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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From Dec. 12, 2003 to Feb. 26, 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Albino
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Rationale for alternative/additional species to rat (if applicable): N/A
- Source: Ace Animals, Boyertown, PA
- Females nulliparous and non-pregnant: yes
- Rationale for use of males (if applicable): N/A
- Age at study initiation: 8-12 weeks at experimental start
- Weight at study initiation: 187 - 244 grams. The weight variation of each animal used did not exceed .±20% of the mean initial weight of all previously dosed animals.
- Fasting period before study: 16-20 hours
- Housing: The animals were housed in suspended wire mesh cages; 1/cage. Bedding was placed beneath the cages and changed at least three times/week. The animal room, reserved exclusively for rats on acute tests, was temperature controlled, and equipped with a 12-hour light/dark cycle. Temperature and humidity were continuously recorded using automatic recording devices.
- Historical data:
- Diet (e.g. ad libitum): fresh PMI Rat Chow (Diet #5012)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five (5) days prior to experimental start.
- Microbiological status when known:
- Method of randomisation in assigning animals to test and control groups: From the available pool of animals, healthy rats of the sex and weight range specified herein will be selected for dosing without conscious bias.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
IN-LIFE DATES: From: Dec 17, 2003 To: Feb 12, 2004
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The dose was based on the dry weight of the test article. Initially, a single female Wistar rat was dosed orally by syringe and dosing needle at a dose level of 2000 mg/kg. Due to the death of the first animal, additional animals were dosed, one at a time, by a single ordered dose progression.
- Doses:
- 175, 550, 2000 mg/kg bw/day
- No. of animals per sex per dose:
- 6 animals 2000 mg/kg bw/day
3 animals 550 mg/kg bw/day
1 animal 175 mg/kg bw/day - Control animals:
- no
- Remarks:
- Not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 1/2, 1,2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly, at death and at termination in the survivors.
- Necropsy of survivors performed: yes. All animals were humanely sacrificed using CO2 following study termination and examined for gross pathology. Abnormal tissues were preserved in 10% buffered formalin for possible future microscopic examination.
- Clinical signs including body weight : yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: - Statistics:
- The LD50 and 95% Confidence Limits were calculated using AOT425 Stat Pgm provided by the EPA.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 793.2 - 20 000
- Mortality:
- 4/6 animals at 2000 mg/kg bw/day
0/3 animals at 550 mg/kg bw/day
0/1 animal at 175 mg/kg bw/day - Clinical signs:
- other:
- Body weight:
- greater than 10% body weight loss
- Remarks:
- Body weight changes of survivors were generally normal. One survivor dosed at 550 mg/kg (#9) lost weight during the second week of the observation period.
- Gross pathology:
- Necropsy results of the dead animals revealed abnormalities of the lungs, thymus, liver, adrenals and gastrointestinal tract, as well as chromorhinorrhea, chromodacryorrhea, red staining of the nose/mouth area, yellow staining of the anogenital area and soiling of the anogenital area.
Necropsy results of the survivors were normal.
