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EC number: 235-186-4 | CAS number: 12125-02-9
- 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
Oral:
In an acute oral toxicity study similar to OECD guideline 401 in rat, an LD50 of 1410 mg/kg bw was determined.
Dermal:
In an acute dermal toxicity study similar to EU method B.3 in rat, an LD50 of above 2000 mg/kg bw was determined.
Inhalation:
Not a relevant route of exposure.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (10 animals/sex/dose)
- Principles of method if other than guideline:
- The study was conducted according to an internal BASF method whose principle is comparable to the OECD Guideline 401. A test group consisting of 10 animals/sex/dose was treated by single gavage with an aqueous solution of the test substance. Body weights were monitored during the 14 day observation period. The animals were observed for mortality and for clinical signs of toxicity for a period of 14 days. Decedents were subjected to necropsy. At the end of the observation period, the surviving animals were sacrificed (CO2 aphyxiation) for the purpose of necropsy. The LD50 value was estimated on the basis of the observed mortalities using the method of Finney D. J (Probit analysis, Cambridge University Press, 3 Aufl., 1971).
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Physical state: solid
- Analytical purity: 99.7% - Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr.K.THOMAE GmbH, Biberach, Germany
- Weight at study initiation: male: 170-178 g, female: 171-187 g (within 20% of mean weight)
- Fasting period before study: The animals were given no feed for 16 hours before administration, but water was available ad libitum
- Housing: 5 animals per cage (Type VII A steel cages; FA Becker & Co., Castrop-Rauxel)
- Diet: Kliba-Labordiaet, (Klingentalmuehle AG, CH); ad libitum
- Water: tap water; ad libitum
- Acclimation period: for at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20- 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- - Concentration of test substance in vehicle: 6.81, 10, 14.7, 21.5 %
- Maximum Volume applied: 10 mL/kg bw - Doses:
- 681, 1000, 1470, 1780, 2150 mg/kg bw
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: several times on the day of administration, at least once each workday. Check for mortality and moribund animals was performed twice daily on week days and once daily on Saturday, Sunday or on public holidays.
- Frequency of weighing: days 0, 3, 4, 7, 9, 13
- Necropsy of survivors performed: yes; before sacrifice, animals were fasted for a period of 16 hours
- Other examinations performed: clinical signs, body weight, histopathology - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 410 mg/kg bw
- Based on:
- dissolved
- Remarks:
- in water
- 95% CL:
- >= 1 260 - <= 1 550
- Remarks on result:
- other: Slope factor = 1.36
- Mortality:
- Mortality: (out of 10 males and 10 females)
- Number of dead males at doses 2150, 1780, 1470, 1000 and 681: (after 1h) 8/7/4/0/0, (after 1d) 8/7/4/0/0, (≥2-14d) 8/7/4/0/0
- Number of dead females at doses, 2150, 1780, 1470, 1000, 681: (after 1h) 10/9/7/0/0, (after 1d) 10/9/7/3/0, (≥2-14d) 10/9/7/3/0 - Clinical signs:
- other: No clinical signs were manifested by animals of the lowest dose group (NOEL clinical signs = 681 mg/kg bw). Clinical signs were seen in animals dosed with 1000 mg/kg bw and above. Clinical symptoms indicated an influence on the central nervous system. Fo
- Gross pathology:
- Dying animals:
- General congestion: poor
- Heart: dilatation bilaterally; sporadically dilatation on the left side;
- Stomach: atonic; liquid contents; malacia of the mucosa in the glandular stomach;
- Intestines: atonic, diarrheal and mucous contents; malacia of the mucosa in several cases; - Other findings:
