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EC number: 463-070-5 | CAS number: 106966-25-0
- 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:
- 12.01. - 11.02.2005.
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- other: Skin Sensitisation
- Justification for non-LLNA method:
- According to EU Method B.6 (Skin Sensitisation)
Test material
- Reference substance name:
- -
- EC Number:
- 463-070-5
- EC Name:
- -
- Cas Number:
- 106966-25-0
- Molecular formula:
- C7H17N2O2Br
- IUPAC Name:
- 2-(3-methoxy-3-oxopropyl)-1,1,1-trimethylhydrazinium bromide
Constituent 1
In vivo test system
Test animals
- Species:
- other: Albino guinea pig
- Sex:
- male/female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
intradermal induction: 0.1% test substance in water for injection
topical induction: 10% test substance in vaseline
Concentration of test material and vehicle used for each challenge:
chalenge- topical application: 0.5% test substance in vaseli ne
Challengeopen allclose all
- Route:
- intradermal
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
intradermal induction: 0.1% test substance in water for injection
topical induction: 10% test substance in vaseline
Concentration of test material and vehicle used for each challenge:
chalenge- topical application: 0.5% test substance in vaseli ne
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- %
- 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: %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- other: No information about positive control group.
- Group:
- positive control
- Remarks on result:
- not measured/tested
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 1 %
The evaluation of skin reactions of exposed group showed the
erythema and oedema the subsided time 48 hours.
The evaluation of skin reactions in control group showed
only the marked sites of intradermal injections.
Topical application:
The evaluation of skin reations of exposed group showed in
all animals the discrete confluent erythema without oedema
in the test area with fade-out time 48 hours. The evaluation
of skin reactions in control group with vaseline did not
show any changes in skin of all animals.
Evidence of sensitisation of each challenge concentration:
The exposed animals in main study showed no allergic skin
reactions and no other negative clinical symptoms throughout
the experiment.
Other observations:
In pilot test concentration 20%, 10% and 5% of test
substance in water for injection by intradermal injections
caused death of all three animals. Vehement serous
discharges out of eyes, hard breathing and decelerated
motion were observed in other 2 animals immediatelly after
application of 1% and 0.5% test substance. Slight hydrous
discharge out of eyes only was observed after application of
0.1% test substance. All alterations faded away within 1
hour after application.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- The exposed animals in main study showed no allergic skin reactions and no other negative clinical symptoms throughout the experiment with guinea pig.
Alterations after application of the test substance were observed in animals in pilot study. Application 20%, 10% and 5% test substance in water for injection by intradermal injections caused death of all 3 females. Animals died within 5 minutes after application. Concentration of the test substance was reduced and applied to other three animals. Vehement serous discharges out of eyes, hard breathing (gasping) and decelerated motion were observed in 2 males immediately after application 1% and 0.5% test substance. Slight hydrous discharge out of eyes only, was observed in male after application 0.1% test substance. All alterations faded away within 1 hour after application.
The body weight of animals increased throughout the study and it was not affected by the treatment. In the course of experiment the animals did not show any clinical symptoms of intoxication.
The test substance was not shown to be a contact allergen in guinea pig.
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