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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September / October 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- At the time the study was conducted the Guinea Pig Maximation was the accepted standard test for skin sensitisation.
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
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Fa. Winkelmann Versuchstierzucht
- Age at study initiation: -
- Weight at study initiation: male 359 - 447 g, female 334 - 425 g
- Housing: collective housing up to a maximum of 5 animals per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To:-
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Pilot experiment:
Intradermal: 0.1 ml of 5.0 %, 1 %, 0.5 % and 0.1 % dilution in water.
Dermal: soaked patch with 100 %,50 %, 25 % , 10%, 5%, 1% and 0.5 % of the test substance in water.
Main study:
Intradermal: 0.1 ml of 1 % dilution in water.
Dermal: soaked patch with the undiluted test substance.
Challenge: soaked patch with 5 % and 1 % dilution in water.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Pilot experiment:
Intradermal: 0.1 ml of 5.0 %, 1 %, 0.5 % and 0.1 % dilution in water.
Dermal: soaked patch with 100 %,50 %, 25 % , 10%, 5%, 1% and 0.5 % of the test substance in water.
Main study:
Intradermal: 0.1 ml of 1 % dilution in water.
Dermal: soaked patch with the undiluted test substance.
Challenge: soaked patch with 5 % and 1 % dilution in water.
- No. of animals per dose:
- 10 male / 10 female
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2: intradermal and epicutaneous
- Exposure period:
- Test groups: 10 male / 10 female
- Control group: 10 male / 10 female
- Site: shoulders
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Exposure period: 24 h
- Test groups: 2
- Control group: 1
- Site: flanks
- Concentrations: 5 % and 1 % dilutions in water
- Evaluation (hr after challenge): 24h and 48h after patch removal
OTHER: - Challenge controls:
- 2 control groups (1 % and 5 % test substance concentration)
- Positive control substance(s):
- yes
- Remarks:
- 2.4 dinitrochlorobenzene and benzocaine
Results and discussion
- Positive control results:
- The reaction to the positive control substances 2.4 dinitrochlorobenzene (strong sensitizer) and benzocaine (moderate sensitizer) is tested periodically. The last test with an acceptable level of response to each of these substances was performed in October 1991.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 % dilution
- No. with + reactions:
- 18
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 % dilution. No with. + reactions: 18.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 % dilution
- No. with + reactions:
- 19
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 % dilution. No with. + reactions: 19.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 % dilution
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 % dilution. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 % dilution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 % dilution. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 % dilution
- No. with + reactions:
- 17
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5 % dilution. No with. + reactions: 17.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5 % dilution
- No. with + reactions:
- 14
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5 % dilution. No with. + reactions: 14.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1 % dilution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1 % dilution. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 % dilution
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 % dilution. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- According to the grading scheme of Magnusson and Kligman, the test article “REWOTERIC QAM 50” is classified as a “mild sensitizer”. The sensitisation rate at 24 h was 10 % with the 1 % dilution. The 5 % dilution caused skin reactions in 90 % of the test group animals and in 85 % of the control group animals. From the results it is assumed that the sensitization rate is < 30 % for both concentrations and the test substance is regarded as non-sensitising.
- Executive summary:
The test substance was tested regarding its skin sensitisation potential. The test was performed according to the protocol of Magnusson and Kligman, in which adjuvant is used to elicit an immunologic reaction. The test protocol is in compliance with the OECD Guideline for the Testing of Chemicals No. 406 Skin Sensitisation (1992). The maximum compatible doses for the intradermal and dermal application as well as the subirritative dose for the challenge were determined in a pilot experiment. In the main experiment two test groups of ten (10) male and ten (10) female guinea pigs of the strain "Pirbright White" were treated intradermally with 0.1 ml of a 1 % dilution of the test substance in water. Two control groups of ten (10) male and ten (10) female animals received the vehicle only. For the dermal induction the undiluted test substance or the vehicle only (control group) was used. In the challenge application 5 % or 1 % dilutions of the test substance in water were applied to the flanks of the animals. Body weight development of the animals was positive and within normal ranges.
In the challenge visible changes of the skin ( erythema and swelling grading 1 -3 ) were observed 24 hours after patch removal in
90 % (18/20) of the 5 % test group and in 85 % (17/20) of the 5 % control group animals indicating a distinct irritating potential of the 5 % concentration of the test substance. In the 1 % test group 10 % (2/20) of the animals showed only very slight erythema at the treated skin site after 24 hours. 48 h after the challenge these skin reactions were not observed anymore. In the corresponding 1 % control group no skin reaction was observed 24 hours and 48 hours after the challenge.
According to the grading scheme of Magnusson and Kligman, the test substance is classified as a “mild sensitizer”. The sensitisation rate was 10 % at 24 h and 0 % at 48 h with the 1 % dilution. The 5 % dilution caused skin reactions both in the test group animals and in the corresponding control group. From the results it is assumed that overall the sensitization rate is < 30 % and the test substance is regarded as non-sensitising.
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