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EC number: 951-974-7 | CAS number: -
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1986-03-26 to 1986-04-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)
- Cas Number:
- 1079184-43-2
- Molecular formula:
- n.a. (UVCB)
- IUPAC Name:
- 1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)
- Details on test material:
- - Name of test material (as cited in study report): FV base E2819.01
- Diethylester dimethyl ammonium chloride
- Substance type: Waxy
- Physical state: White Solid
- Analytical purity: confidential detail
- Impurities (identity and concentrations): None
- Composition of test material, percentage of components: confidential detail
- Isomers composition: NA
- Purity test date: NA
- Lot/batch No.: E-2819.01
- Expiration date of the lot/batch: 1986-06
- Stability under test conditions: Not available
- Storage condition of test material: Room temperature
- Other: None
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm
- Age at study initiation: Not available
- Weight at study initiation: 2.02 - 3.28 kg
- Fasting period before study: Not available
- Housing: Single caging in battery of cages size: 40 cm high, 45 cm wide, 50 cm long with paper roll disposal system
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2 degree C
- Humidity (%): 50-85%
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12 hours daily, light-dark cycle
IN-LIFE DATES: From: 1986-03-26 To: 1986-04-04
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: Oleum arachidis
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal trunk
- % coverage: 15 X 10 cm
- Type of wrap if used: The treated area was covered with gauze pads and the body was wrapped into a rubberized cloth.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): If necessary, with lukewarm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): 40% a.i.
- Constant volume or concentration used: no
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit): Not available
- Concentration (if solution): Not available
- Lot/batch no. (if required): Not available
- Purity: Not available - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw (male/female)
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily for observations and Body weights were taken on first and fourteenth day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- No mortality
- Clinical signs:
- other: The test substance did not induce any clinical-toxicological symptoms. Slight to moderate erythema and mainly moderate edema were observed at the treatment sites up to day 3 which resolved afterwards.
- Gross pathology:
- Necropsies performed on all animales at termination exhibited no gross pathological findings.
- Other findings:
- - Organ weights: None
- Histopathology: None
- Potential target organs: None
- Other observations: None
Any other information on results incl. tables
Skin assessments made at 24 hrs, 3, 7 and 14 days revealed that 2 mg/kg MDEA-Esterquat produced moderate skin irritation. Slight (3/6 rabbits) to moderate (3/6 rabbits) erythema and moderate edema at the 24 hour reading; slight (5/6 rabbits) to moderate (1/6 rabbits) erythema and slight (3/6 rabbits) to moderate (3/6 rabbits) at day 3. These skin responses resolved at day 7. No atonia, desquamation, fissuring, eschar or exfloliation was observed in the animals in this study.
Erythema and Edema observations at Treated Site
Animal # | Erythema (24 hr) | Edema (24 hr) | Erythema (3 days) | Edema (3days) | Erythema (7days) | Edema (7 days) | Erythema (14 days) | Edema (14 days) |
93 (M) | 2 | 2 | 1 | 2 | 0 | 0 | 0 | 0 |
72 (M) | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
83 (M) | 1 | 2 | 1 | 2 | 0 | 0 | 0 | 0 |
791 (F) | 2 | 2 | 2 | 1 | 0 | 0 | 0 | 0 |
792 (F) | 2 | 2 | 1 | 1 | 0 | 0 | 0 | 0 |
799 (F) | 1 | 2 | 1 | 2 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category V
- Remarks:
- Migrated information Criteria used for interpretation of results: other: GHS Regulation EC No 1272/2008
- Conclusions:
- MDEA-Esterquat C16-18 and C18 unsatd. is practically non - toxic.
- Executive summary:
In an acute dermal toxicity study (comparable to OECD guideline 402), groups of 3 male and female New Zeeland White rabbits were dermally exposed to MDEA-Esterquat C16-18 and C18 unsatd. (40 % a.i) in oleum arachidis for 24 hours to10 x 15 cm of body surface area at doses of 2000 mg/kg bw. Animals then were observed for14 days.
Dermal LD50 Males > 2000 mg/kg bw
Females > 2000 mg/kg bw
Combined > 2000 mg/kg bw
No mortality occurred in this limit test.
MDEA-Esterquat C16-18 and C18 unsatd. is practically non – toxic in this study.
There were no treatment related clinical signs, necropsy findings or changes in body weight.
Slight (1) to moderate (2) erythema and mainly moderate (2) edema with partly decreased intensity were observed at the treatment sites from 24 hours up to the 72 hours after treatment and were fully reversible within 7 days. The mean score were 1.3 for erythema and 1.75 for edema (after 24 and 72 hours). The applied scores of 1 and 2 for erythema and edema were comparable to the scores of the Draize method.
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