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EC number: 620-174-7 | CAS number: 1079184-43-2
- 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:
- 1986-03-17 to 1986-04-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- other: Up down followed by limit test at 10,000 mg/kg bw
- Limit test:
- yes
Test material
- Reference substance name:
- Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides
- Cas Number:
- 1079184-43-2
- Molecular formula:
- n.a. (UVCB)
- IUPAC Name:
- Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Physical state: Solid
- Purity test date: 1986-01-22
- Expiration date of the lot/batch: 1986-06-01
- Storage condition of test material: Room temperature
Test animals
- Species:
- rat
- Strain:
- other: BCR:WISW
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Firma WickeImann, Versuchstierzucht, 4791 Borchen 1, Gartenstraße 300
- Age at study initiation: Not available
- Weight at study initiation: Male= 200 to 227 gm, female= 150 to 160.8 gm
- Fasting period before study: 18-20 hours
- Housing: Collection caging in Makrolon type III/ max.5 rats
- Diet (e.g. ad libitum): Ssniff-R Alleindiät fur Ratten pellets
- Water (e.g. ad libitum): ad libitum,Aqua fontana as for human consumption
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 2°C
- Humidity (%): 50 to 85 % different from guideline (30 - 70 %)
- Air changes (per hr): Not avialable
- Photoperiod (hrs dark / hrs light): 12 hours daily
IN-LIFE DATES: From: 1986-03-17 To: 1986-04-11
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Oleum arachidis
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 40 % dilution in oleum arachidis
- Amount of vehicle (if gavage): Not applicable
- Justification for choice of vehicle: Not available
- Lot/batch no. (if required): E-2819.01
- Purity: 80 % DEEDMAC
MAXIMUM DOSE VOLUME APPLIED: 5.7 ml
DOSAGE PREPARATION (if unusual): None
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Not applicable - Doses:
- 500 mg /kg bw
10000 mg /kg bw - No. of animals per sex per dose:
- 1 animal for 500 mg/kg bw
1 animal for 10000 mg/kg bw (up and down method)
5 males and 5 females for 10000 mg/kg bw (limit test) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 4 days for the preliminary study and 14 days for the main study
- Frequency of observations and weighing: Daily for observation ,Weighed at day 0 and at day 14 .
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Not applicable
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- No mortality was observed during the study at a limit dose of 10000 mg/kg bw.
- Clinical signs:
- other: Two of the treated animals showed slight piloerection during the first hour after application. Afterwards, they showed a normal disposition.The other animals appeared normal during the entire testing period.
- Gross pathology:
- No abnormality was observed during terminal necropsy.
- Other findings:
- - Organ weights: none
- Histopathology: None
- Potential target organs: None
- Other observations:None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of MDEA-Esterquat C16-18 and C18 unsatd. is >10000 mg/kg bw. This test material is considered to be practically non-toxic.
- Executive summary:
In an acute oral toxicity study comparable to now deleted OECD guideline 401, groups of fasted,WISW rats 5 males and 5 females were given a single oral dose of
MDEA-Esterquat C16-18 and C18 unsatd. (40 % w/w a.i.) in oleum arachidis at a dose of 10 000 mg/kg bw.
oral LD50 Males > 10 000 mg/kg bw
Females > 10 000 mg/kg bw
Combined > 10 000 mg/kg bw
No mortality occurred in this limit test.
MDEA-Esterquat C16-18 and C18 unsatd. is practically non-toxic based on the LD50 combined of > 10 000 mg/kg bw.
There were no treatment related clinical signs, necropsy findings or changes in body weight. A slight piloerrection was observed in 2/10 animals during the first hour after application. Afterwards they showed a normal disposition.
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