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EC number: 237-732-7 | CAS number: 13952-84-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 1980
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
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:
- other: guinea pig using the maxixmisation method
- Justification for non-LLNA method:
- LLNA was not implemented in 1980
Test material
- Reference substance name:
- sec-butylamine
- EC Number:
- 237-732-7
- EC Name:
- sec-butylamine
- Cas Number:
- 13952-84-6
- Molecular formula:
- C4H11N
- IUPAC Name:
- butan-2-amine
Constituent 1
- Specific details on test material used for the study:
- Liquid product, 2 - aminobutan, supplied
by Ruhrchemie Aktiengesellschaft.
For the purpose of the test the f_ollowing
concentrations of the test material were
prepared as required in water for injection
B.P.
Intradermal Induction 1%
Topical Induction 40%
Topical Challenge 10%
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Twenty, female, albino Dunkin-Hartley *
guinea pigs in the weight range 350 - 450·g
were used. Animals were housed in groups of
five (test) or four (control) in suspended
metal cages, and given water and food (Guinea
Pig Diet, J. Waring (Feeds) Limited, Shardlow,
Derbyshire), ad libitum. The diet was
supplemented with a daily ration of hay
toge1;her with vitamin C tablets '(Redoxon 200_,
Roche Products Limited) disso.lved in the
drinking water.
The temperature of the animal room was
.controlled at 19 ~ 3°c and the lighting cycle
was 14 hours on, 10 hours off with no daylight.
Animals were individually identified by_an
indelible number marked on the outer surfac·e.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- Intradermal 1%
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 40%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 10%
- Day(s)/duration:
- 24h, 48h
- No. of animals per dose:
- Twenty, female, albino Dunkin-Hartley *
pre-test: Animals were housed in groups of
five (test) or four (control)
Main test: 10 animals per test group and 4 control animals. - Details on study design:
- preliminary testing:
1- intraderma / 24h, 48h, 72h, 7 days: 1%
2-intradermal 24h, 48h, 72h, 7 days: 5%
Topical route: 0, 24h, 48h : 5%, 10%, 20%, 40% - Challenge controls:
- A group of four previously intreated (non induced) guinea pigs were treated exactly as the test group at the challenge stage only.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% for challenge
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
see document with summarizing attached below
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The test material was examined for possible contact sensitization potential in the guinea pig using the maximization method described by Magnusson and Kligman. J. Invest. Derm. 1969, 52, 268 - 276.
The study consisted of a two stage induction procedure on each of a group of ten guinea pigs ,· followed by topical challenge two week's later. A further group of four untreated - contrpl (noninduced) guinea pigs received identical treatment as
the test group at the challenge stage only, The number of test animals that showed significantly more reaction at the test sites than the
most severe reaction seen at the test sites in the untreated control animals, were presumed to have exhibited a positive reaction.
The test material, 2 - aminobutane, produced a 0% sensitization rate and was classified as a weak contact sensitizer.
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