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EC number: 203-851-8 | CAS number: 111-26-2
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 19 Jan 1994 - 14 Feb 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study Please refer to section 13 (read across statement).
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 002
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Butylammonium chloride
- EC Number:
- 223-369-1
- EC Name:
- Butylammonium chloride
- Cas Number:
- 3858-78-4
- IUPAC Name:
- butan-1-aminium chloride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: DR. K. THOMAE GmbH, Biberach an der Riss, Germany
- Age at study initiation: 75 - 82 days
- Weight at study initiation: 237 g (mean)
- Housing: singly in type DK III stainless steel wire mesh cages
- Diet: Kliba 343 feed rat/mouse/hamster (KLINGENTALMUHLE AG, Kaiseraugst, Switzerland) ad libitum
- Water: water ad libitum
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- double distilled water
- Justification for use and choice of vehicle (if other than water): TS is water soluble
- Concentration in vehicle: 64.9 %
- Amount of vehicle (if gavage): 34.5 % - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Stability and purity verified by potentiometric titration
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1-3
- Length of cohabitation: 15.5 h
- Verification of same strain and source of both sexes: yes
- Proof of pregnancy: sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 6-15 d p.c.
- Frequency of treatment:
- 1x/d
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 400, and 1000 mg/(kg*d) (in 10 ml dissolved in water)
Basis:
nominal in water
These salt doses are equivalent to approx. 66, 265, and 660 mg amine base/(kg*d) (66 % of the HCl salt).
- No. of animals per sex per dose:
- 22-24 pregnant females per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
The TS concentration was based on observations made from a range finding study with pregnant rats
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: 1x/d
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: 1x/d
BODY WEIGHT: Yes
- Time schedule for examinations: on days 0, 1, 3, 6, 8, 10, 13, 15, 17 and 20 p.c.
Corrected body weight gain was calculated after the terminal sacrifice (terminal body weight on d 20 p.c. minus weight of unopened uterus minus body weight on d 6 p.c.).
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes / on days 0, 1, 3, 6, 8, 10, 13, 15, 17 and 20 p.c.
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: uterus, ovary, placenta
The weight of the unopened uterus, the number of corpora lutea, the number and distribution of implantations, as well as live fetuses and dead implantations were determined.
The weight and sex ratio of fetuses was also determined. Further determinations were made of fetuses by macroscopic examinations, soft tissue examinations were made after fixation in BOUIN's solution (approx. half of the fetuses) and skeletal examinations were made on half of the fetuses after fixation in alcohol and staining according to the method of DAWSON (Stain Technol. 1, 123, 1926).
- 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: No data - 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 WILCOXON test was used for a comparison of each dose with the control for the hypothesis of equal medians.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
At 1000 mg/kg bw:
- A statistically significant reduction in food consumption during days 6-13 p.c. (ca. 8% lower than the corresponding control).
- A statistically significant impairment of body weight gain (14% less than controls if calculated for the total treatment period).
- A statistically significant lower mean gravid uterus weight (ca. 13% lower than the control group).
- A statistically significant increased number of resorptions, increased post-implantation loss value,
and lower mean percentage of live fetuses
- A statistically significant decrease in the mean placental weight (20%).
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 400 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
At 400 mg/kg bw
- A statistically significant increase in the rate of fetuses with soft tissue malformations was seen. Namely, 3 fetuses from 3 different
litters showed the same or similar malformations of the heart, great vessel or the diaphragm as seen at the 1000 mg/kg bw .
At 1000 mg/kg bw::
- Lower mean percentage of live fetuses
- Decrease in fetal body weight (8%)
- Slight, but statistically significant increase in the rate of external, soft tissue and total malformations was observed.
This included the occurrence of two rare external malformations of the tail (filiformed or kinky tail) in 3 fetuses from 3 different litters
and several malformations of the heart, the great vessels and the diaphragm in 6 fetuses out of 4 litters.
