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EC number: 276-339-5 | CAS number: 72102-40-0
- 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:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The in vivo study data were obtained in studies performed before any in vitro sensitization tests tests had been validated and accepted for regulatory purposes. Additionally, literature data demonstrates that an LLNA method is unreliable for surfactant substance, and may provide false positive results [1]. Therefore, an LLNA method is not deemed reliable for assessing the skin sensitisation of the substance.
[1]: Evaluating the sensitization potential of surfactants: Integrating data from the local lymph node assay, guinea pig maximization test, and in vitro methods in a weight-of-evidence approach. Ball et al. Regulatory Toxicology and Pharmacology 60 (2011) 389–400
Test material
- Reference substance name:
- Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate
- EC Number:
- 304-990-8
- EC Name:
- Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate
- Cas Number:
- 94313-91-4
- Molecular formula:
- C17H35N2O.CH3O4S
- IUPAC Name:
- methyl sulfate;trimethyl-[3-(undec-10-enoylamino)propyl]azanium
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Reference substance name:
- Ethanol
- EC Number:
- 200-578-6
- EC Name:
- Ethanol
- Cas Number:
- 64-17-5
- Molecular formula:
- C2H6O
- IUPAC Name:
- Ethyl alcohol
- Test material form:
- solid
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- male
- Details on test animals and environmental conditions:
- Test animals
- Age at study initiation: no data
- Weight at study initiation: 300 - 430 g
- Housing: max. 2 animals in one cage, Macrolon cages
- Diet: ad libitum; Ssniff-G (Alleindiät für Meerschweinchen), Ssniff Versuchstier-Diaten GmbH, 4770 Soest/Westfalen
- Water: ad libitum
- Acclimation period: 9 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23
- Humidity (%): 40-70
- Air changes (per hr): 10 per h
- Photoperiod: 12 h daily
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Dose range finding study: intradermal: 0.1%, 0.5%, 1%, 5%
- Day(s)/duration:
- 1 d (24 h)
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Dose range finding study: epicutaneous: 5%, 20%, 50%, 100%
- Day(s)/duration:
- 1 d (24 h)
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Main study: intradermal: 5%
- Day(s)/duration:
- 2 d (48 h)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Main study: epicutaneous: 20%
- Day(s)/duration:
- 2 d (48 h)
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Challenge: epicutaneous: 5%
- Day(s)/duration:
- 1 d (24 h)
- Adequacy of challenge:
- other: subirritative concentration based on pre-test
- No. of animals per dose:
- Range finding: 6 animals (4 epicutaneous, 2 intradermal)
Main Study: 10 animals (test group), 5 animals (control group) - Details on study design:
- The test was performed according to a modified version of the Magnusson-Kligman Guinea Pig Maximisation Test. This investigation was performed according to HLD test plan P 3/152, 3-rd revision as well as according to the recommended guidelines of the USA Interagency Regulatory Liaison Group (IRLG, January, 1981).
Range finding tests:
Four animals were treated dermally in a preliminary study under occlusiv conditions (exposure period 24 h) with the following concentrations of the sample: epicutaneous: 5%, 20%, 50%. Reading 3 h p.a.
Two animals were treated intradermal: 0.1%, 0.5%, 1%, 5% (aqueous solution). Reading 24 h p.a.
Main study
(A) Induction exposure
(A.1) Intradermal injection – Performed on Test Day 1
Based on the pretest results, the test item concentration of 5% was selected for intradermal induction in the main study. An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 mL/site) were made just within the boundaries of a 4 x 6 cm area in the clipped region as follows:
- Test groups:
1) 0.1 mL Complete Adjuvant (50 % v/v in water for injection) (Bactoadjuvant Completa H 37 Ra, Difco Laboratories, Detroit, Michigan)
2) 0.1 mL 5 % v/v test substance in Aqua dest.
3) 0.1 mL 5 % v/v test substance in Aqua dest. emulsified in 50 % Adjuvant
- Control group:
1. 0.1 mL Complete Adjuvant (50 % v/v in water for injection)
2. 0.1 mL aqua dest
3. 0.1 mL Complete Adjuvant (50 % v/v in aqua dest.)
(A.2) Epidermal induction - Performed one week after intradermal injection
- Volume: 0.5 mL
- Exposure period: 48 h
- Test groups: 10
- Control group: 5
- Site: the same site as for intradermal injection
- Frequency of applications: 1
- Concentrations: 20%
(B) Challenge exposure
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after induction
- Exposure period: 24 h
- Control group: aqua dest.
- Concentrations: 5 %
- Evaluation (h after challenge): 48 h, 72 h - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reaction
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reaction
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no skin reaction
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no skin reaction
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Remarks:
- (non-sensitising)
- Conclusions:
- Under study conditions, the test substance was determined to be non-sensitising to skin.
- Executive summary:
A study was conducted to determine skin sensitisation potential of the test substance, 'C11-unsatd. AAP TMA-MS' (active: 47%) in a guinea pig maximisation test (GPMT), according to a method similar to OECD Guideline 406. The test was performed in 15 (10 test and 5 control) male young adult Pirbright-White guinea pigs. The maximum compatible concentrations which led to slight irritation after intradermal and dermal application as well as the sub-irritative dose for the challenge application were determined in pre-tests. In the main test, one treated group of ten males received the test substance in a 50% mixture of Complete Adjuvant (50 % v/v in water for injection) on Day 1 by intradermal injections in the interscapular region at the concentration of 5% and on Day 8 by topical application to the clipped interscapular region at 20% (aqueous solutions). A control group of five males received water (vehicle) on Day 1 and Day 8 to the interscapular region. The induction phase was followed by a 14 d rest period. For challenge test, the test substance was applied topically on Day 22 to the posterior right flank at 20%. Cutaneous reactions were evaluated 48 and 72 h after challenge test. The sensitisation rate, i.e. the number of animals showing an allergic response expressed as a percentage of the total number of animals, was calculated. No allergic skin reactions were observed in test animals 48 and 72 h after the challenge exposure. No findings were observed in control animals. Therefore, the sensitisation rate was determined to be 0% for test substance. Under the study conditions, the test substance was concluded to be non-sensitising to the skin of guinea pigs (Meisel, 1983).
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