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EC number: 612-154-1 | CAS number: 6147-66-6
- 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:
- May 2021 to June 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- bis(prop-2-en-1-yl)amine hydrochloride
- EC Number:
- 612-154-1
- Cas Number:
- 6147-66-6
- Molecular formula:
- C6H11N.HCl
- IUPAC Name:
- bis(prop-2-en-1-yl)amine hydrochloride
- Test material form:
- liquid
- Remarks:
- Salt dissolved in water
Constituent 1
- Specific details on test material used for the study:
- 66% purity
Aqueous solution
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: In-house bred animals
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 9 to 10 weeks
- Weight at study initiation: 163.98 g to 178.19 g
- Fasting period before study: overnight (16 to 18 hours)
- Housing: standard polysulphonate cage (Size: L 430 x B 280 x H 210 mm) with stainless steel mesh top grill having facilities for holding pelleted feed and drinking water bottle fitted with stainless steel sipper tube. Clean sterilized paddy husk was provided as bedding material.
- Diet: Altromin Maintenance Diet for rats and mice (manufactured by Altromin Spezialfutter GmbH & Co. KG) was provided ad libitum.
- Water: Water was provided ad libitum throughout the acclimatization and experimental period. Deep bore-well water passed through reverse osmosis unit.
- Acclimation period: Heathly young adults were used for Sighting Study I, Sighting Study II and Main study were acclimatized for five, seven and nine days respectively.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.6 to 22.8
- Humidity (%): 46 to 64
- Air changes (per hr): 12 to 15
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
Distilled water
Batch No: 515
Manufacture Date: 31/03/2021
Expiry Date: 30/03/2022
Manufactured by: Mysore Research Chemical Laboratories
Required quantity of test item as weighed as per the dose. The weighed test item was mixed well using a glass rod by adding a little volume of vehicle and then transferred to a measuring cylinder. Again, a small quantity of vehicle was added and transferred into the measuring cylinder. This was repeated until the complete transfer of the test item into the measuring cylinder. The final volume was made up to mark in measuring cylinder with vehicle to get the desired concentration as per dose requirement.
Sighting Study I (300 mg/kg body weight)
Concentration (mg/mL) - 30
Quantity of Test item - 150. 2 mg
Volume of vehicle - 5 mL
Sighting Study II (2000 mg/kg body weight)
Concentration (mg/mL) - 200
Quantity of Test item - 1000.0 mg
Volume of vehicle - 5 mL
Main Study (2000 mg/kg body weight)
Concentration (mg/mL) - 200
Quantity of Test item - 2000.1 mg
Volume of vehicle - 10 mL - Doses:
- 300 and 2000 mg/kg body weight
- No. of animals per sex per dose:
- One animal at 300 mg/kg bodyweight (sighting study I)
One animal at 2000 mg/kg body weight (sighting study II)
Four animals at 2000 mg/kg body weight (Main Study) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 20 to 30 min, 1 hour, 2 hours, 3 hours and 4 hours post-dosing on day 1 and one daily thereafter for clinical signs of toxicity and twice daily for mortality during 14 days observation period.
- Frequency of observations and weighing: Body weight was recorded on receipt, on day 1 before test item administration and on days 8 and 15 during the observation period.
- Necropsy of survivors performed: yes
- Clinical signs including body weight, changes in skin, fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern.
Results and discussion
- Preliminary study:
- The test item was administered through oral gavage as a single dose of 300 mg/kg body weight to one female rat in Sighting Study I. No clinical signs of toxicity or mortality was observed.
Sighting Study II was conducted using one female rat after approximately 24 hours of observation by administering a single dose of 2000 mg/kg body weight of the test item. No clinical signs of toxicity and morality was observed.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in any of the dosed animals
- Clinical signs:
- other: No clinical signs of toxicity was observed in any of the dosed animals.
- Gross pathology:
- No gross pathological changes were observed in any of the dosed animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LD50 value for the test item 2-propen-1-amine, N-2-propen-1-yl, hydrochloride is > 2000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rat as per OECD Guideline 420.
- Executive summary:
The Acute Oral toxicity of test item 2-propen-1-amine, N-2-propen1-yl, hydrochloride was determined according to OECD Guideline 420 under GLP compliance.
The fixed dose method was used. One female rat received by gavage a single dose of 300 mg/kg body weight in water. In the absence of observable toxicity at 300 mg/kg body weight, an animal was treated at 2000 mg/kg body weight. Considering that no mortality of clear clinical signs of toxicity were observed, four additional female rats were treated at 2000 mg/kg body weight.
Following exposure to the test substance, the animals were observed for 14 days. Clinical observations were made at 30 minutes, 1, 2 and 4 hours after dosing and then daily until the end of the observation period. Morbidity and mortality checkes were made twice daily. Individual body weights were recorded on day 0 (day of dosing) and on days 8 and 15. At the end of the observation period the animals were killed by carbon dioxide asphyxiation. All animals were subject to gross necropsy.
No deaths occurred as a result to treatment and no clinical signs of toxicity were observed. All animals showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy.
It can be concluded that 2-propen-1-amine, N-2-propen-1-yl, hydrochloride has an LD50 >2000 mg/kg body weight via the oral route.
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