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EC number: 200-510-5 | CAS number: 61-54-1
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study according to international accepted guidelines and GLP compliant.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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:
- no
Test material
- Reference substance name:
- 2-(indol-3-yl)ethylamine
- EC Number:
- 200-510-5
- EC Name:
- 2-(indol-3-yl)ethylamine
- Cas Number:
- 61-54-1
- Molecular formula:
- C10H12N2
- IUPAC Name:
- 2-(1H-indol-3-yl)ethan-1-amine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test item: Tryptamine
CAS No.: 61-54-1
Batch No.: S37020N
Physical state: solid, amorphous powder
Colour: yellowish-brown
Active ingredient content: 99 %
Storage: 8-15 °C, protected from light and moisture
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain: Crl:(WI)Br rats
Source: TOXI COOP ZRT.
Hygienic level at arrival: SPF
Sex: Female, nulliparous and non pregnant animals
Age of animals: Young adult rat, 8 weeks old in first, second and third step
Body weight range: at starting (first step): 165 - 169 g
Body weight range: at starting (second step): 162 - 168 g
Body weight range: at starting (third step): 155 - 168 g
Housing: Group caging (3 animals/cage)
Light: Artificial light, from 6 a.m. to 6 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: 10-15 air exchanges/hour by central air-condition system.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Helianthi annui oleum raffinatum
- Details on oral exposure:
- A single oral administration - followed by a fourteen-day observation period - was performed by gavage.
Starting dose was selected on the basis of the available information about the test item. The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. Since two female animals died on the treatment day and one animal died on Day 3, the test was continued at 300 mg/kg bw dose level on further three female rats.
No animal died in the second step at 300 mg/kg bw dose level, three further female rats were treated with the same (300 mg/kg bw) dose.
All doses were formulated in the vehicle. Concentration of formulations was adjusted to maintain a treatment volume of 10 mL/kg bw. The test item was applied in a concentration of 200 and 30 mg/mL. Formulations were prepared just before the administration and stirred continuously during the treatment.
The day before treatment the animals were fasted. The food but not water was withheld overnight. The food was given back 3 hours after the treatment. - Doses:
- 2000, 300 mg/kg bw
- No. of animals per sex per dose:
- 3 female/dose
- Control animals:
- no
- Details on study design:
- The observation period was 14 days. Animals were observed individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h, 5 h and 6 h after the treatment and twice each day for 14 days thereafter.
The body weights were recorded on day 0 (just before the treatment), on day 7 and on day 15 with a precision of 1 g.
At the end of the observation period the survivor rats were sacrificed and necropsy were performed.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 300 - 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Two rats dosed at 2000 mg/kg bw TRYPTAMINE (CAS 61-54-1) died on the treatment day 1 hour after the treatment and one animal died on Day 3. All deaths seemed to be consequences of systemic toxic effect of the test item.
No death occurred at 300 mg/kg single oral dose of the test item. All female rats in step 2 and step 3 survived until the end of the 14-day observation period. - Clinical signs:
- other: In group 1 treated with 2000 mg/kg dose: Decreased activity (score -1; -3; -4), tremor (score +1; +2; +3), tonic convulsion (score +1), clonic convulsion (score +1; +2) abnormal gait (score +1; +4), lateral position (score +3; +4), decreased righting refl
- Gross pathology:
- All rats treated with 2000 mg/kg bw dose of the test item spontaneously died during the study. Internal necropsy finding as bloody content in the intestines was observed in two animals of group 1. This alteration could be related to the test item toxic effect. An internal necropsy finding as autolysis was observed in one animal. It is normal physiological process after death.
All animals treated with 300 mg/kg bw dose survived until the scheduled necropsy on Day 15. Internal necropsy finding as pale kidneys was observed in one animal of group 2 and in an other animal of group 3. This alteration could not be related to the test item toxic effect, but was regarded an individual variation. Most likely the observation is a congenital anomaly. Slight hydrometra was detected in one animal of group 2 and in an other animal of group 3, as well as moderate hydrometra was observed in one female of the group 2. The hydrometra is physiological finding and connected to the cycle of the animal.
Any other information on results incl. tables
Groups |
Treatment |
Lethality |
|
Test item |
Dose (mg/kgbw) |
Females |
|
1 |
“tryptamine” |
2000 |
3/3 |
2 |
“tryptamine” |
300 |
0/3 |
3 |
“tryptamine” |
300 |
0/3 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The method used, was not intended for the precise calculation of a precise LD50 value.
The test item was ranked into classes of Globally Harmonized Classification System (GHS) described in the OECD Guideline No. 423.
Hazard Category: Acute Tox. 4 - Executive summary:
Dose (mg/kg bw) Mortality (dead/treated) LD50 (mg/kg bw) GHS category 300 0/6 between 300 and 2000 4
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