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EC number: 203-699-2 | CAS number: 109-73-9
- 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
n-Butylamine is corrosive to skin (Category 1A) and causes sever damage to the eyes (Category 1). Further, respiratory irritation was observed after inhalation exposure.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 1 min exposure instead of 4 h, combined with various post-exposure procedures of effect mitigation
- Principles of method if other than guideline:
- Method: Objective was to examine three first-aid measures to prevent/mitigate corrosion
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult
- Weight at study initiation: 2.0 - 3.5 kg
- Housing:
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 21 (61 - 70 °F)
- Humidity (%): 40 - 60
- Photoperiod (hrs dark / hrs light): 12 / 12
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Dose 0.5 ml
- Duration of treatment / exposure:
- 1 minute
- Observation period:
- 1, 24, 72 h, 7 and 14 d post-application ( 14 d added, according to Protocol Amendment No. 1 of 02 March 1993)
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: approx. 1 square inch
- % coverage: no data
- Type of wrap if used: gauze patch (8-ply)
REMOVAL OF TEST SUBSTANCE
Group 1 (no particular preventive measure)
Washing (if done): no, wiping with dray gauze
- Time after start of exposure: 1 min
Group 2 (rinsing)
Washing (if done): yes, 5 min distilled water (about 2 L per animal)
- Time after start of exposure: 1 min
Group 3
Washing (if done): yes, 1 min 5% (v/v) reagent-grade acetic acid/distilled water (about 0.5 L per animal)
- Time after start of exposure: 1 min
Group 4 (according to Protocol Amendment No. 1 of 02 March 1993)
Washing (if done): yes, 0.5 min distilled water (about 0.25 L per animal), 1 min PEG300 swabbing (gentle wiping) of each test site
(gauze moistend in PG300) and 3.5 min distilled water rinse (about 1.75 L per animal)
- Time after start of exposure: 1 min
SCORING SYSTEM: Draize numerical scoring system for quantitive grading of erythema and edema - Irritation parameter:
- erythema score
- Remarks:
- (no washing, Group 1)
- Basis:
- animal #1
- Time point:
- other: 1 hour - 14 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: immediate necrosis followed by eschar formation
- Irritation parameter:
- erythema score
- Remarks:
- (no washing, Group 1)
- Basis:
- animal #2
- Time point:
- other: 1 hour - 14 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: immediate necrosis followed by eschar formation
- Irritation parameter:
- erythema score
- Remarks:
- (no washing, Group 1)
- Basis:
- animal #3
- Time point:
- other: 1 hour - 14 d
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: immediate necrosis followed by eschar formation
- Irritation parameter:
- erythema score
- Remarks:
- Group 1
- Basis:
- mean
- Remarks:
- mean value for animal #1, #2, and #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other:
- Remarks:
- Maximum score of 4 at 24 h and 72 h.
- Irritation parameter:
- edema score
- Remarks:
- no washing, Group 1
- Basis:
- mean
- Remarks:
- mean value for animal #1, #2, and #3
- Time point:
- 24 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- no washing, Group 1
- Basis:
- mean
- Remarks:
- mean value for animal #1, #2, and #3
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Remarks:
- no washing, Group 1
- Basis:
- mean
- Remarks:
- mean value for animal #1, #2, and #3
- Time point:
- 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Not any of the washing measures taken could prevent the corrosive activity of n-butylamine.
- Interpretation of results:
- Category 1A (corrosive) based on GHS criteria
- Conclusions:
- Under the conditions of this test skin corrosive effects were already detectable after 1 min of exposure.
- Executive summary:
In this dermal irritation study, 3 New Zealand White rabbits were exposed semiocclusively to 0.5 ml of the undiluted test substance on 1 square inch for 1 min. The test substance was removed by a) wiping with dray gauze; b) washing for 5 min distilled water (about 2 L per animal) or c) 1 min 5% (v/v) reagent-grade acetic acid/distilled water (about 0.5 L per animal).