- Histopathology (only one animal):
- Liver: fatty degeneration
- Kidney: fatty degeneration, lower nephron nephrosis - Interpretation of results:
- Category 4 based on GHS criteria
Reference
Table 1: Mortality
Dose (mg/kg bw) |
Conc. |
Gender |
1 h |
24 h |
48 h |
day 7 |
day 14 |
2150 |
21.5 |
male |
8 |
8 |
8 |
8 |
8 |
female |
10 |
10 |
10 |
10 |
10 |
||
1780 |
17.8 |
male |
7 |
7 |
7 |
7 |
7 |
female |
9 |
9 |
9 |
9 |
9 |
||
1470 |
14.7
|
male |
4 |
4 |
4 |
4 |
4 |
female |
7 |
7 |
7 |
7 |
7 |
||
1000 |
10.0 |
male |
0 |
0 |
0 |
0 |
0 |
female |
0 |
3 |
3 |
3 |
3 |
||
681 |
6.81 |
male |
0 |
0 |
0 |
0 |
0 |
female |
0 |
0 |
0 |
0 |
0 |
Table 2: Weight (g)
Dose (mg/kg bw) |
Gender |
day 0 |
day 3/4 |
day 7 |
day 9 |
day 13 |
2150 |
male |
178 |
216 |
248 |
262 |
- |
female |
178 |
- |
- |
- |
- |
|
1780 |
male |
171 |
206 |
236 |
245 |
- |
female |
179 |
198 |
210 |
219 |
- |
|
1470 |
male |
170 |
210 |
241 |
251 |
- |
female |
179 |
204 |
220 |
221 |
- |
|
1000 |
male |
177 |
226 |
246 |
- |
283 |
female |
179 |
207 |
213 |
- |
226 |
|
681 |
male |
170 |
221 |
240 |
- |
269 |
female |
171 |
205 |
210 |
- |
218 |
Table 3: Clinical signs
Dose (mg/kg bw) |
2150 |
1780 |
1470 |
1000 |
681 |
|||||
|
male |
female |
male |
female |
male |
female |
male |
female |
male |
female |
Dyspnea |
<15 m-5 h |
<15 m-30 m |
<15 m-5 h |
<15 m-5 h |
<15 m-5 h |
<15 m-5 h |
15 m-2 h |
15 m-2 h |
- |
- |
Apathy |
<15 m-1 h |
<15 m-30 m |
<15 m-1 h |
<15 m-1 h |
<15 m-1 h |
<15 m-1 h |
30 m-2 h |
30 m-2 h |
- |
- |
Abnormal position |
<15 m-1 h |
<15 m-30 m |
15 m-30 m |
15 m-1 h |
30 m |
15 m-30 m |
- |
30 m |
- |
- |
Stagger |
1 h-5 h |
- |
<15 m-5 h |
<15 m-5 h |
<15 m-5 h |
<15m-5 h |
15 m-2 h |
15 m-2 h |
- |
- |
Atony |
<15 m-30 m |
<15 m-30 m |
15 m-30 m |
15 m-1 h |
30 m |
30 m |
- |
- |
- |
- |
Twitching |
<15 m-1 h |
<15 m-30 m |
15 m-1 h |
15 m-1 h |
30 m-1 h |
15 m-1 h |
- |
30 m |
- |
- |
Tonic convulsions |
15 m-30 m |
15 m-30 m |
- |
30 m |
- |
- |
- |
- |
- |
- |
Piloerection |
4 h-5 h |
- |
4 h-5 h |
4 h-5 h |
4 h-5 h |
4 h-5 h |
- |
- |
- |
- |
Exophthalmus |
<15 m-1 h |
<15 m-30 m |
15 m-1 h |
15 m-1 h |
30 m-1 h |
15 m-1 h |
- |
- |
- |
- |
Poor general state |
<15 m-1 h |
<15 m-30 m |
<15 m-1 h |
<15 m-1 h |
<15 m-1 h |
<15 m-1 h |
30 m-2 h |
30 m-2 h |
- |
- |
m: minutes
h: hour
d: day
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 410 mg/kg bw
- Quality of whole database:
- Klimisch code 2
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 April to 13 May, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: VELAZ s.r.o, Kolec u Kladna, Czech Republic
- Weight at study initiation: males: 267 - 291 g; females: 167 - 204 g
- Fasting period before study :no
- Housing: individually in plastic cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 26 April 2010 To: 13 May 2010 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6 x 6 cm
- % coverage: 10 % of the body surface
- Type of wrap if used: application site covered by mull and held in place by plaster (strapping)
REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 2000 mg/kg body weight
- For solids, paste formed: no - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations, weighing before application and on days 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic abnormalities at necropsy - Statistics:
- no
- Preliminary study:
- A preliminary study was performed with 1 male and 1 female at 2000 mg/kg body weight. Slight irritation of treated skin in the female on days 2-4 after application.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: Slight irritation of treated skin in 1 female on days 2-4 after application was observed.
- Gross pathology:
- No macroscopic abnormalities.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Guideline and GLP conform studies.
