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EC number: 264-438-6 | CAS number: 63738-22-7
- 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:
- supporting study
- Study period:
- 26 Jun 1978 to 3 Jul 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- exposure duration of 24 hours instead of 4 hours/ occlusive coverage/ dilutions of the substance tested
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N,N,N',N'-tetrakis(2,3-epoxypropyl)-m-xylene-α,α'-diamine
- EC Number:
- 264-438-6
- EC Name:
- N,N,N',N'-tetrakis(2,3-epoxypropyl)-m-xylene-α,α'-diamine
- Cas Number:
- 63738-22-7
- Molecular formula:
- C20H28N2O4
- IUPAC Name:
- N,N,N',N'-tetrakis(2,3-epoxypropyl)-m-xylene-α,α'-diamine
1
- Specific details on test material used for the study:
- Name cited in study report: PGA-X
Lot No: 80524
Appearance: colorless high viscous liquid
Test animals
- Species:
- rabbit
- Strain:
- other: albino rabbits of Japanese native strain
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ichikawaya Limited
- Weight at study initiation: 2.6 to 3 kg
- Housing: The animals were housed individually in a conventional aluminum rabbit cage
- Diet: The animals were allowed free access to complete pelleted rabbit diet (Diet RC-4, Oriental Yeast Co.)
- Water: The animals were allowed free access to automatic watering.
- Acclimation period: 7 day observation period. During this period, all animals were inspected for sigins of disease and skin condition
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 to 24
- Humidity (%): 50 to 60
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- other: acetone
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- - 0.15 mL of each concentration (and vehicle control) was individually applied.
- concentrations: 0.1, 0.4, 1.6, 6.4, and 25.6% v/v - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- six males
- Details on study design:
- TEST SITE
- Preparation of test site: Twenty-four hours before the intended application, the fur were clipped from the dorsal and blank regions of all animals by electric clippers.
- Type of wrap: Application was done on the intact skin of the rabbits with test-plaster (Bayer-Dorf) as a patch. 0.15 mL of five test solutions and acetone which was the vehicle control were applied individually. The patches were secured in place by 1.2 x 4 cm adhesive tape (Eratex). The entire trunk of the animal was wrapped with an impervious polystyrene film and covered with cloth for the 24-hours of exposure. The cloth material aids to maintain the test patches in position.
REMOVAL OF TEST SUBSTANCE
After 24 hours of exposure, the patches were removed and applied areas were rinsed with 200 mL tepid water. The plastic collar was fitted on the neck of the rabbit to prevent for the rabbit to access by mouth and to maintain the applied area during the observation period.
OBSERVATION TIME POINTS
Three hours after exposure, the first readings for the resulted reactions were made and assigned to the 24 hour data points. The second reading was done 74 hours after application. Score were additionally determined at 48 hours and 7 days.
SCORING SYSTEM:
- Erythema and eschar formation, edema formation on applied areas were evaluated by the procedure described by Draize.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3, #4, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 0.1% concentration
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 0.1% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 0.4% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal: #3 and #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- other: 0.4% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 0.4% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 0.4% concentration
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4, #5 and #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 0.4% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1.6% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #2
- Time point:
- other: 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 1.6% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal: #3 , #4 and #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1.6% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1.6% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: 48 and 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 1.6% concentration
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4 and #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 1.6% concentration
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 1.6% concentration
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- other: 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 1.6% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #4 and #5
- Time point:
- 24/48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 48 and 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #4, #5 and #6
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- edema score
- Basis:
- animal: #3, #4, #5 and #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #3 and #4
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- edema score
- Basis:
- animal: #2, #5 and #6
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4, #5 and #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 6.4% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #3 and #4
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 25.6% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 25.6% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 25.6% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal: #1 and #3
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 25.6% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal: #2, #5 and #6
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 26.5% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 25.6% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2 and #4
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 25.6% concentration
- Irritation parameter:
- erythema score
- Basis:
- animal: #2, #5 and #6
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 25.6% concentration
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #4, #5 and #6
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 25.6% concentration
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 25.6% concentration
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #4
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: 25.6% concentration
- Irritation parameter:
- edema score
- Basis:
- animal: #2, #5 and #6
- Time point:
- other: 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 25.6% concentration
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 25.6% concentration
- Irritation parameter:
- edema score
- Basis:
- animal: #1 and #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 25.6% concentration
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: 25.6% concentration
- Irritant / corrosive response data:
- No irritation was observed for the regions treated with the vehicle control.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Since the diluted substance (at 25.6%) resulted in significant skin irritation, the test item was considered to be irritating to the skin.
- Executive summary:
In a study, comparable to OECD404, 0.15 mL of five different test substance dilutions were applied on distinct regions of the intact skin of six male albino rabbits of Japanese native strain under occlusive conditions. The applied concentrations were 0.1, 0.4, 1.6, 6.4 and 25.6% dissolved in acetone. A vehicle control was taken along. Animals were exposed for 24 hours after which the substance was removed with 200 mL tepid water. Application of the vehicle was included as control. Erythema and edema were scored according to the Draize scoring system 24, 48, 72 hours and 7 days after exposure. Irritating effects were observed mostly at the sites treated with 6.4 and 25.6% test substance. Erythema scores of 1 to 3 were obtained in in the 6.4% dose group after 24 hours, but the effects were reversible within 7 days, except for one animal. Edema was scored between 0 to 2 after 24 hours and was fully reversible. After application of 25.6% the erythema score was 2 to 3 after 24 and 48 hours and 1 or 2 after 72 hours. The effects were fully reversible within 7 days in half of the animals. The edema scores were 0 or 1 and fully reversible in the 7 day observation period. For one animal an edema score of 2 was obtained at the 24 and 48 timepoints, these effects were reversible as well. Based on the effects observed on the intact skin, the diluted substance at 25.6% has to be considered as irritating to the skin.
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