Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 15 - 18 Oct 2013
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The test substance was spread on lint, which was applied and sealed onto the dorsal skin of one male rabbit under occlusive conditions for 4 h. Following application, the test substance was removed from the application site by wiping with an absorbent cotton soaked with acetone. The site was observed, in accordance with the Draize test, 1, 24, 48 and 72 h after removal of the test substance, the primary irritation index was calculated, and evaluation was performed.
- GLP compliance:
- 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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd.
- Sex: male
- Age at study initiation: 16 weeks
- Weight at study initiation: 2975 g
- Housing: The animal was housed individually in a suspended stainless-steel cage comprising stainless steel wire mesh front and floor, and aluminium walls (W590 × D636 × H430 mm, Clea Japan, Inc.). Once every 2 weeks, the cage was changed for a washed, sterile cage.
- Diet: Solid rabbit feed (LRC4, Oriental Yeast) was available ad libitum at ca. 120 g/day.
- Water: Tap water was provided freely available via an automatic water dispensing device (Lab Engineering Co., Ltd.).
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): ≥ 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL unchanged test substance - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 1 male
- Details on study design:
- TEST SITE
- Area of exposure: dorsal skin
- Type of wrap if used: lint spread with test substance (2.5 × 2.5 cm^2), occlusive sealing
REMOVAL OF TEST SUBSTANCE
- Washing: The application site was wiped using absorbent cotton soaked with acetone to remove the test substance.
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize scoring system
OBSERVATION TIME POINTS
1, 24, 48, 72 h after removal of test substance
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- In observation after application, erythema (score: 2) and edema (score: 1) were observed at the site of application at observation point 1 h after application. These local reactions decreased at observation points 24 and 48 h (score 1 for erythema and edema, respectively) and completely disappeared 72 h after removal of the test substance. The primary irritation index (PDII) was 1.8, based on the sum of severities of local reactions (scores) for up to 72 h, divided by 4.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- Under the present test conditions, the test substance (3R-)2,3-dihydro-1,1,3-trimethyl-1H-inden-4amine was assessed to be mildly irritant to the skin according to Draize criteria (PDII of 1.8). However, there is no need for classification according to Regulation (EC) No. 1272/2008.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.