Additional information
Oral Route of Exposure
In the key study, comparable to the OECD guideline 401 (BASF SE, 1983), groups of Wistar rats (10 rats/sex/dose) were given a single oral dose (gavage) of ammonium chloride (analytical purity 99.7 %) in water at dose levels of 681, 1000, 1470, 1780 and 2150 mg/kg bw with a subsequent observation period of 14 days. Dose dependent mortality occurred, with most of the animals dying within 1 hour after application (681 mg/kg bw: 0/20, 1000 mg/kg bw: 3/20, 1470 mg/kg bw: 11/20, 1780 mg/kg bw: 16/20 and 2150 mg/kg bw: 18/20). The LD50 calculated using Probit analysis was 1410 mg/kg bw (1260 – 1550; Slope 1.36). No clinical signs were manifested by animals of the lowest dose group (NOEL clinical signs = 681 mg/kg bw). Clinical signs were seen in animals dosed with 1000 mg/kg bw and above. Clinical symptoms indicated an influence on the central nervous system. Dyspnea, apathy, abnormal position, staggering, twitching, atony, tonic convulsions, poor general state and exophthalmus were observed from 15 min to 2 h post treatment.
Further studies in different mammalian species support the categorisation. An LD50 of 1658 mg/kg bw was determined in rat (Clothier et al., 1987). An LD50 of 1300 mg/kg bw was determined in mouse (Takasaki et al, 1990). An LDLo of 1000 mg/kg bw was determined in rat, sheep and rabbit (Boyd et al., 1946; Singer et al., 1971, Abdernalden`s Handbuch, 1935). In dog, an LDLo of 600 mg/kg bw was determined (Abdernalden`s Handbuch, 1935).
Dermal Route of Exposure
In an acute dermal toxicity study in Wistar rats with ammonium chloride according to the EC B.3 guideline (Agrofert, 2010), the test item was applied to the skin (36 cm²) of 5 animals (male and female) under semi occlusive conditions. After 24 h the test item was removed by cleaning the application site. No mortalities were observed. Slight irritation of treated skin was observed in 1 female on days 2 - 4 after application. No effect on body weight development and no gross macroscopic changes were observed. The LD50 was determined to be above 2000 mg/kg bw. This result is supported by a study with another ammonium ion containing compound, ammonium sulfate (CAS 7783-20-0). No mortality was observed within 14 days in 5 - 6 weeks old Wistar rats (3/sex) receiving an application of 2000 mg/kg bw ammonium sulfate under open conditions (Yamanaka, 1990). The LD50 was also greater than 2000 mg/kg bw.
Inhalative Route of Exposure
As indicated by particle size distribution (granulometry) of the substance, respirable particles which could reach the alveolar region of the lung are not present. Inhalation is therefore not a relevant route of exposure and no testing is required.
Nevertheless, studies with another ammonium ion containing compound, ammonium sulfate (CAS 7783-20 -2) are considered adequate for the assessment of acute inhalation toxicity of ammonium chloride if dusts should be generated that could reach the alveolar region.
The acute inhalation toxicity of ammonium sulfate aerosols (average diameter 1 - 3 µm) is very low with 8 -h LC50 values of greater than 900 mg/m³ for guinea pigs. Rats were exposed repeatedly for 8 h/d to 1000 - 1200 mg/m³ (average diameter 2 - 3 µm) without mortality. No specific signs of toxicity were reported from these studies (Pepelko et al., 1980).
Mucociliary clearance was neither significantly affected in male rabbits that were exposed to 2 mg/m³ for one hour (mass median diameter: 0.4 µm) (Schlesinger, 1984), nor in sheep that were exposed to 1.1 mg/m³ (< 1 µm) for 20 minutes (Sackner et al., 1981) nor in rats exposed to 3.6 mg/m³ (0.4 µm) for 4 h (Phalen et al., 1980).
Pulmonary resistance was slightly increased and compliance was statistical significantly decreased in guinea pigs exposed to 0.5 - 9.5 mg/m³ for one hour (Amdur et al., 1978). Pulmonary mechanics were not altered in dogs breathing ammonium sulfate aerosol at a concentration of 4.1 mg/m³ for 4 h.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Furthermore, the test item is listed in Annex I of Directive 67/548/EEC. As a result the test substance is considered to be classified for acute oral toxicity (GHS Classification Category 4) under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
No classification is warranted for acute dermal or inhalation toxicity, according to Regulation (EC) No 1272/2008, Annex I (CLP).
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