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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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because a pre-natal developmental toxicity study is available
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Version / remarks:
- - for inhalation exposure considering OECD - Guideline method 412
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Boehringer Ingelheim Pharma KG, Biberach an der Riss, Germany
- Age at study initiation: about 9-10 weeks
- Weight at study initiation:
- Housing: singly in DK 111 stainless steel wire mesh cages
- Diet: rat/mouse/hamster laboratory diet, 10 mm pellets (Provimi Kliba SA, Kaiseraugst, Switzerland), ad libitum.
- Water: tap water ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass-steel inhalation chamber, volume of 1.4 m3 (BASF AG)
- Method of holding animals in test chamber: whole body exposure
- Temperature, humidity, in air chamber: 21.2 - 22.5 %; 50.5 - 62.0 %
- Air change rate: ca. 20 x h
TEST ATMOSPHERE
- Brief description of analytical method used: GC/FID after absorption in DMF
- Samples taken from breathing zone: yes
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Gas chromatograph equipped with autosampler, split injector and flame ionization detector (FID) and adapted to a chromatography data system
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1-3
- Length of cohabitation: 4.00 pm - 7.30 am (15.5 h)
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- days 6-19 p.c.
- Frequency of treatment:
- 6 h/day
- Duration of test:
- 20 days
- Remarks:
- Doses / Concentrations:
51.4 +-2.2; 151.8 +-9.2; and 460 +-17.5 mg/m3 [= 17, 50.1, and 151.8 mL/m3]
Basis:
analytical conc. - No. of animals per sex per dose:
- 25 (Implantation sites were present in 20, 23, 24 and 23 animals of test groups 0, 1, 2 and 3, respectively).
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: pretest
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice a day
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: at least 3 times on exposure days and, as a rule, once during the day 0, preflow period and post-exposure observation day.
BODY WEIGHT: Yes
- Time schedule for examinations: day 0, 1, 3, 6, 8, 10, 13, 15,17, 19 and 20 p.c..
POST-MORTEM EXAMINATIONS: Yes, gross pathology
- Sacrifice on gestation day # 20
OTHER: Histopathology of head with larynx - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: all per litter - Statistics:
- The Dunnett-test was used for a simultaneous comparison of several dose groups with the control. Fisher's Exact test was used for pairwise comparisons. The WILCOXIN test was used for a comparison of each dose with the control for the hypothesis of equal medians.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- gravid uterine weights were unaffected by exposure
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Only local effects in the upper respiratory tract due to irritation, details see below
No gross effects were observed in the uterus. Further other organs were not examined - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Only local effects in the upper respiratory tract due to irritation, details see below
- Histopathological findings: neoplastic:
- not examined
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not specified - Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Treatment-related findings were confined to the anterior section (level 1) of the nasal cavity. Minimal to slight focal necrosis of the nasal mucosa was seen in five, necrosis of the underlying nasal bone in one female of the high concentration group. Necrosis was predominantly located at the nasoturbinates, thus affecting transitional epithelium. (Multi)focal squamous cell metaplasia and purulent to mixed inflammatory cell infiltration were found in all treatment groups in the anterior part of the nose (level 1). The predominant location were the turbinates and the lateral wall. Focal hyperplasia of the transitional epithelium was observed in 6 animals of the mid and one animal of the low concentration group. Predilection sites were the nasal turbinates and the lateral wall. Incidence and severity decreased from top concentration to low concentration group for all treatment-related findings. - Key result
- Dose descriptor:
- LOAEC
- Effect level:
- 51 mg/m³ air (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 460 mg/m³ air (analytical)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Key result
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: local irritation in the upper respiratory tract
- Description (incidence and severity):
- Effects were observed at all exposure concentrations
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 460 mg/m³ air (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: developmental toxicity, highest dose tested
- Key result
- Abnormalities:
- not specified
- Key result
- Developmental effects observed:
- not specified
- Conclusions:
- Under the conditions of this study, local effects were observed in the nose of dams. No effects on gestational parameters and offspring were evident.
- Executive summary:
Twenty-five mated female Wistar rats per test group were whole-body exposed to dynamic atmospheres of Mono-n-Butylamin vapors for 6 hours per day on day 6 through day 19 post coitum (p.c.; 14 exposures). The target concentrations were 50, 150 and 450 mg/m 3. A concurrent control group was exposed to clean air.
