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EC number: 627-132-7 | CAS number: 1227096-04-9
- 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:
- from 1988-02-08 to 1988-02-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- 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
Test material
- Reference substance name:
- N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- EC Number:
- 627-132-7
- Cas Number:
- 1227096-04-9
- Molecular formula:
- No molecular formula
- IUPAC Name:
- N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- Test material form:
- liquid
- Details on test material:
- - Chemical name: N-C16-18 (even numbered)-alkyl-N-methyl, C16-18 (even numbered)-alkyl-1-amine
- EC number: 627-132-7
“Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.”
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: about 170 g
- Acclimation period: > 5 days
- Source: Hoechst AG, Kastengrund, SPF-Zucht
- Age at study initiation: 6 weeks (male) and 8 weeks (female)
- Acclimation period: at least five days
- Diet : ad libitum with Altromins 1324, except between 16 hours before and 4 hours after the test compound administration (no food)
- Water : ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature 22+/-3°C
- Humidity: 30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesam oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% w/v
- Amount of vehicle (if gavage): dose volumes were calculated from the fasting body weights of the rats and the selected dose volume was 10 ml/kg
body weight.
-The test substance was dissolved in sesame oil warmed to 35 °C. - 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
- Frequency of observations and weighting: once daily and weighing at 0, 7 and 14 days after exposure
- Necropsy of survivors performed: yes - Statistics:
- none
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Mortality:
- No deaths were observed during the study.
cf table 1 in results and discussions free text - Clinical signs:
- other: No systemic clinic signs were observed during the study at the dose-levels of 2000 mg/kg bw.
- Gross pathology:
- No abnormalities were observed at macroscopic examination.
Any other information on results incl. tables
Summarized results:
Table 1:Summarized results of cumulative mortality by sex
Acute oral toxicity, limit test, cumulative mortality | ||||
Day | Dose (mg/ kg bw) | Sex | Dose (mg/ kg bw) | Sex |
2000 | F | 2000 | M | |
Cumulative mortality | Cumulative mortality | |||
0 | 0/5 | 0/5 | ||
1 | 0/5 | 0/5 | ||
2 | 0/5 | 0/5 | ||
3 | 0/5 | 0/5 | ||
4 | 0/5 | 0/5 | ||
5 | 0/5 | 0/5 | ||
6 | 0/5 | 0/5 | ||
7 | 0/5 | 0/5 | ||
8 | 0/5 | 0/5 | ||
9 | 0/5 | 0/5 | ||
10 | 0/5 | 0/5 | ||
11 | 0/5 | 0/5 | ||
12 | 0/5 | 0/5 | ||
13 | 0/5 | 0/5 | ||
14 | 0/5 | 0/5 |
Table 2:Summarized results for body weight
Acute oral toxicity, limit test, 2000 mg/kg bw | |||||
Sex | Mean body weight in grams | ||||
Day 0 | Day 7 | Day 14 | |||
M | 170 | 233 | 248 | ||
M | 173 | 244 | 261 | ||
M | 171 | 235 | 250 | ||
M | 171 | 237 | 257 | ||
M | 170 | 244 | 261 | ||
F | 175 | 198 | 205 | ||
F | 170 | 200 | 209 | ||
F | 177 | 209 | 232 | ||
F | 176 | 202 | 220 | ||
F | 171 | 203 | 215 |
Applicant's summary and conclusion
- 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 SH 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 SH 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 SH 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.Based on a preliminary study indicating no deaths in 1 male and 1 female rats at 2000 mg/kg bw, the main 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, no clinical signs and no effects on body weight gain were observed. There were no apparent abnormalities at necropsy.
Under these experimental conditions, the oral LD0 of Genamin SH 301 was equal or higher than 2000 mg/kg bw in rats.
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