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1-(C12-C18 even numbered, C18 unsaturated)alkyl-1,4,5,6-tetrahydropyrimidin-2-aminium acetate and{[3-((C12-C18 even numbered, C18 unsaturated)alkylamino)propyl]amino}(imino)methanaminium acetate and[(3-{[ammonio(imino)methyl]amino}propyl)(C12-C18 even numbered, C18 unsaturated)alkylamino](imino)methanaminium diacetate
EC number: 939-650-3 | CAS number: -
- 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 / corrosion, other
- Remarks:
- At this time an In-vivo study was performed and therefore covers this endpoint.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD Guideline 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- C12-C16 (even numbered) alkyl-1,4,5,6-tetrahydropyrimidin-2-aminium acetate and {[3-(C12-C16 (even numbered)alkylamino)propyl]amino}(imino)methanaminium acetate and [(3-{[ammonio(imino)methyl]amino}propyl)-C12-C16 (even numbered)alkylamino](imino)methanaminium diacetate
- EC Number:
- 939-650-3
- Cas Number:
- 2770917-88-7
- IUPAC Name:
- C12-C16 (even numbered) alkyl-1,4,5,6-tetrahydropyrimidin-2-aminium acetate and {[3-(C12-C16 (even numbered)alkylamino)propyl]amino}(imino)methanaminium acetate and [(3-{[ammonio(imino)methyl]amino}propyl)-C12-C16 (even numbered)alkylamino](imino)methanaminium diacetate
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Hoechst AG, conventional breeding- Age at study initiation: 3 - 5 month- Weight at study initiation: 2.7 - 3.3 kg- Housing: individual in stainless steel cages- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20 +/- 3°C- Humidity (%): 50 +/- 20 %- Air changes (per hr): 15- Photoperiod (hrs dark / hrs light): 12 hour interval
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL of undiluted test item
- Duration of treatment / exposure:
- 1 hour respectively 4 hours
- Observation period:
- The evaluation was carried out 30 - 60 min and 24, 48 and 72 hours as well as 7, 14 and 21 days after the removal of the patch.
- Number of animals:
- 1 hour of exposure: 3 animals4 hours of exposure: 3 animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 1 hour exposure
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Remarks:
- 1 hour exposure
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Remarks:
- 1 hour exposure
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 0.67
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Remarks:
- 1 hour exposure
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Remarks:
- 1 hour exposure
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Remarks:
- 1 hour exposure
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 0.1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Remarks:
- 1 hour exposure
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24 / 48 7 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Remarks:
- 1 hour exposure
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 2.44
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- erythema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 days
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 0.67
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- 14 days
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72hours
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Remarks:
- 4 hour exposure
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24 / 48 / 72hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritant / corrosive response data:
- 4 hour exposure: Scare formation in one animal, no full revesibility in all animals after 21 days
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the test results of this study, the test material is considered to be corrosive to rabbit skin.
- Executive summary:
The registration substance was tested in a GLP conform study for skin irritation / corrosion according to OECD test guideline 404. For this 0.5 mL of undiluted test material was applied semi-occlusively for 1 hour or 4 hours to the shaved skin of three New Zealand White rabbits per exposure period. The skin then was examined 30 minutes, 1 hour, 24, 48 and 72 hours after removal of the dressing. Since effects were still present after 72 hours, additional readings were performed after 7, 14 (1 hour exposure group) and 21 days (4 hour exposure group).
Results for the 60 minute exposure period (3 animals): From 30 minutes to 14 days after patch removal, the treated skin sites showed mild to moderate erythema and mild to strong oedema. Between 24 hours and 14 days, the treated skin areas were cracked, dry-brittle, and scaly. Additionally scaling was observed. All signs of irritation were reversible.
Results for the 4 hour exposure period (3 animals): From 30 minutes to 21 days after application, the skin was temporarily sclerotic, vaulted, encrusted, scabby, white and brown-white discoloured. Additionally, skin induration was noted in two animals 21 days post exposure. In the remaining animal full thickness destruction of the epidermis occurred after 21 days.
Based on the results of this study, the test item was corrosive to rabbit skin.
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