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Toxicological information

Genetic toxicity: in vitro

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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:
1985
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

Constituent 1
Chemical structure
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
Constituent 2
Reference substance name:
ammonia anhydrous
IUPAC Name:
ammonia anhydrous
Details on test material:
Anhydrous ammonia (CAS 7664-41-7), purity 99.9%.

Method

Target gene:
No information
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
Not applicable
Additional strain / cell type characteristics:
other: Deficiency/Proficiency: histidine and tryptophan
Species / strain / cell type:
E. coli WP2 uvr A
Additional strain / cell type characteristics:
other: Deficiency/Proficiency: histidine and 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:
Migrated to IUCLID6: 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:
Migrated to IUCLID6: 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:
Migrated to IUCLID6: 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:
Migrated to IUCLID6: 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; 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, TA 1537, TA 98 and 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
Remarks:
Migrated from field 'Test system'.

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 (migrated information):
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.