposure to the test item were 2.11 (erythema) and 0.78 (edema).
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