Examinations of irritation/corrosion were performed 1, 24, 72 h and 7 and 14 d post-application. The effects were scored according to the Draize numerical scoring system for quantitive grading of erythema and edema. The exposure without washing produced immediate necrosis followed by eschar formation. The washing measures abated the corrosive activity of the test substance. The erythema score (without washing) was 4.0, the edema score was 2.3, and the effects were not fully reversible within 14 days. Under the conditions of this test skin the test substance was corrosive.
Reference
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- BASF-Test, see details in remarks on material and methods.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the adjacent eye served as control treated with 0.9 % NaCl (saline).
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 50 µl - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 5 weeks
- Number of animals or in vitro replicates:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: effects not evaluable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no effects
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The test substance induced irreversible effects on the eye.
- Executive summary:
An eye irritation test was performed in two Vienna White rabbits. 50 μl of the test substance were applied to the conjunctival sac of one eye in 2 animals. The eyes were not washed out after 24 hours. The animals were observed after 10 min, 1 h and 3 h on the day of treatment and up to 5 weeks afterwards. The application of the test substance caused after 10 minutes slight chemosis, necrosis and corneal opacity. Therefor a precise evaluation of erythema and iritis scores was not possible. The effects were not reversible within 5 weeks in animal 1.
The mean scores of eye irritation (24, 48 and 72 h) were for both animals: Opacity: 3; Iritis: not possible to examine; Erythema: 0; Chemosis: 1. The test substance induced irreversible effects on the eye.
Reference
Findings: animal1/animal2
Time | Corneal opacity | Iritis | Erythema | Chemosis | |||
1 h | 3/3 | -/- | 0/0 | 1/1 | |||
24 h | 3/3 | -/- | 0/0 | 1/1 | |||
48 h | 3/3 | -/- | 0/0 | 1/1 | |||
72 h | 3/3 | -/- | 0/0 | 1/1 | |||
8 days | 3/x | -/x | 0/x | -/x |
x: animal 2 was sacrificied after 5 days due to paraplegia.
-: due to corneal opacity not evaluable
The original BASF grading was converted into the numerical grading according the OECD Draize system.
Mean values over 24 h, 48 h and 72 h:.
Animal1: Opacity: 3; Iritis: -; Erythema: 0; Chemosis: 1;
Animal2: Opacity: 3; Iritis: -; Erythema: 0; Chemosis: 1;
The application of the test substance caused after 10 minutes slight chemosis, necrosis and corneal opacity. Therefor a precise evaluation of erythema and iritis scores was not possible. The effects were not reversible within 5 weeks (animal1). Severe corneal opacity is considered to be an irreversible effect to ophthalmic tissue.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Local effects on skin, eye and respiratory tract were observed in several in vivo studies, which revealed that the test item is corrosive to skin already after 1 min of application (Cat. 1A) and causes severe eye damage. Local effects were also observed in the respiratory tract after acute and repeated inhalation.
Additionally, spontaneous reflectory suppression of the respiration rate, 50 % of normal, caused by sensory irritation in the upper airways (interaction with nerve endings) was observed at exposure concentrations (RD50 values) as low as 260 - 370 mg/m3 (~80 - 120 mL/m3) in mice (Gagnaire et al. 1989/1993; Nielsen et al. 1988). A kind of NOAEC, RD0 value, for inhibition of the respiration rate was found at 36 mg/m3 (12 mL/m3) (Nielsen et al. 1988).
These in vivo findings are in accordance with the observeation that the aqueous solution of the test item (50%) has an extreme pH-value of 13, already indicating the corrosive properties of the substance.
Justification for classification or non-classification
Based on the experimental studies and the extreme pH value of the aqueous solution of the substance a classification as skin corrosive (Cat. 1A), causing severe eye damage and respiratory irritation (STOT SE Cat. 3) is recommended according to Regulation (EC) No. 1272/2008.
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