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EC number: 270-418-8 | CAS number: 68439-75-8 This substance is identified by SDA Substance Name: C12-C18 dialkyl methyl amine and SDA Reporting Number: 16-043-00.
- 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
Endpoint summary
Administrative data
Description of key information
The acute oral toxicity of the substance was assessed using:
- An acute oral toxicity limit test performed in rats according to OECD 401 guideline and Good Laboratory Practices (Hoechst, 1990).
The substance is of low acute toxicity following oral exposure:
The oral LD0 was found to be greater than 2000 mg/kg bw in both sexes.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1990-01-17 to 1990-02-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentations. Only short report available.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Reliability scoring based on 1987 guideline for test n°401
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 198 g for male, 179 g for female - Route of administration:
- oral: gavage
- Vehicle:
- other: sesam oil
- Details on oral exposure:
- - The test substance was administrated as a 20 % (w/v) mixture in sesame oil at a constant volume of 10 ml/kw to yield a dose level of 2000 mg/kg
- Sesame oil comes from Mainlan pharmaceutical factory Ltd - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- All animals were observed for 14 days following dosing. Body weights were also recorded.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Statistics:
- none
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Mortality:
- No deaths were observed during the study.
- Clinical signs:
- other: The animals showed impaired breathing and motion, as well as blood-colored, crusty snouts. The symptoms were reversible by day 4.
- Gross pathology:
- No abnormalities were observed at macroscopic examination.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC) and Directive 67/548/EEC
- Conclusions:
- Under these experimental conditions, the tested substance Genamin CS 301 is not classified according to CLP (Reg. n° 1272/2008/EC) and directive 67/548/EEC.
- Executive summary:
The objective of this study was to evaluate the toxicity of Genamin CS 301 following a single oral administration in rats according to the OECD guideline 401 and to the EU Method B.1. The study was conducted in compliance with the principles of Good Laboratory Practice regulations.
Genamin CS 301 was prepared in sesame oil and was administered by gavage under a dosage-volume of 10 ml/kg bw to 2 groups of 5 male and 5 female rats.The experiment was performed at the limit dose level of 2000 mg/kg bw.
Clinical signs, mortality and body weight were checked for a period of 14 days following the single administration of the test item. All animals were subjected to necropsy.
At the dose-level of 2000 mg/kg, no mortality and no effects on body weight gain were observed. The animals showed impaired breathing and motion, as well as blood-colored, crsuty snouts. The symptoms were reversible by day 4. There were no apparent abnormalities at necropsy.
Under these experimental conditions, the oral LD0 of Genamin CS 301 was equal or higher than 2000 mg/kg bw in rats.
Reference
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The acute oral toxicity study was reliable with some restrictions due to limited information mentioned in the report.
The Hoechst study (1990) was performed in rats according to the OECD guideline 401 and to the EU Method B.1. The study was conducted in compliance with the principles of Good Laboratory Practice regulations.
The substance was prepared in sesame oil and was administered by gavage under a dosage-volume of 10 ml/kg bw to 2 groups of 5 male and 5 female rat. The experiment was performed at the limit dose level of 2000 mg/kg bw.Clinical signs, mortality and body weight were checked for a period of 14 days following the single administration of the test item. All animals were subjected to necropsy.
At the dose-level of 2000 mg/kg, no mortality and no effects on body weight gain were observed. The animals showed impaired breathing and motion, as well as blood-colored, crusty snouts. The symptoms were reversible by day 4. There were no apparent abnormalities at necropsy.
The oral LD50 was found to be higher than 2000 mg/kg bw in rats.
Justification for classification or non-classification
According to the criteria laid down in EU regulation (EC) n° 1272/2008/EC (CLP) and EU directive67/548/EEC, the substance is not classified for acute toxicity.
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