- A statistically significant increased rate of fetuses with skeletal retardations (esp. incomplete ossification of the skull and sternebra(e)) was noted.
This last finding should be seen in relation to the lower mean fetal body weights.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Dose descriptor:
- LOAEL
- Effect level:
- 400 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Summary of maternal and fetal data after oral exposure to n-butylamine hydrochloride (from Gamer et al. 2002, Tab. 1)
Dose [mg/kg*day] |
0 |
100 |
400 |
1000 |
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 |
22 |
24 |
22 |
24 |
Mean gravid uterus weight (g) |
77.5 ±15.9 |
78.1 ±11.3 |
76.5 ±15.7 |
67.1 ±11.6* |
Mean net maternal body weight gain from day 6 post coitum (g) |
44.0 ±6.6 |
42.8 ±9.9 |
50.4 ±8.8 |
45.8 ±9.5 |
Mean corpora lutea |
16.3 ±2.2 |
16.9 ±1.9 |
16.0 ±2.4 |
15.9 ±2.1 |
Mean implantation sites |
14.3 ±2.6 |
15.4 ±2.2 |
15.0 ±2.2 |
14.3 ±2.6 |
Mean % pre-implantation loss |
12.1 |
8.8 |
6.3 |
9.8 |
Mean % post-implantation loss |
5.7 |
9.5 |
11.0 |
12.5* |
Mean % early resorptions |
4.3 |
6.4 |
8.2 |
10.0 |
Mean % late resorptions |
1.4 |
3.1 |
2.8 |
2.5 |
Mean number of live fetuses per litter |
13.5 ±2.8 |
13.9 ±2.2 |
13.4 ±2.9 |
12.5 ±2.5 |
Number of dead fetuses |
0 |
0 |
0 |
0 |
Mean placenta weight (g) |
0.44 ±0.04 |
0.43 ±0.04 |
0.41 ±0.03 |
0.35 ±0.04** |
Mean fetal weight (g) |
3.8 ±0.3 |
3.8 ±0.2 |
3.8 ±0.2 |
3.5 ±0.3** |
Percentage of litters with any malformation |
18 |
21 |
36 |
46* |
Mean % of fetuses/litter with any malformation |
2.5 |
1.6 |
3.8 |
6.2* |
group means +- S.D.
* P 0.05; ** P 0.01
Fetal and litter incidence of external, soft tissue and skeletal malformations after oral administration of n-butylamine hydrochloride (from Gamer et al. 2002, Tab. 2)
Dose [mg/kg*day] |
0 |
100 |
400 |
1000 |
Number of litters with live fetuses |
22 |
24 |
22 |
24 |
Total number of fetuses examined (soft tissue/skeletal examination) |
296 (144/152) |
333 (161/172) |
295 (143/152) |
300 (143/157) |
Number (%) of litters with external malformation |
0 (0 %) |
0 (0 %) |
0 (0 %) |
3 (13 %) |
Number of fetuses (mean % fetuses/litter) with external malformation |
0 (0 %) |
0 (0 %) |
0 (0 %) |
3 (1 %) |
Number (%) of litters with soft tissue malformation |
0 (0 %) |
0 (0 %) |
3 (14 %) |
4 (17 %) |
Number of fetuses (mean % fetuses/litter) with soft tissue malformation |
0 (0 %) |
0 (0 %) |
3 (3 %*) |
6 (4 %*) |
Number (%) of litters with skeletal malformation |
4 (18 %) |
5 (21 %) |
6 (27 %) |
7 (29 %) |
Number of fetuses (mean % fetuses/litter) with skeletal malformation |
7 (5 %) |
5 (3 %) |
7 (5 %) |
10 (6 %) |
Number (%) of litters with any malformation |
4 (18 %) |
5 (21 %) |
8 (36 %) |
11 (46 %*) |
Number of fetuses (mean % fetuses/litter) with any malformation |
7 (4 %) |
5 (2 %) |
10 (4 %) |
19 (6 %*) |
group means +- S.D.
*) P 0.05
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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