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EC number: 457-280-6 | 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: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Dec. 15, 2003 to Jan. 28, 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- July 17, 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 457-280-6
- EC Name:
- -
- Cas Number:
- 126803-19-8
- Molecular formula:
- C16H20F6NOSb
- IUPAC Name:
- λ⁵-antimony(5+) N-[(4-methoxyphenyl)methyl]-N,N-dimethylanilinium hexafluoride
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Corporate Toxicology
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature and humidity
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): The test article was individually weighed and moistened with 0.3 ml of distilled water to form a paste.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: The animals were housed 1/cage in suspended wire cages. Bedding was placed beneath the cages and changed at least three times/week. The animal room, reserved exclusively for rabbits on acute tests, was temperature controlled, had a 12 hour light/dark cycle, and was kept clean and vermin free.
- Diet (e.g. ad libitum): Fresh PMI Rabbit Chow (Diet #5321) was provided daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):12 hour light/dark cycle
IN-LIFE DATES: From: Dec. 16, 2003 To: Ja. 2, 2004
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- The day prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. The prepared site, was approximately 10 x 10 cm and remained intact.
- Vehicle:
- water
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): The test article was individually weighed and moistened with 0.3 ml of distilled water to form a paste. - Duration of treatment / exposure:
- 3 min, 1 h, 4 h (Animal 1)
4 h (Animal 2 & 3))
The test article (0.5 g) was applied dermally to three intact sites for an exposure period of three minutes on site #1, one hour on site #2 and four hours on site #3. - Observation period:
- Dermal reactions were scored at 60 minutes after each patch removal on all three sites. Site #3 was scored again at 24, 48 and 72 hours.
- Number of animals:
- 3 (Animal 1 and Animal 3: males, Animal 2: female)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage:
- Type of wrap if used: plastic (semi-occlusive)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): distilled water
- Time after start of exposure: Animal 1 (male) - 3 min (site #1), 1h (site #2), 4h (site #3). Animal 2 (female) and Animal 3 (male) - 4h (site #3)
OBSERVATION TIME POINTS
(indicate if minutes, hours or days)
The test sites of all animals were scored for dermal irritation at 60 minutes after removal of wrappings. Site #3 was scored at 24, 48 and 72 hours.
SCORING SYSTEM:
- Method of calculation: Erythema and edema were scored according to the numerical Draize technique. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Male, Site #1 - 3min exposure
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Male, Site #2 - 1h exposure
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Male, Site #3 - 4h exposure
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Female, Site #3 - 4h exposure
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Male, Site #3 - 4h exposure
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Male, Site #3 - 4h exposure
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Female, Site #3 - 4h exposure
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Male, Site #3 - 4h exposure
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Male, Site #1 - 3min exposure
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Male, Site #2 - 1h exposure
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Male, Site #3 - 1h exposure
- Time point:
- other: 1 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Male, Site #3 - 4h exposure
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Female, Site #3 - 4h exposure
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Male, Site #3 - 4h exposure
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Dermal Observations (Table 1)
Initial animal- There was no erythema or edema noted-at any of the observation time periods.
Additional animals - There was no erythema or edema noted at any observation time period. - Other effects:
- Systemic Observations (Table 1)
There were no abnormal physical signs noted during the observation period.
All body weight changes were normal.
Any other information on results incl. tables
Table 1: Dermal Observations, Body Weight and Systemic Observations | |||||
Animal No | Animal 1 | Animal 2 | Animal 3 | ||
Sex | M | F | M | ||
Pretest Body Weight - Kg | 2.2 | 2.6 | 2.7 | ||
Terminal Body Weight - Kg | 2.5 | 2.6 | 2.7 | ||
Exposure time | Time after patch removal | Erythema & Escar Formation | Mean scores | ||
Site #1 - 3 min | 1h | 0 | N/A | N/A | |
Site #2 - 1h | 1h | 0 | N/A | N/A | |
Site #3 - 4h | 1h | 0 | 0 | 0 | 0 |
Site #3 - 4h | 24h | 0 | 0 | 0 | 0 |
Site #3 - 4h | 48h | 0 | 0 | 0 | 0 |
Site #3 - 4h | 72h | 0 | 0 | 0 | 0 |
Exposure time | Time after patch removal | Edema | Mean scores | ||
Site #1 - 3 min | 1h | 0 | N/A | N/A | |
Site #2 - 1h | 1h | 0 | N/A | N/A | |
Site #3 - 4h | 1h | 0 | 0 | 0 | 0 |
Site #3 - 4h | 24h | 0 | 0 | 0 | 0 |
Site #3 - 4h | 48h | 0 | 0 | 0 | 0 |
Site #3 - 4h | 72h | 0 | 0 | 0 | 0 |
Sum of Mean Scores = | 0 | ||||
Modified Primary Irritation Index(PII)= Sum of Mean Scores/2= | 0 | ||||
Systemic observations | |||||
1h | A | A | A | ||
24h | A | A | A | ||
48h | A | A | A | ||
72h | A | A | A | ||
A=Normal | |||||
N/A = not applicable |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- N-(4-(methoxybenzyl))-N,N-dimethylanilinium hexafluoroantimonate is not a dermal irritant.
- Executive summary:
There was no erythema or edema noted at any of the observation time periods in any animal.
There were no abnormal physical signs noted during the observation period. All body weight changes were normal.The Modified Primary Irritation Index for the test substance is 0 and thus it is not a dermal irritant.
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