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EC number: 241-629-2 | CAS number: 17647-86-8
- 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
LD50 (oral) > 2250 mg/kg bw (BASF AG, 1979)
LD50 (dermal) > 2000 mg/kg bw (BASF SE, 2015)
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:
- 1978-09-12 to 1978-09-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable study report
- Principles of method if other than guideline:
- according to BASF-internal standard
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: WIGA, Sulzfeld, Germany
- Weight at study initiation: males: 220 - 260 g; females: 180 - 190 g
- Fasting period before study: 15 to 20 hours before application
- Diet: standardized animal laboratory diet - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 21.5 and 50 % (G/V)
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2150 and 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: One female in the 5000 mg/kg group was found dead after one day.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 250 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- Male animals: no deaths after 14 days
Female animals: 2150 mg/kg: no deaths after 14 days; 5000 mg/kg: 1/5 after 14 days - Clinical signs:
- other: 5000 mg/kg: staggering, dyspnea, apathy, poor general state
- Gross pathology:
- Sacrificed animals: nothing abnormal detected
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 250 mg/kg bw
- Quality of whole database:
- scientifically acceptable study report
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-02-23 to 2015-2015-03-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- (1987)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- (2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- (1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bioassay Labor für biologische Analytik GmbH, Im Neuenheimer Feld 515-519, 69120 Heidelberg, Germany
- 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
- Source: Charles River Wiga GmbH, Germany
- Age at study initiation: Young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks)
- Weight at study initiation: males: 220.8 ± 6.9 g; females: 204.2 ± 7.3 g
- Housing: Single housing in Makrolon cage, type III
- Diet: ad libitum (VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- deionized
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Dorsal and dorsolateral parts of the trunk
- coverage: About 40 cm² (corresponds to at least 10% of the body surface)
- Type of wrap if used: air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing: Rinsing of the application site with warm water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 2.88 mL/kg bw
- Concentration (if solution): 80 g/100 mL - Duration of exposure:
- 24 hours
- Doses:
- 2300 mg/kg bw corresponding to an actual dose of 2000 mg/kg bw.
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Not performed.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed throughout the study period.
- Clinical signs:
- other: No systemic clinical signs were observed in both male and female animals. The following local effects were observed in male and female animals: Males: Well-defined erythema (grade 2) was noted in all male animals from study day 1 until study day 3, which
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in all animals (5 males and 5 females) examined on the last day of observation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- GLP and guideline compliant study report.
Additional information
Acute Oral Toxicity
In a study according to BASF internal standard procedures, the acute oral toxicity of the test substance following a single oral administration in Wistar rats was investigated (BASF AG, 1979). Two groups of 10 fasted animals (5 animals per sex and dose) were exposed to 2150 and 5000 mg/kg bw of unchanged test substance (45% solution) and observed for 14 days. One animal of the 5000 mg/kg bw dose group was found dead. All other animals survived until the end of the observation period. At the dose level of 2150 mg/kg bw no clinical signs were observed during the course of the study. The animals of the 5000 mg/kg bw group developed staggering, dyspnoe, apathy and were in a bad general state. The mean body weight increased within the normal range throughout the study period. No macroscopic findings were observed at necropsy. The acute oral LD50 of the test substance after single oral administration to rats is > 5000 mg/kg bw (LD50 of active ingredient = 2250 mg/kg bw).
Acute Dermal Toxicity
In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2300 mg/kg bw (actual dose of 2000 mg/kg bw taking the content of active ingredient at study start into account) of Potassium N,N-dimethylglycinate (as suspension in deionized water). The test substance was applied to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi-occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days.
No mortality occurred. No signs of systemic toxicity were observed. The following test item-related local effects were recorded during the whole course of the study (14 days):
- Very slight to well-defined erythema (grade 1 to 2)
- Very slight edema (grade 1)
- Scaling
- Incrustations
- Plaque-like incrustations beyond the application area in one female animal
- Erythema beyond the application area in one female animal
The mean body weight of the male animals increased within the normal range throughout the study period. The body weight of the female animals increased within the normal range throughout the study period with two exceptions. Two female animals showed stagnation of body weight during the first week, but the body weight increased within the normal range during the second week. As stagnation of body weight is generally known to occur as a consequence of the dermal application procedure in female animals, the body weight stagnation observed is considered to be unspecific.
No macroscopic pathologic abnormalities were noted in all animals examined at the end of the study. Accordingly, the acute dermal median lethal dose (LD50) was determined to be above 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
scientifically acceptable study report
Justification for selection of acute toxicity – dermal endpoint
GLP and guideline compliant study report.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance does not need to be classified and labelled for acute oral and dermal toxicity under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EC) No 2015/1221.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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