No treatment related clinical findings were observed. A concentration dependent increase in incidence and severity of changes in the epithelium of the anterior nasal cavity (necrosis, hyper- and metaplasia, inflammatory cell infiltration) occurred. Under the conditions of this prenatal developmental toxicity study, the inhalation exposure of pregnant Wistar rats to vapours of Mono-n-Butylamin from implantation to one day prior to the expected day of parturition (days 6 - 19 p.c.) elicited maternal toxicity at all tested concentrations. Maternal toxicity was substantiated by changes of the respiratory epithelium in the nasal cavity.
There were no substance-induced, concentration-related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance-induced indications of teratogenicity, up to and including the highest concentration (450 mg/m 3).
Mono-n-butylamine elicited maternal toxicity at all tested concentrations. Maternal toxicity was substantiated by changes of the respiratory epithelium in the nasal cavity.
There were no substance-induced, concentration-related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substance induced indications of teratogenicity, up to the highest concentration.
Based an these results, the no observed adverse effect concentration (NOAEC) for prenatal developmental toxicity is 0.45 mg/L air (152 mL/m3).
Summary of maternal and fetal data after inhalation exposure to n-butylamine (from Gamer et al. 2002, Tab. 3)
Inhalation concentration [ppm] |
0 |
17 |
50 |
152 |
Females mated |
25 |
25 |
25 |
25 |
Number of maternal deaths, abortions, premature births and total resorptions |
0 |
0 |
0 |
0 |
Females pregnant at scheduled necropsy |
20 |
23 |
24 |
23 |
Mean gravid uterus weight (g) |
78.4±13.0 |
82.5±12.5 |
82.7±11.6 |
80.8±13.9 |
Mean net maternal body weight gain from day 6 post coitum (g) |
42.5±8.6 |
46.3±10.9 |
47.6±9.6 |
40.4±9.8 |
Mean corpora lutea |
15.9±1.9 |
16.8±2.4 |
16.8±1.4 |
16.4±1.6 |
Mean implantation sites |
15.1±2.8 |
15.7±2.2 |
16.3±1.9 |
15.4±2.4 |
Mean % pre-implantation loss |
5.8 |
6.9 |
3.4 |
5.8 |
Mean % post-implantation loss |
6.4 |
6.5 |
10.9 |
7.9 |
Mean % early resorptions |
6.4 |
6.5 |
10.1 |
7.1 |
Mean % late resorptions |
0.0 |
1.2 |
0.8 |
0.8 |
Mean number of live fetuses per litter |
14.1±2.6 |
14.4±2.3 |
14.5±2.2 |
14.2±2.5 |
Number of dead fetuses |
0 |
0 |
0 |
0 |
Mean placenta weight (g) |
0.45±0.04 |
0.46±0.04 |
0.46±0.06 |
0.47±0.05 |
Mean fetal weight (g) |
3.7±0.2 |
3.8±0.3 |
3.8±0.2 |
3.8±0.2 |
Percentage of litters with any malformation |
5 |
13 |
17 |
17 |
Mean % of fetuses/litter with any malformation |
0.4 |
1.2 |
1.1 |
1.2 |
Group means±standard deviation
Fetal and litter incidence of external, soft tissue and skeletal malformations after inhalation exposure
to n-butylamine (from Gamer et al. 2002, Tab. 4)
Inhalation concentration [ppm] |
0 |
17 |
50 |
152 |
Number of litters with live fetuses |
20 |
23 |
24 |
23 |
Total number of fetuses examined (soft tissue/skeletal examination) |
282 (134/148) |
332 (159/173) |
348 (169/179) |
327 (158/169) |
Number (%) of litters with external malformation |
0 (0 %) |
0 (0 %) |
1 (4 %) |
0 (0 %) |
Number of fetuses (mean % fetuses/litter) with external malformation |
0 (0 %) |
0 (0 %) |
1(0.3 %) |
0 (0 %) |
Number (%) of litters with soft tissue malformation |
0 (0 %) |
1 (4 %) |
1 (4 %) |
0 (0 %) |
Number of fetuses (mean % fetuses/litter) with soft tissue malformation |
0 (0 %) |
1 (0.5 %) |
1 (0.5 %) |
0 (0 %) |
Number (%) of litters with skeletal malformation |
1 (5 %) |
2 (9 %) |
3 (13 %) |
4 (17 %) |
Number of fetuses (mean % fetuses/litter) with skeletal malformation |
1 (1 %) |
3 (2 %) |
3 (2 %) |
4 (2 %) |
Number (%) of litters with any malformation |
1 (5 %) |
3 (13 %) |
4 (17 %) |
4 (17 %) |
Number of fetuses (mean % fetuses/litter) with any malformation |
1 (0.4 %) |
4 (1 %) |
4 (1 %) |
4 (1 %) |
Group means±standard deviation
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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