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EC number: 610-954-5 | CAS number: 53075-09-5
- 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
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- Nanomaterial pour density
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- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
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- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Tricyclo[3.3.1.13,7]decan-1-aminium, N,N,N-trimethyl-, hydroxide (1:1)
- EC Number:
- 610-954-5
- Cas Number:
- 53075-09-5
- Molecular formula:
- C13 H25 N O
- IUPAC Name:
- Tricyclo[3.3.1.13,7]decan-1-aminium, N,N,N-trimethyl-, hydroxide (1:1)
- Details on test material:
- - Name of test substance: Adamantyltrimethylammoniumhydroxid 20%
- Batch identification: ADTAOH 20%
- CAS No.: 53075-09-5
- Purity: 20.1 g/100g
- Homogeneity: The test substance was homogeneous by visual inspection.
- Storage conditions: Room temperature/ under N2
- Physical state/ color: Liquid/ colorless, clear
- Density [g/mL]: 1.040 (determined by Bioassay)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: Young adult animals (female animals approx. 10 – 11 weeks)
- Sex: As suggested by the OECD guideline nulliparous and non-pregnant female animals were used for the test, because there is no indication that male animals are likely to be more sensitive to the acute effects of the test substance.
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Fasting period before study:
- Housing: Single housing in Makrolon cages, type III
- Diet: VRF1(P); SDS Special Diets Services, Altrip, Germany
- Water: Tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 20-80
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- FORM OF ADMINISTRATION:
2000 mg/kg bw group: Undiluted (no vehicle)
300 mg/kg bw: Solution in doubly distilled water
VEHICLE
- Concentration in vehicle: 300 mg/kg bw group: 15 g/100 ml
- Justification for choice of vehicle: Aqueous formulation corresponds to the physiological medium.
MAXIMUM DOSE VOLUME APPLIED:
2 ml/kg bw
DOSAGE PREPARATION:
The test-substance preparations of the 300 mg/kg bw test groups were produced shortly before the administrations by stirring with a magnetic stirrer. - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 2000 mg/kg bw group: 3 females
300 mg/kg bw group: 2 x 3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A check for any dead or moribund animal was made twice each workday and once on weekends and on public holidays. Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals. Recording of individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. Additionally, at day of death in animal which was sacrificed moribund on study day 8.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One animal of the 2000 mg/kg test group was found dead at hour 1 and one animal was sacrificed in a moribund state on study day 8.
No mortality occurred in the 300 mg/kg administration groups. - Clinical signs:
- other: Clinical observation in the 2000 mg/kg body weight test group revealed impaired general state, dyspnea, salivation, piloerection, exsiccosis, gasping, twitching, clonic convulsions, reduced and non feces. Findings were observed from hour 0 through to stud
- Gross pathology:
- At necropsy the animals of the 2000 mg/kg test group which died or were sacrificed in a moribund state showed red discoloration of the lung, red to brown discolored content of the stomach, rigidity of the stomach wall covered with mucus, areal bleeding of the glandular stomach. Furthermore light red spotted discoloration of the liver and red discoloration of the small intestine was recorded. No macroscopic pathologic abnormalities were noted in the surviving animals examined on the last day of observation (2000 mg/kg bw: 1 female; 300 mg/kg bw: 6 females).
Any other information on results incl. tables
Mortality data:
Dose (mg/kg bw) |
2000 |
300 |
300 |
Sex |
female |
female |
female |
Administration |
1 |
1 |
2 |
No. of animals |
3 |
3 |
3 |
Mortality (animals) |
2 |
No mortality |
No mortality |
Individual body weight changes:
Dose (mg/kg bw) |
2000 |
300 |
300 |
|||||||||
Administration |
1 |
1 |
2 |
|||||||||
Animal No. |
1 |
2 |
3 |
mean |
1 |
2 |
3 |
mean |
1 |
2 |
3 |
mean |
Body weight at study day (g) |
|
|||||||||||
0 |
173 |
188 |
173 |
178 |
196 |
201 |
186 |
194 |
190 |
180 |
163 |
178 |
7 |
180 |
148 |
+ |
164 |
214 |
218 |
201 |
211 |
199 |
186 |
168 |
184 |
8 |
+ |
147* |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
14 |
185 |
+ |
+ |
185 |
221 |
218 |
202 |
214 |
205 |
186 |
174 |
188 |
+: no further data; *: weight at death
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study the median lethal dose of Adamantyltrimethylammoniumhydroxid 20% after oral administration was found to be greater than 300 mg/kg and less than 2000 mg/kg body weight in rats.
- Executive summary:
The study was performed according to OECD guideline 423 in compliance with GLP to assess the acute toxicity following oral administration of Adamantyltrimethylammoniumhydroxid 20% in Wistar rats.
Single doses of 2000 and 300 mg/kg body weight of the test material or test material preparations in doubly distilled water were given to three test groups of three fasted female animals each, (2000 mg/kg bw in 3 females, 300 mg/kg bw in 6 females) by gavage in a sequential manner.
One animal of the 2000 mg/kg test group was found dead at hour 1 and one animal was sacrificed in a moribund state on study day 8. No mortality occurred in the 300 mg/kg administration groups. Clinical observation in the 2000 mg/kg body weight test group revealed impaired general state, dyspnea, gasping, salivation, piloerection, exsiccosis, twitching, clonic convulsions, reduced and non feces. Findings were observed from hour 0 through to study day 8 after administration. No clinical signs and findings were observed in the 300 mg/kg test groups. The mean body weight of the 2000 mg/kg body weight administration group decreased in the first exposure week, but increased during the second exposure week. This effect was observed because the moribund sacrificed animal showed a marked loss of body weight. The mean body weights of the test 300 mg/kg groups increased normally throughout the study period. At necropsy the animals of the 2000 mg/kg test group which died or were sacrificed in a moribund state showed red discoloration of the lung, red to brown discolored content of the stomach, rigidity of the stomach wall covered with mucus, areal bleeding of the glandular stomach. Light red spotted discoloration of the liver, red discoloration of the small intestine. No macroscopic pathologic abnormalities were noted in the surviving animals examined on the last day of observation (2000 mg/kg bw: 1 female; 300 mg/kg bw: 6 females).
Under the conditions of this study the LD50 of Adamantyltrimethylammoniumhydroxid 20% after oral administration was found to be greater than 300 mg/kg and less than 2000 mg/kg body weight in rats.
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