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EC number: 231-635-3 | CAS number: 7664-41-7
- 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
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Anhydrous ammonia is not considered to be genotoxic based on the negative results of in vitro testing (negative bacterial mutation with anhydrous ammonia and diammonium sulphate).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Published, guideline-comparable study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine (S. Typhimurium); tryptophan (E.coli)
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: Deficiency/Proficiency: histidine
- Species / strain / cell type:
- S. typhimurium TA 1537
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: Deficiency/Proficiency: histidine
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: Deficiency/Proficiency: histidine
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: Deficiency/Proficiency: histidine
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- other: Deficiency/Proficiency: tryptophan
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 mix (induced with polychlorinated biphenyl, KC500)
- Test concentrations with justification for top dose:
- 500, 1000, 2500, 5000, 10000 and 25000 ppm
- Vehicle / solvent:
- Air
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterilised air
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA100, TA98, TA1538 without S9.
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterilised air
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- TA1535 and WP2uvrA without S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterilised air
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 without S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterilised air
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- TA100, TA98, TA1537, TA1538 with S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterilised air
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA1535 and WP2uvrA with S9
- Details on test system and experimental conditions:
- Exposure duration: 48 hours. Salmonella typhimurium strains and E. coli were deficient/proficient in histidine and tryptophan. The metabolic activation system was rat liver S9 mix (induced with polychlorinated biphenyl, KC500). Tests were performed in duplicate. The agar plates were exposed without a lid in a glass chamber.
- Evaluation criteria:
- No information
- Statistics:
- No information
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Additional information on results:
- No further information
- Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- Interpretation of results: negative with and without metabolic activation
Ammonia was negative in an Ames test performed similar to OECD 471 with and without metabolic activation. - Executive summary:
The mutagenicity of anydrous ammonia was investigated in a Ames test in S. typhimurium TA98, TA100, TA1535, TA1537 and TA1538) and in E. coli WP2 uvrA. The test method was modified appropriately to investigate a volatile test substance. Studies were performed in duplicate in the presence and absence of an exogenous metabolic activation system (Aroclor 1254 -induced male Sprague-Dawley rat liver S9 fraction). No evidence of mutagenicity was seen under the conditions of this assay.
Reference
Ammonia was negative for genotoxicity in S. typhimurium and E. coli with and without metabolic activation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Anhydrous ammonia is not considered to be genotoxic based on the negative results of in vivo testing (negative Micronucleus test in mice with ammonium chloride).
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See attached read-across justification
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- not specified
- Additional information on results:
- The occurrence of micronucleated erythrocytes after single injection was 0.12%, and after four injections was 0.17%.
- Conclusions:
- Interpretation of results: negative
Read-across substance ammonium chloride was negative for genotoxicity in the mouse micronucleus assay. - Executive summary:
The potential for the genotoxicity of read-across substance ammonium chloride was investigated in a bone marrow micronucleus assay in mice. Male ddY mice were administered ammonium chloride by single intraperitoneal injection at dose levels of 0, 62.5, 125, 250 or 500 mg/kg bw or as four injections within 24 hours at dose levels of 31.3, 62.5, 125 or 250 mg/kg bw. The maximum dose of ammonium chloride was determined by pilot experiments using the multisampling at multi-dose levels method. Dose levels of up to the maximum tolerated dose were used. Mice were killed 24 h after administration and femoral bone marrow cells were harvested, fixed and stained. 1000 PCEs per animal were scored using a light microscope and the number of micronucleated erythrocytes (MnPCEs) recorded. No evidence of genotoxicity was seen under the conditions of this assay.
Reference
The occurrence of micronucleated erythrocytes after single injection was 0.12%, and after four injections was 0.17%.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Genotoxicity in vitro
No evidence of mutagenicity was seen in a key guideline-comparable Ames test performed with anhydrous ammonia in S. typhimurium TA98, TA100, TA1535, TA1537 and TA1538 and in E. coli WP2 uvrA with and without metabolic activation (Shimizu et al,1985) or in a supporting guideline-compliant Ames test with the read-across substance diammonium sulphate in S. typhimurium TA98, TA100, TA1535, TA1537 with and without metabolic activation (BASF, 1989). Similarly, there was no evidence of mutagenicity in a supporting non-standard study using E. coli without metabolic activation (Szybalski, 1958).
Further in vitro testing for clastogenicity and mammalian mutagenicity is waived.
Genotoxicity in vivo
The potential for the genotoxicity of ammonium chloride was investigated in a bone marrow micronucleus assay in mice, dosed by single intraperitoneal injection at dose levels of 0, 62.5, 125, 250 or 500 mg/kg bw or as four injections within 24 hours at dose levels of 31.3, 62.5, 125 or 250 mg/kg bw. The maximum dose of ammonium chloride was determined by pilot experiments using the multisampling at multi-dose levels method. Dose levels of up to the maximum tolerated dose were used. Mice were killed 24 h after administration and femoral bone marrow cells were harvested, fixed and stained. 1000 PCEs per animal were scored using a light microscope and the number of micronucleated erythrocytes (MnPCEs) recorded. No evidence of genotoxicity was seen under the conditions of this assay (Hayashi et al, 1988).
Ammonia is a simple molecule and does not possess any structural alerts for genotoxicity. Ammonia is present at relatively low levels in the systemic circulation as a consequence of protein catabolism (largely in the liver) and is also present at higher levels in the hepatic portal circulation due to the breakdown of urea by gastrointestinal bacteria. The ubiquitous presence of ammonia in the leads to the conclusion that it is unlikely to be genotoxic. The WHO evaluation (EHC 54, 1986) concludes that there is no evidence that ammonia is mutagenic in mammals. A UK Health Protection Agency (HPA) evaluation similarly concludes that ammonia does not have significant mutagenic potential.
Justification for classification or non-classification
No classification according to CLP Regulation 1272/2008/EC is proposed for anhydrous ammonia: there is no evidence for genotoxicity in studies performed in vitro or in vivo.
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