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Diss Factsheets
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EC number: 947-953-7 | 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-08-01 to 2017-09-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of Reaction product of 1-chloro-3-{[1-chloro-3-(dodecyloxy)propan-2-yl]oxy}propan-2-ol with methyl diethanolamine and [3-(dodecyloxy)-2-hydroxypropyl]bis(2-hydroxyethyl)methylammonium chloride
- IUPAC Name:
- Reaction mass of Reaction product of 1-chloro-3-{[1-chloro-3-(dodecyloxy)propan-2-yl]oxy}propan-2-ol with methyl diethanolamine and [3-(dodecyloxy)-2-hydroxypropyl]bis(2-hydroxyethyl)methylammonium chloride
- Test material form:
- other: solid, very viscous yellow paste
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- HUSBANDRY
The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central airconditioning.
The average room temperature was maintained within the range of 23.1 ± 0.5° C, relative humidity within 55.4 ± 3.3 %.
The light regimen was set to a 12-hour light/12-hour dark cycle.
The sanitation was performed according to the standard operation procedures.
DIET
A laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered in recommended doses each day approximately at the same time.
WATER
The animals received tap water for human consumption. Supply of drinking was unlimited.
BEDDING
Lignocel S3/4, Lufa - ITL GmbH, Germany
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- The test item was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following the period of fasting, the animals were weighted and the test item was administered. After the test item had been administered, food was withheld for further 3-4 hours.
- Doses:
- - limit dose of 2000 mg/kg bw (step 1 and 2)
- 300 mg/kg bw (step 3 and 4) - No. of animals per sex per dose:
- - step 1, 2, 3 and 4: 3 females per step (total 12 females)
- Control animals:
- no
- Details on study design:
- OBSERVATIONS
Clinical observations
The animals were observed individually immediately after the administration of the test item and then 0.5, 1, 2, and 4 hours later. Then each animal was inspected daily for the next 14 days. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor activity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Body Weights
Individual weights of animals were determined shortly before the test item was administered and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.
Necropsy
All test animals were subjected to gross necropsy and result were recorded for each animal. - Statistics:
- n.a.
Results and discussion
- Preliminary study:
- n.a.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 5/6 animals at dose of 2000 mg/kg bw
0/6 animals at the dose of 300 mg/kg - Clinical signs:
- other: - 2000 mg/kg bw: test item-related mortality in females treated with the test item in dose of 2000 mg/kg body weight was observed during the 24 hours. Lethargy was observed in all animals between 1-4 hours post-treatment. On post-treatment Day 1 animals N
- Gross pathology:
- Animals No 2 and 3 (dose 2000 mg/kg) could not be necropsied because cadavers were autolysed.
Alopecic place behind the ears was registered in animal surviving the 14-day observation period.
All animals treated with dose of 300 mg/kg body weight were necropsied.
During necropsy, no macroscopic findings were noticed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of the test item is higher than 300 mg/kg bw and lower than 2000 mg/kg bw after single oral administration to female Wistar rats.
- Executive summary:
The purpose of the study was to evaluate the potential toxic effect of the test item when administered as a single oral dose to Wistar rats. The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used. The test was performed according to GLP regulations.
A limit dose of 2000 mg/kg body weight was used as a starting dose. One group of 3 females was dosed. Test item-related mortality was not observed within 24 hours and therefore in a next step 3 females were treated with the same dose. Test item-related mortality was observed on Day 5 after administration in the animals of the first step and on Day 1 and Day 2 in the animals of the second step. In the third step another 3 females were treated at the dose of 300 mg/kg body weight. All females survived 24 hours and thereafter 3 females (fourth step) were treated with the dose of 300 mg/kg body weight.
The test item was administered to 6 females at dose of 2000 mg/kg body weight caused death of 5/6 animals. Lethargy was observed during the observation period. Alopecic place behind the ears was registered in the animal surviving the 14-day observation period. Six of six females survived the dose of 300 mg/kg. Piloerection was observed during the first 4 hours and no signs of toxicity within the 14-day observation period thereafter in females treated with dose of 300 mg/kg body weight. Body weight stagnation was observed between week 1 and week 2. During necropsy, no macroscopic findings were observed.
The LD50 of the test item is higher than 300 mg/kg body weight and lower than 2000 mg/kg body weight after single oral administration to Wistar rats.
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