Any other information on results incl. tables
Mortality responses to the oral dosing:
Animal # (F) | Dose mg/kg | Response (O=alive, X=dead) |
1 | 2000 | X |
2 | 175 | 0 |
3 | 550 | 0 |
4 | 2000 | 0 |
5 | 2000 | 0 |
6 | 2000 | X |
7 | 550 | 0 |
8 | 2000 | X |
9 | 550 | 0 |
10 | 2000 | X |
Table 1: Dose Volume, Dose Level and Body Weights in grams
An.# | Sex | Dose | Dose Volume | Body Weight (g) | Body Weight (g) | Body Weight (g) |
1 | F | 2000 | 0.81 | 203 | - | |
2 | F | 175 | 0.072 | 206 | 244 | 246 |
3 | F | 550 | 0.26 | 240 | 259 | 282 |
4 | F | 2000 | 0.89 | 222 | 264 | 270 |
5 | F | 2000 | 0.98 | 244 | 285 | 290 |
6 | F | 2000 | 0.79 | 197 | - | - |
7 | F | 550 | 0.21 | 187 | 228 | 241 |
8 | F | 2000 | 0.82 | 206 | - | - |
9 | F | 550 | 0.22 | 207 | 275 | 272 |
10 | F | 2000 | 0.8 | 200 | - | - |
Table 2: Systemic Observations
DOSE - mg/kg | 2000 | 175 | 550 | 2000 | 2000 | 2000 | 550 | 2000 | 550 | 2000 |
Animal # / Sex | 1/F | 2/F | 3/F | 4/F | 5/F | 6/F | 7/F | 8/F | 9/F | 10/F |
Time Periods |
| |||||||||
1/2 Hour | D | |||||||||
1 Hour | D,T | D,T | D,T | D,T | ||||||
2 Hour | D,T | D | D,T | D,T | ||||||
4 Hour | D,T | D,T | D,T | D,T | D,T | D,T | ||||
Day 1 | X,D,R,B | T | T | X,T | D,T,X,3 |
| R | |||
Day 2 | B,X,T,W.J,1,2 |
| T | R,X | T,X | X | D,T,X,R,4,5 |
| R,X,B,2,4.5 | |
Day 3 | Z (162g) | X | T,X,8,Q,S.F | X | Z (163g) |
| Z (177g) | |||
Day 4 | Z (171g) | |||||||||
Day 5 | ||||||||||
Day 6 | ||||||||||
Day 7 | ||||||||||
Day 8 | ||||||||||
Day 9 | ||||||||||
Day 10 | ||||||||||
Day 11 | ||||||||||
Day 12 | ||||||||||
Day 13 | ||||||||||
Day 14 |
No entry indicates animal appeared normal at that observation period. Systemic observation code is on page preceding systemic observation tables.
TOXICITY CODE
B = Lethargy
D = Diarrhea
F = Piloerection
J = Chromodacryorrhea
Q = Sagging eyelids
R = Anogenital area wet
S = Chromorhinorrhea
T = Anogenitaf area soiled
W = Appears emaciated
X = Few feces
Z = Dead
1 = Lacrimation of the eyes
2 = Hunched posture
3 = Nose/mouth area wet
4 = Nose/mouth area stained red
5 = Front paws stained red
Table 3: Necropsy Observations
DOSE - mg/kg | 2000 | 175 | 550 | 2000 | 2000 | 2000 | 550 | 2000 | 550 | 2000 |
Animal # / Sex | 1/F | 2/F | 3/F | 4/F | 5/F | 6/F | 7/F | 8/F | 9/F | 10/F |
Observations | D | S | S | S | S | D | S | D | S | D |
Normal |
| X | X | X | X |
| X |
| X |
|
Chromodacryorrhea | 3 |
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| 1 |
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Chromorhinorrhea |
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| 1 |
Nose/mouth area: stained red |
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| 2 |
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Anogenital area: stained yellow | 1 |
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Anogenital area: soiled | 1 |
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| 2 |
| 2 |
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Lungs: red areas | 3 |
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| 1 |
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Thymus: dark areas | 1 |
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Liver: dark areas |
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| 2 |
Adrenals: darker than normal | 1 |
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| 1 |
Adrenals: larger than normal | 1 |
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| 1 |
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| 1 |
Stomach: red areas | 1 |
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| 1 |
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| 1 |
Stomach: distended with gas | 1 |
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Stomach: distended with mucus | 1 |
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| 2 |
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Intestines: red areas | 1 |
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| 3 |
| 2 |
| 2 |
Intestines: distended with mucus | 1 |
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| 1 |
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Intestines: yellow areas | 1 |
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| 2 |
| 2 |
Cecum: darker than normal |
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| 2 |
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Stomach: contains white substance |
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| 1 |
CODES:
D= death
S =sacrifice
X = observed
1=slight or scattered
2= moderate or few
3= pronounced or many
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The estimated acute oral LD50 and 95% confidence limits are: 2000 (793.2 - >20,000) mg/kg.
- Executive summary:
According to the results obtained from an acute oral toxicity study in rats, the estimated acute oral LD50 and 95% confidence limits of N-(4-(methoxybenzyl))-N,N-dimethylanilinium hexafluoroantimonate are: 2000 (793.2 - >20,000) mg/kg.
The substance meets the GHS criteria for classification as Category 4 for acute oral toxicity.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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