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Diss Factsheets
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EC number: 947-965-2 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- The skin irritation potential was assessed by rthe results obtained in a dermal toxicity study.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 June 2015 - 23 June 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (2-carboxyethyl)({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl})azanium; [({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl}carbamoyl)methyl](dodecyl)dimethylazanium; ethanol
- IUPAC Name:
- (2-carboxyethyl)({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl})azanium; [({2-[(2-carboxyethyl)(2-hydroxyethyl)amino]ethyl}carbamoyl)methyl](dodecyl)dimethylazanium; ethanol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD / Crl: CD(SD)
- Details on test animals or test system and environmental conditions:
- Strain / Stock CD / Crl: CD(SD)
Supplier: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
Body weight (at dosing):Males: 213 - 223 g; Females: 206 - 234 g
Age (at dosing): Males: approx. 8 weeks; Females: approx. 9 weeks
Identification of animals: By coloured marks and cage label
Commercial diet, ssniff® R/M-H V1534 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany) served as food. Feeding was discontinued approx. 16 hours before administration; only tap water was then available ad libitum.
Periodic analysis of the food for contaminants based on EPA/USA is conducted at least twice a year by LUFA-ITL. Certificates of analysis of the composition and for contaminants were provided by the manufacturer and are included in the raw data.
Housing
Granulated textured wood (Granulat A2, J. Brandenburg, 49424 Goldenstedt, Germany) was used as bedding material for the cages. The cages were changed and cleaned twice a week.
Periodic analysis of the bedding material for contaminants based on EPA/USA is conducted at least once a year by LUFA-ITL (see Appendix 2 'Limitation for Contaminants in the Bedding Material').
During the 14-day observation period the animals were kept singly in MAKROLON cages (type III plus) at a room temperature of 22°C ± 3°C (maximum range) and a relative humidity of 55% ± 15% (maximum range). Deviations from the maximum range caused for example during cleaning procedures are dealt with in SOPs.
The rooms were lit (150 lux at approx. 1.50 m room height) and darkened for periods of 12 hours each.
Drinking water
Drinking water in bottles was offered ad libitum.
Drinking water is examined according to the 'Deutsche Trinkwasserverordnung 2011 [German Regulations on drinking water 2011] by the Hamburger Wasserwerke, 20539 Hamburg, Germany, at least four times a year (see Appendix 2 'Limitation for Contaminants in the Drinking Water').
In addition, drinking water samples taken at LPT are analysed by LUFA-ITL once a year for means of bacteriological investigations according to the 'Deutsche Trinkwasserverordnung 2011, Anlage 1' [German Regulations on drinking water 2011, Addendum 1].
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- The test substance was used as supplied. The application volume was 3.73 mL/kg b.w. as the density of the test item was 1.0731 g/mL.
The test item was an approx. 50% aqueous solution. A correction factor of 2 was employed. The concentration refers to the solid content (active ingredient). - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 2 weeks
- Number of animals:
- 5 animals/sex
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 5, 15, 30 min after administration, as well as 3, 6 and 24 hours after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology: changes of skin and fur, eyes and mucous membranes, respiratory and circulatory function, autonomic and central nervous system and somatomotor activity as well as behaviour pattern, were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Observations on mortality were made at least once daily to minimize loss of animals during the study. Individual body weights were recorded before administration of the test item and thereafter in weekly intervals up to the end of the study. Changes in weight were calculated and recorded.
The skin was observed for the development of erythema and oedema.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: visual inspection
- Basis:
- other: all animals in test
- Time point:
- other: daily until end of test
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Summarized results
Symptoms/Criteria |
Test substance 2000mg/kg b.w. (n = 5) |
|
|
males |
females |
Clinical signs |
none |
none |
Skin reactions |
none |
none |
Mortality within 6 h within 27 h within 7 d within 14 d |
0 0 0 0 |
0 0 0 0 |
Mean body weight (in g) start |
217.6 |
218.2 |
After 7 days |
275.8 (+ 26.7) |
238.6 (+ 9.3) |
After 14 days |
331.8 (+ 52.5) |
263.8 (+ 20.9) |
Inhibition of body weight gain |
none |
None |
Necropsy findings |
none |
none |
In brackets: body weight gain in %, compared to the start value
The dose level refers to the active ingredient
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- No skin reactions were observed at the application site 24 hours after application until end of observation period (2 weeks).
- Executive summary:
There is no evidence for a skin irritating potential of Amines, C12-16 alkyl dimethyl, reaction products with ethyl chloroacetate, 2-(2-aminoethylamino)ethanol and 2-propenoic acid from an acute dermal toxicity study (OECD guideline 402). Groups of 5 male and female young adult rats (Rattus norvegicus) were dermally exposed to the test substance for 24 hours under an occlusive dressing. The applied dose of 2000 mg/kg bw (related to a.i.) is equivalent to an average concentration of 29.1 mg/cm² and 29.4 mg/cm² for males and females, respectively. Calculation is based on mean applied volume males: 0.81 mL, females: 0.82 mL; densitiy 1.0731 g/mL and area of exposue 5 x 6 cm.
No signs of irritation were recorded during the 14 day observation period.
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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