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EC number: 638-747-5 | CAS number: 1228186-17-1
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from 1989-05-23 to 1989-06-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- For details on endpoint specific justification please see read-across report in section 13 or find a link in cross-reference “assessment report”.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- assessment report
- Irritation parameter:
- erythema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h, 48h, 72h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- scare formation after 14 days in 2/3 animals
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- scare formation after 14 days
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- scare formation after 14 days
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- edema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h, 48h, 72h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days in 2/3 animals
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- erythema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- other: no significant irritation noted
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- other: no significant irritation noted
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation noted
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- other: no significant irritation noted
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- edema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation noted
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation noted
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation noted
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation noted
- Remarks on result:
- other: 3 minute exposure
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item was corrosive after a 4 hour exposure period.
- Executive summary:
The study used as source investigated skin irritation/corrosion. The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (structural analogue) is outlined in the read-across report in section 13 or find a link in cross reference “assessment report”.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1989
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:
- Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides
- EC Number:
- 263-090-2
- EC Name:
- Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides
- Cas Number:
- 61789-80-8
- Molecular formula:
- R2Me2N(+)Cl(-) whereas R = mainly C16, 18-alkyl molecular weight range is based on R=14 (lower limit value) and R=18 (higher limit value)
- IUPAC Name:
- N,N-Dimethyl-N,N-di-n-alkyl(C16-18)-ammoniumchloride
- Details on test material:
- - Name of test material (as cited in study report): Genamin DSAC (Dioctadecyldimethylammonium chloride)
- Physical state: paste
- Composition of test material, percentage of components: approximately 97% active, 3% water
- Isomers composition: n.a.
- Purity test date: no data
- Lot/batch No.: E01-23696GD
- Expiration date of the lot/batch: 1988
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: stable
- Storage condition of test material: darkness, room temperature
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, Germany
- Age at study initiation: ca. 3 - 5 month
- Weight at study initiation: 2.2 - 3.0 kg
- Housing: individually, stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 hour interval
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours, 3 minutes
- Observation period:
- 14 days
- Number of animals:
- 3 (4 h), 3 (3 min)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h, 48h, 72h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- scare formation after 14 days in 2/3 animals
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- scare formation after 14 days
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- scare formation after 14 days
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- edema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h, 48h, 72h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days in 2/3 animals
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: 4 hour exposure
- Irritation parameter:
- erythema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- other: no significant irritation noted
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- other: no significant irritation noted
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation noted
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- other: no significant irritation noted
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- edema score
- Remarks:
- overall
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation noted
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation noted
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation noted
- Remarks on result:
- other: 3 minute exposure
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24h, 48h, 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation noted
- Remarks on result:
- other: 3 minute exposure
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Technical grade Praepagen WK (77% dioctadecyldimethylammonium chloride, 11.3% isopropanol, 11.7% water) was corrosive after a 4 hour exposure period.
- Executive summary:
In a GLP conform study, Praepagen WK (77% active in isopropanol/water) was tested for skin irritation / corrosion according to OECD test guideline 404. For this 0.5 mL of moistened Praepagen WK was applied semi-occlusively for 3 minutes or 4 hours to the shaved skin of three or one New Zealand White rabbits, respectively. The skin then was examined 30 - 60 minutes and 24, 48 and 72 hours after removal of the dressing. Since effects were still present after 72 hours, additional readings were performed after 7 and 14 days. Results for the 3 minute exposure period (3 animals): One hour and 24 hours following removal of the patches slight erythema were noted in two animals. No signs of irritation were observed after 48 hours and later. Results for the 4 hour exposure period (3 animals): One hour after removal of the patches the skin of the animals exhibited slight erythema and moderate oedema. At the 24 to 72 hour readings moderate erythema and slight to moderate oedema were observed. Additionally the skin was leathery. Seven days p.a. moderate to severe erythema in all animals and slight oedema in one animal appeared. Swelling of the other animals couls not be assessed because of induartion. This was still partially the case after 14 days. In two rabbits well-defined to severe erythema and slight oedema were observed at this time point. The skin was also indurated, raised, scabbed, chapped, parchement-like and with fine or coarse scales. A scar had developed in two animals 14 days after the apllication. Based on the results of this study, Praepagen WK (77% active in isopropanol/water) should be classified as corrosive to skin.
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