Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 231-635-3 | CAS number: 7664-41-7
Genetic toxicity: in vitro
Administrative data
- 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
Data source
Reference
- Reference Type:
- publication
- Title:
- The Results of Microbial Mutation Test for Forty Three Industrial Chemicals
- Author:
- Shimizu, H., Suzuki, Y., Takemura, N., Goto, S. and Matsushita, H.
- Year:
- 1 985
- Bibliographic source:
- SANGYO IGAKU(JPN J IND HEALTH) 27:400-419,1985
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- Ammonia, anhydrous
- EC Number:
- 231-635-3
- EC Name:
- Ammonia, anhydrous
- Cas Number:
- 7664-41-7
- Molecular formula:
- H3N
- IUPAC Name:
- ammonia
- Details on test material:
- Anhydrous ammonia (CAS 7664-41-7), purity 99.9%.
Constituent 1
Method
- Target gene:
- Histidine (S. Typhimurium); tryptophan (E.coli)
Species / strainopen allclose all
- 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
Controlsopen allclose all
- 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
Results and discussion
Test resultsopen allclose all
- 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
Any other information on results incl. tables
Ammonia was negative for genotoxicity in S. typhimurium and E. coli with and without metabolic activation.
Applicant's summary and conclusion
- 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.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
