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EC number: 268-219-6 | CAS number: 68037-95-6 This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl amine and SDA Reporting Number: 11-029-00.
- 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:
- 1988-02-08 to 1988-03-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Amines, tallow alkyl
- EC Number:
- 263-125-1
- EC Name:
- Amines, tallow alkyl
- Cas Number:
- 61790-33-8
- IUPAC Name:
- 61790-33-8
- Reference substance name:
- Tallow Alkylamines
- IUPAC Name:
- Tallow Alkylamines
- Details on test material:
- - Name of test material (as cited in study report): Genamin TA 100 D
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Zucht
- Strain: Hoe: WISKf(SPF71)
- Age at study initiation:
- male ca. 7 weeks
- female ca. 8weeks
- Weight at study initiation:
- male mean = 176 g; min = 167 g, max = 189 g; sd = +-8g
- female mean = 175 g; min = 171 g, max = 181 g; sd = +-4g
- Randomized
- Fasting period before study: 16 h before application and 3-4 hours after application of the test substance
- Housing: fully air-conditioned in makrolon cages (type 4) on soft wood chips in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 1324 (Altromin-GmbH, Lage/Lippe) ad libitum
- Water (e.g. ad libitum): tap-water ad libitum
- Acclimation period: min 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +-3
- Humidity (%): 50 +- 20
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12
TEST ANIMALS
- Source: Hoe: WISKf (SPF71), Hoechst AG, Germany
- Age at study initiation: ca. 7 weeks (male animales); ca. 8 weeks (female animals)
- Weight at study initiation: 176g +/- 8g (male animals); 175g +/- 4g (female animals)
- Fasting period before study: ca. 16 hours prior and 4 hours after application
- Housing: Makrolon cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- - Concentration in vehicle: 20%, 25% (w/v)
- Doses:
- 2000 mg/kg body weight (male and female animals)
2500 mg/kg body weight (male animals only) - No. of animals per sex per dose:
- 5 male and 5 female (2000 mg/kg bw)
5 male (2500 mg/kg bw) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations once daily / Weighing once weekly
- Necropsy of survivors performed: yes
- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes/no - Statistics:
- Probit analysis
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- 0 out of 5 female animals at 2000 mg/kg body weight
1 out of 5 male animals at 2000 mg/kg body weight
1 out of 5 male animals at 2500 mg/kg body weight - Gross pathology:
- Dissection of the two male rats that died during the course of the study revealed bright scattered coloration of the liver and lungs. The gastrointestinal tract was filled with gas. The rats that were killed at the end of the observation period were free of macroscopic findings.
see annex 6.3 of attached study report for additional details
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, Genamin TA 100 D is not subject to labelling and classification requirements according to directive EC 1272/2008 with regard to acute oral toxicity
- Executive summary:
The acute oral toxicity of Genamin TA 100 D was investigated in rats using sesam oil as vehicle. 5 male and 5 female rats were administered the test compound by single-dose gavage at a dose levels of 2000 mg/kg body weight. A separate group of 5 male rats received an additional dose of 2500 mg/kg body weight by gavage. The observation period was 14 days. After administration of 2000 and 2500 mg/kg body weight one male animal died whereas all female animals survived treatment with 2000 mg/kg body weight. Both fatal intoxicated animals showed the following symptoms: bristled coat, squatting posture, stilted gait, irregular respiration and decreased spontaneous activity. At necropsy the following findings were revealed: Gastrointestinal tract filled with gas, bright scattered coloration of lung and liver. No clinical symptoms were observed at the end of the observation period. Based on the findings of this test the median lethal dosage (LD50) of Genamin TA 100 D in the male and female rat is greater 2000 mg/kg body weight.
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