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EC number: 454-210-6 | CAS number: 13106-24-6
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline Study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- reduced number of animals in both, control and test group
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- other: Pirbright White, Dunkin Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Strain/Quality: Pirbright White, Dunkin Hartley Crl: (HA)BR [SPF]
Origin: Charles River GmbH - Wiga, Kisslegg, FRG
Age of the animals: Young adult animals
Bodly weight range at the beginning of the study: 332 - 367 g
Acclimatization period: 7 days before the beginning of the study in the laboratory for dermal toxicity.
Air conditions: The animals were housed in fully air-conditioned rooms in which a central air-conditioning system ensured a temperature in the range of 21 - 25°C and a relative humidity in the range of 30 - 70%. Deviations from these specifications that would have had an adverse effect on the test results did not occur.
Illumination period: 12 h light (6.00 a.m. - 6.00 p.m.); 12 h darkness (6.00 p.m. - 6.00 a.m.)
Type of cage: Makrolon, type IV
No. of animals per cage: 5
Identification of the animals: Ear tattoo
Type of diet: Kliba Labordiät (Kaninchen-Meerschweinchen-Haltungsdiät) ad libitum. Supplier: Firma Klingentalmühle AG, Kaiseraugst, Switzerland
Watering: Tap water ad libitum
Bedding: Granulat Type 3/4- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: test substance 5% in 0.9% aqueous NaCl-solution or in Freund's adjuvant / 0.9% aqueous NaCl-solution (1 : 1)
Percutaneous induction: test substance 50% in aqua bidest.
Challenge: test substance 25% in aqua bidest.- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: test substance 5% in 0.9% aqueous NaCl-solution or in Freund's adjuvant / 0.9% aqueous NaCl-solution (1 : 1)
Percutaneous induction: test substance 50% in aqua bidest.
Challenge: test substance 25% in aqua bidest.- No. of animals per dose:
- Control: 5 per control group (challenge control+negativ control)
Test group: 10- Details on study design:
- Induction:
Intradermal induction: 6 intradermal injections in groups of two per animal were given.
Injections for the control groups: A) front row 2 injections each of 0.1 mL Freund's adjuvant without test substance emulisified with 0.9%-aqueous NaCl-solution in a ratio of 1 :1
B) middle row: 2 injections each of 0.1 mL of the undiluted vehicle
C) back row: 2 injections each of 0.1 mL of a 50% formulation of the vehicle without test substance emulsified with Freund's adjuvant / 0.9% aqueous NaCl-solution (1 :1)
Injections for the test group:
A) front row: 2 injections each of 0.1 mL Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCl-solution in a ratio of 1 :1
B) middle row: 2 injections each of 0.1 mL of a test substance formulation in an appropriate vehicle at the selected concentration.
C) back row: 2 injections each of 0.1 mL Freund's adjuvant/ 0.9% aqueous NaCl-solution (1 : 1) with test substance at the selected concentration.
Site of application: - shoulder
No. of animals: - 2 per test substance concentration
Reading: - 24 h after the beginning of application
Percutaneous induction:
Peroutaneous induction was carried out one week after intradermal induction.
1 mL of the test substance formulation was applied to each animal. The control animals were not treated since the distilled water used as vehicle was not expected to influence the result of the study.
Duration of exposure: - 48 hours
Site of application: - shoulder, same area as in the case of the previous intradermal application
Readings: -48 h after the beginning of application
Challenge
The challenge was performed 14 days after the percutaneous induction.
Amount applied: 0.5 mL of the test substance formulation was applied to each animal.
- The test group and control group 1 were treated with the test substance formulation (control group 2 remained untreated).
Duration of exposure: - 24 hours
Site of application: - intact flank
Readings: -24 and 48 h after the removal of the patch- Challenge controls:
- Control group 1
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge control
- Dose level:
- 25% (0.5 ml)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge control. Dose level: 25% (0.5 ml). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge control
- Dose level:
- 25% (0.5 ml)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control. Dose level: 25% (0.5 ml). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% (0.5 ml)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% (0.5 ml). No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% (0.5 ml)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% (0.5 ml). No with. + reactions: 0.0. Total no. in groups: 10.0.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There is one reliable and relevant study available investigating the skin sensitizing potential of 1-Butanaminium, N,N-dibutyl-N-methyl-, methyl sulfate.
OECD Guideline similar Study:
The substance 1-Butanaminium, N,N-dibutyl-N-methyl-, methyl sulfate was tested for its sensitizing effect on the skin of the guinea pig in the MaximizationTest based on the method of Magnusson and Kligman (similar to OECD 406) under GLP. The intradermal induction with 5% test substance preparations caused moderate and confluent erythema with swelling in all test group animals. After the percutaneous induction with a 50% test substance preparation incrustation, partially open (caused by the intradermal induction) could be observed in addition to moderate and confluent erythema with swelling in all test group animals. A challenge was performed 14 days after the percutaneous induction. The number of animals with skin findings after the challenge (Test substance 25% in aqua bidest.) are summarized as follows: Control 0/5; Test group 0/10 with positive reactions. (reading at 24 h and/or 48 h after the removal of the patch) Based on the results of this study it was concluded that 1-Butanaminium, N,N-dibutyl-N-methyl-, methyl sulfate does not have a sensitizing effect on the skin of the guinea pig in the Maximization Test under the test conditions chosen (BASF, 1998).
This study is the only avaiable information, but reliable and good documented and therefore integrated as key study.
Assessment:
As there were no positive reaction in a Magnusson Kligman test the substance is not rated as skin sensitizing.
Migrated from Short description of key information:
Skin sensitization: Guinea pig, similar to OECD 406, GLP: not skin sensitizing (BASF 1998)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the above information and according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, a classification of the substance as skin sensitizer is not justified.
Skinsensitizer:
-GHS: no classification
-DSD: no classification
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