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EC number: 213-156-1 | CAS number: 927-62-8
- 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
Respiratory irritation is expected. The reason is the strong irritating/corrosive effect of this substance and related primary, secondary and tertiary aliphatic amines with a similar pKa value.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Method: other: 40 CFR, Parts 160 and 792
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Mohican Valley Rabbitry, Loudonville, Ohio
- Animal weight at initiation: 2.7 - 3.8 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): animal room; controlled at 65-78°F
- Humidity (%): animal room; controlled at 35-70%
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- undiluted
TEST MATERIAL
- Amount applied: 0.5 mL per test side - Duration of treatment / exposure:
- - 3 minutes
- and 1 hour - Observation period:
- 7 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: no data
- Type of wrap if used: occlusive
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with distilled water
- Time after start of exposure: 3 minutes and 1 hour
SCORING SYSTEM: table contained in OECD 405 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 3 minutes
- Score:
- 4
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: necrosis at all treated sites
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hr
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: necrosis, eschar formation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hr
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: necrosis and eschar
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hr
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: eschar at al treated sites
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: day 7
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: eschar, exfoliation at all treated sites
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 3 minutes
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hr
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hr
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48 hr
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 hr
- Score:
- 1.33
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Interpretation of results:
- Category 1A (corrosive)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- N,N-dimethyl-n-butylamine produced skin corrosion at the three minute and 1-h exposure sites.
- Executive summary:
Skin irritation and corrosion was tested in a study that was conducted similar to OECD 405 and under GLP conditions. 0.5 mL of DMBA was applied to two clipped skin sites on each of three Newzealand White rabbits. One site was covered for 3 minutes, while the second site covered (occlusive) for one hour. Following each exposure, the test sites were wiped and immediately graded for dermal reactions. Further readings were made at 1, 24, 48, 72 hours and 7 days post treatment. The findings were scored according the table contained in OECD 405.
N,N-dimethyl-n-butylamine produced high-grade erythema (score 4) and necrosis at one hour postdose at the three minute and 1-h exposure sites. The dermal responses progressed to eschar at all sites by 24 hours and persisted to test termination on study day 7.
Very slight to moderate swelling (score 1 - 2) was observed at exposure sites during the first 24 hours postdose. This diminished by test termination. Due to the severe effects no further animals were used.
Under the conditions of this test, N,N-dimethyl-n-butylamine produced skin corrosion at the three minute and one hour exposure sites (Siglin, 1989).The study is considered to be valid and suitable for assessment.
Reference
Skin irritation and corrosion was tested in a study that was conducted similar to OECD 405 and under GLP conditions. 0.5 mL of DMBA was applied to two clipped skin sites on each of three Newzealand White rabbits. One site was covered for 3 minutes, while the second site covered (occlusive) for one hour. Following each exposure, the test sites were wiped and immediately graded for dermal reactions. Further readings were made at 1, 24, 48, 72 hours and 7 days post treatment. The findings were scored according the table contained in OECD 405.
N,N-dimethyl-n-butylamine produced high-grade erythema (score 4) and necrosis at one hour postdose at the three minute and 1-h exposure sites. The dermal responses progressed to eschar at all sites by 24 hours and persisted to test termination on study day 7. Very slight to moderate swelling (score 1 - 2) was observed at exposure sites during the first 24 hours postdose. This diminished by test termination. Due to the severe effects no further animals were used. Thus, under the conditions of this test, N,N-dimethyl-n-butylamine produced skin corrosion at the three minute and one hour exposure sites (Siglin, 1989).
The study is considered to be valid and suitable for assessment.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline studies with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 3.36 +/- 0.41 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Animals were held in isolated animal rooms with filtered air suply, temperature and humidity control
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- Group 1: 24 hrs
Group 2: 15 seconds - Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- Group 1: 6 animals; 24 hrs
Group 2: 3 animals; 15 seconds - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: Group 2
- Time after start of exposure: 15 seconds
SCORING SYSTEM: Draize (1959); table contained in OECD 405
TOOL USED TO ASSESS SCORE: biomicroscope - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: day 13
- Score:
- 13.3
- Max. score:
- 80
- Reversibility:
- not fully reversible within: 13 days
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 13 days
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- other: iris was not affected at any reading
- Remarks on result:
- other: unwashed eyes
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 13 days
- Score:
- 7.3
- Max. score:
- 20
- Reversibility:
- other: redness persisted (score: 1) on day 13 whereas chemosis and discharge were fully reversible. Corneal opacity was not reversible.
- Remarks on result:
- other: unwashed eyes
- Executive summary:
N,N-dimethylbutylamine was considered to be a severe eye irritant, based on the results of a study that was conducted essentially similar to OECD 405. The eye reactions of rabbits were recorded up to 14 days after the application of 0.1 mL of the test substance into the conjunctival sac of rabbits, either for 24 hours (Group 1, 6 animals) or 15 seconds (Group 2, 3 animals; eye washed with water). The eye reactions of Group 1 animals indicated marked reactions of the cornea and conjunctivae, whereas the iris was not affected. The conjunctival reactions were largely reversible by day 13, whereas the corneal lesions persisted until the end of the observation period. (Cox and Botta, 1979).
The study is considered to be valid with minor restrictions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
Skin irritation and corrosion was tested in a study that was conducted similar to OECD 405 and under GLP conditions. 0.5 mL of DMBA was applied to two clipped skin sites on each of three Newzealand White rabbits. One site was covered for 3 minutes, while the second site covered (occlusive) for one hour. Following each exposure, the test sites were wiped and immediately graded for dermal reactions. Further readings were made at 1, 24, 48, 72 hours and 7 days post treatment. The findings were scored according the table contained in OECD 405.
N,N-dimethyl-n-butylamine produced high-grade erythema (score 4) and necrosis at one hour postdose at the three minute and 1-h exposure sites. The dermal responses progressed to eschar at all sites by 24 hours and persisted to test termination on study day 7. Very slight to moderate swelling (score 1 - 2) was observed at exposure sites during the first 24 hours postdose. This diminished by test termination. Due to the severe effects no further animals were used. Under the conditions of this test, N,N-dimethyl-n-butylamine produced skin corrosion at the three minute and one hour exposure sites (Siglin, 1989). The study is considered to be valid and suitable for assessment.
Eye irirtation/corrosion
N,N-dimethylbutylamine was considered to be a severe eye irritant, based on the results of a study that was conducted essentially similar to OECD 405. The eye reactions of rabbits were recorded up to 14 days after the application of 0.1 mL of the test substance into the conjunctival sac of rabbits, either for 24 hours (Group 1, 6 animals) or 15 seconds (Group 2, 3 animals; eye washed with water). The eye reactions of Group 1 animals indicated marked reactions of the cornea and conjunctivae, whereas the iris was not affected. The conjunctival reactions were largely reversible by day 13, whereas the corneal lesions persisted until the end of the observation period. (Cox and Botta, 1979). The study is considered to be valid with minor restrictions.
Justification for selection of skin irritation / corrosion endpoint:
Skin corrosion could have been predicted from the pKa value of the free base, and no testing would have been required. The prediction is in line with an existing valid in-vivo study which was selected because it demonstrated corrosion within 3 minutes.
Justification for selection of eye irritation endpoint:
The existing in-vivo study was selected. The same effct level could have been predicted from teh pKa value of the free base.
Effects on skin irritation/corrosion: highly corrosive
Effects on eye irritation: corrosive
Effects on respiratory irritation: irritating
Justification for classification or non-classification
Proposed classification: Cat 1A
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