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EC number: 244-859-1 | CAS number: 22235-81-0
- 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:
- 24 August to 29 October 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
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
Test material
- Reference substance name:
- Endo-(±)-8-aza-8-isopropylbicyclo[3.2.1]oct-3-yl (hydroxymethyl)phenylacetate
- EC Number:
- 244-859-1
- EC Name:
- Endo-(±)-8-aza-8-isopropylbicyclo[3.2.1]oct-3-yl (hydroxymethyl)phenylacetate
- Cas Number:
- 22235-81-0
- Molecular formula:
- C19H27NO3
- IUPAC Name:
- Endo-(±)-8-aza-8-isopropylbicyclo[3.2.1]oct-3-yl (hydroxymethyl)phenylacetate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
The Wistar rats were derived from a controlled full barrier-maintained breeding system (spf). Source: Harlan Winkelman GmbH, D-33178 Borchen
Step 1: 3 male animals with body weight range of 154-162 grams
Step 2: 3 female animals with body weight range of 145-149 grams
Step 3: 3 male animals with body weight range of 160-161 grams
ANIMAL HUSBANDRY
The animals were barrier maintained (semi-barrier) in air-conditioned rooms with the following conditions:
- Temperature: 22 +/- 3 degC
- Relative humidity: 55 +/- 10%
- Artificial light, lighting regime 12: 12hrs, light 6.00-18.00
- Air change: 10x per hour
Feeding ad libitum, Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free (TPF)
The animals were kept in Macrolon cages on Altromin saw fiber bedding with free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically).
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- The test item was administered in a single dose by gavage using an intubation cannula. Volume of application was applied according to the body-weight at a volume of 10ml/kg body weight.
- Doses:
- 200 and 2000 mg/kg
- No. of animals per sex per dose:
- Step 1: 3 male animals, dosed with 200 mg/kg bw
Step 2: 3 female animals, dosed with 200 mg/kg bw
Step 3: 3 male animals, dosed with 2000 mg/kg bw - Details on study design:
- The animals were weighed prior to first application and once a week thereafter.
A careful clinical examination was made twice a day on the day of dosing and once a day thereafter. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somamotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhea, lethargy, sleep and coma.
Rats were weighed on Day 0 (day before dosing), Day 7 and 14.
Results and discussion
Effect levels
- Key result
- Dose descriptor:
- LD50
- Effect level:
- >= 500 - <= 1 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Compound-related mortality of 2 out of 3 animals were observed at step 3 (2000 mg/kg bw).
- Clinical signs:
- observations of tremors
- other:
Any other information on results incl. tables
The acute toxic class method was performed with SCH 1000 / II-III Tropaester NV. It is the principle of the acute toxic class method that, based on a stepwise procedure with the use of a minimum number of animals per step, sufficient information is obtained on the acute toxicity of the test item to enable its classification.
In the first step the test item SCH 1000/ II-III Tropaester NV was given in a dose of 200 mg/kg body weight to a group of 3 male rats (HsdBrl:WH Wistar) in a single exposure via oral gavage. In a second step the test item was given to a group of 3 female rats (HsdBrl:WH Wistar) in a single exposure via oral gavage.
The dosage of 200 mg/kg bw caused no compound-related mortality neitller in the three male nor in the three female animals within 14 days p. appl.. Throughout the 14-days observation period no weight loss was recorded (table 1).
A careful clinical examination was made once a day. At the end of the observation period the animals were sacrificed and necropsy was carried out to re cord gross pathological changes. No clinical signs of toxicity were observed throughout the observation period. Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection no special gross pathological changes were found in animals of step 1 and step 2.
According to the acute toxic class method regime, in a third step the test item SCH 1000 / II-III Tropaester NV was given to a further group of three male animals in a dose of 2000 mg/kg bw.
The dosage of 2000 mg/kg bw caused compound-related mortality in two of three male animals within 24 hours p. appl. with showing clinieal signs as reduced spontaneous activity, apathy, tremor and prone position. No special gross pathological changes were found in this animals.
Since compound-related mortality of two of three animals was observed at step 3 (2000 mg/kg bw) no further testing was required. A careful clinical examination was made once a day with the surviving animal. No clinical signs of toxieity were observed throughout the observation period. At the end of the observation period the animal was sacrificed and necropsy was carried out to record gross pathological changes.
Beside acute injection of blood vessels in the abdominal region at the euthanised animal, which is due to the euthanasia injection, no special gross pathological changes were found.
According to the results obtained the LD50 was determined to be between 500 and 1000 mg/kg bw.
Table 1: Weight gain (in g) Step 1 and Step 2 (200mg/kg)
Animal No., sex | Day 0 | Day 7 | Day 14 |
1 male | 160 | 196 | 225 |
2 male | 162 | 197 | 241 |
3 male | 154 | 190 | 218 |
1 female | 145 | 168 | 185 |
2 female | 146 | 168 | 178 |
3 female | 149 | 178 | 196 |
Table 2: Weight Gain (in g) Step 3 (2000 mg/kg)
Animal No., Sex | Day 0 | Day 7 | Day 14 |
1 male | 161 | death after 24 hours | |
2 male | 160 | death after 30 mins | |
3 male | 160 | 185 | 238 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Considering the reported data of this toxicity test it can be stated that the test item SCH 1000/ II-III Tropaester NY has acute toxic characteristics.
The LD50 was determined to be between 500 and 1000 mg/kg BW.
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