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EC number: 836-285-0 | CAS number: 125349-37-3
- 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:
- 02 - 16 Oct 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- GLP compliance unknown, minor deviations from guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- adopted 17 Dec 2001
- Deviations:
- no
- Remarks:
- - Animals should be 8-12 weeks old, but were 7 weeks old - No information on sighting study - In case of at least 2 mortalities amongst test animals, the dose 300 mg/kg bw should have been tested
- GLP compliance:
- no
- Remarks:
- in-house safety study
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- (3R-)1,1,3-trimethylindan-4-amine
- EC Number:
- 836-285-0
- Cas Number:
- 125349-37-3
- Molecular formula:
- C12H17N
- IUPAC Name:
- (3R-)1,1,3-trimethylindan-4-amine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD (SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan
- Age at study initiation: 7 weeks
- Weight at study initiation: 159 - 174 g
- Fasting period before study: Animals were fasted 20 h prior to administration and 4 h after.
- Housing: 2 - 3 animals per cage in aluminium cages equipped with 5 shelves and 5 ladders
- Diet: solid feed for mice/rats (CRF-1, Oriental Yeast Co., Ltd.); ad libitum (besides fasting period)
- Water: filter-treated Osaka municipal tap water automatic water drinking device; ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 26
- Humidity (%): 40 - 70
- Air changes (per hr): ≥ 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- stock solution administered
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.06 mL/kg (2000 mg/kg bw); forced oral administration
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 10 and 30 min and 1, 2 and 4 h after administration and once daily thereafter, for 14 days. Individual body weights were determined immediately before administration, 7 and 14 days after administration, and in the event of being discovered dead.
- Necropsy: performed upon completion of the observation period, and in the event of being discovered dead
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000
- Based on:
- test mat.
- Remarks on result:
- other: 2/5 animals died at 2000 mg/kg bw. No higher concentrations were tested and no statistics were applied to determine the precise LD50.
- Mortality:
- In the 2000 mg/kg bw group, 2 animals were found dead 1 day after administration (cumulative number of deaths: 2/5).
- Clinical signs:
- irregular respiration
- other:
- Gross pathology:
- The surviving animals in the 2000 mg/kg bw group exhibited no effects attributable to test substance administration. In the animals that were found dead, scattered brown foci on the gastric mucosa were observed in 1 animal, and scattered red foci on the gastric mucosa were observed in 1 animal.
Applicant's summary and conclusion
- Interpretation of results:
- other: Acute Oral 4 (H302) according to Regulation (EC) No 1272/2008
- Conclusions:
- In this acute oral toxicity study in 5 female rats receiving one dose of 200 mg/kg bw, the test substance (3R-)2,3-dihydro-1,1,3-trimethyl-1H-inden-4amine induced mortality in 2/5 animals, and the LD50 was > 2000 mg/kg bw. According to the OECD 420 testing of an additional dose (300 mg/kg bw) is required in case of 2 or more dead animals at a starting dose of 2000 mg/kg bw associated with a classification for Acute oral 4 (H302) according to Regulation (EC) No. 1272/2008. This step is missing in the available Japanese acute oral toxicity study with (3R-)2,3-dihydro-1,1,3-trimethyl-1H-inden-4amine. In addition, the substance 1,1,3-trimethylindan-4-amine (CAS 94568-76-0), which consists to 50% of (3R-)2,3-dihydro-1,1,3-trimethyl-1H-inden-4amine (CAS 125349-37-3) is classified for Acute Oral 4 (H302). Therefore, a worst-case approach was applied for (3R-)2,3-dihydro-1,1,3-trimethyl-1H-inden-4amine, which resulted in the decision that (3R-)2,3-dihydro-1,1,3-trimethyl-1H-inden-4amine is also classified for Acute Oral 4 (H302).
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