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EC number: 222-179-6 | CAS number: 3378-72-1
- 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:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study using concurrent standards of quality assurance standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- precedes establishement of LLNA
Test material
- Reference substance name:
- N-(tert-butyl)benzylamine
- EC Number:
- 222-179-6
- EC Name:
- N-(tert-butyl)benzylamine
- Cas Number:
- 3378-72-1
- Molecular formula:
- C11H17N
- IUPAC Name:
- N-(tert-butyl)benzylamine
- Test material form:
- liquid
- Details on test material:
- Distilled NBTB, N-Benzyl-tert-butylamine; N-(1,1-dimethylethyl) benzene-methanamine. Purity 99.3% (average). Liquid. Store at room temperature.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- The animals were housed in suspended cages with wire mesh floors.
They had free access to tap water and a Vitamin C rich Guinea Pig diet. Hay was given once weekly.
Room Temperature: 21 deg C.
Humidity: 30-70%
15 air changes per hour
12 hours of artificial light in every 24 hour period.
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- 1% (v/v) intradermal, with Freund's Complete Adjuvant
20% (v/v) topical - Day(s)/duration:
- 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: liquid paraffin
- Concentration / amount:
- 10% and 5%
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 animals were used for induction
10 animals were used as control - Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 7 days after intradermal injection with FCA
- Test groups: 20 animals
- Control group: 10 animals
- Site: Dorsal skin of scapula
- Frequency of applications: intradermal, 1 topical
- Duration: Topical exposure was 48 hr in duration
- Concentrations: 1% (v/v) intradermal; 20% (v/v) topical
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (2 doses, one on right flank, one on left flank)
- Day(s) of challenge: 14 days after topical exposure
- Exposure period: 24 h
- Test groups:
- Control group: same but without test material
- Site: right and left flanks
- Concentrations: 10% and 5%
- Evaluation (hr after challenge): 24, 48 and 72 hr after removal of patch
A 4 x 6 cm area of dorsal skin on the scapular region of the guinea-pig was clipped free of hair with electric clippers. Three pairs of intradermal injections were made simultaneously into this area as discussed below:
1. Freund's complete adjuvant was diluted with anequal volume of water for irrigation.
2. N-Benzyl-tert-butylamine, 1% v/v in liquid paraffin.
3. N-Benzyl-tert-butylamine, 1% v/v in a 50/50 mixture of Freund’s complete adjuvant and liquid paraffin.
Topical application:
One week after the injections, the same 4 x 6 cm interscapular area was clipped and shaved free of hair. A 2 x 4 cm patch of Whatman No. 3 paper was saturated with N-benzyl-tert-butylamine, 20% v/v in liquid paraffin. The patch was placed on the skin and covered by a length of impermeable plastic adhesive tape {5 cm width “Blenderm”). This in turn was firmly secured by elastic adhesive bandage ("Elastoplast" 5 cm width) wound around the torso of the animal and fixed with “Sleek” impervious plastic adhesive tape. The dressing was left in place for 48 hours.
Control animals:
During the induction period the control animals were treated similarly to the test animals with the exception that the test compound was omitted from the intradermal injections and topical application.
Challenge:
The test and control animals were challenged topically two weeks after the induction period using N-benzyl-tertbutylamine, 10% and 5% v/v in liquid paraffin.
Hair was removed by clipping and then shaving from an area on the left flank of each guinea-pig. A 2x2 cm patch of Whatman No. 3 paper was saturated with approximately 0.2 ml of N-benzyl-tert-butylamine, 10% v/v in liquid paraffin and applied to an anterior site on the flank. N-Benzyl-tert-butylamine, 5% v/v in liquid paraffin was applied in a similar manner a posterior site. The patches were sealed to the flank for 24 hours under strips of “Blenderm” covered by “E lastoplast" wound around the trunk and secured with “Sleek".
Reading the challenge reactions:
The challenge sites were evaluated 24, 48 and 72 hours after removal of the patches. The numerical scores awarded to dermal reactions resulting from the challenge application were recorded. - Challenge controls:
- without test material
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- Dermal reaction "more marked", definitive positive
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
N-Benzyl-Tert-Butylamine produced evidence of delayed contact hypersensitivity in two animals. There was no evidence of delayed contact hypersensitivity seen in eighteen animals. The test substance is evaluated as not sensitising.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a maximization protocol in guinea pigs, the test substance was determined not to be sensitising. The criteria for classification for the sensitisation endpoint is not met.
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