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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Data is from publication.

Data source

Reference
Reference Type:
publication
Title:
Inhibitory Effects of Tea Extracts on the Mutagenicity of 1-Methyl-1,2,3,4-tetrahydro- b-carboline-3-carboxylic Acid on Treatment with Nitrite in the Presence of Ethanol
Author:
M. HIGASHIMOTO1, Y. AKADA1, M. SATO1, T. KINOUCHI2, T. KUWAHARA2 and Y. OHNISHI2
Year:
2000
Bibliographic source:
Food and Chemical Toxicology 38 (2000) 7-13

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mention below
Principles of method if other than guideline:
To evaluate the mutagenic potential of Tyramine in Salmonella typhimurium Strain TA100 by AMES assay.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(2-aminoethyl)phenol
EC Number:
200-115-8
EC Name:
4-(2-aminoethyl)phenol
Cas Number:
51-67-2
Molecular formula:
C8H11NO
IUPAC Name:
4-(2-aminoethyl)phenol
Test material form:
solid: crystalline
Details on test material:
- Name of test material : 4-(2-aminoethyl) phenol
- Common name : Tyramine
- Molecular formula : C8H11NO
- Molecular weight : 137.1809 g/mol
- Smiles notation : NCCc1ccc(O)cc1
- InChl : 1S/C8H11NO/c9-6-5-7-1-3-8(10)4-2-7/h1-4,10H,5-6,9H2
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material : 4-(2-aminoethyl) phenol
- Common name : Tyramine
- Molecular formula : C8H11NO
- Molecular weight : 137.1809 g/mol
- Smiles notation : NCCc1ccc(O)cc1
- InChl : 1S/C8H11NO/c9-6-5-7-1-3-8(10)4-2-7/h1-4,10H,5-6,9H2
- Substance type: Organic
- Physical state: Solid

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium TA 100
Details on mammalian cell type (if applicable):
Not applicable.
Additional strain / cell type characteristics:
not specified
Cytokinesis block (if used):
not specified
Metabolic activation:
without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
20 µg/plate
Vehicle / solvent:
Not specified
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-(2-furyl)-3-(5-nitro-2-furyl)-acryl- amide (AF-2, 10 ng)
Details on test system and experimental conditions:
Details on test system and conditions
METHOD OF APPLICATION: Preincubation Method
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hour

NUMBER OF REPLICATIONS: Duplicate
Rationale for test conditions:
Not specified
Evaluation criteria:
The number of His+ revertants colonies was counted .
Statistics:
The data were analyzed statistically by analysis of variance. The correlation coefficient was calculated by the formula of Pearson.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 100
Metabolic activation:
without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
The mutation was assayed in brown tubes under the yellow lamp in the dark room. The numbers of spontaneous revertants (112±16) were subtracted from all the data on mutagenicity.
A positive control 2-(2-furyl)-3-(5-nitro-2-furyl)-acryl- amide (AF-2, 10 ng) generated 427±65 His+ revertants.
Remarks on result:
other: Mutagenic effect were observed .

Applicant's summary and conclusion

Conclusions:
Tyramine (51-67-2) was evaluated for its mutagenic potential in Salmonella typhimurium Strain TA100 by AMES assay. The test result was considered to be positive in the absence of S9 mix.
Executive summary:

Genetic toxicity study in vitro was assessed for its possible mutagenic potential. For this purpose AMES assay was performed in Salmonella typhimurium Strain TA100 by usingPreincubation Method. The test substance was exposed at the concentration of20 µg/plate in the absence of S9 mix. Mutagenic effects were observed. The AMES test must be performed with and without S9 mix. For a substance to be a mutagen, AMES test should be positive with and without S9 mix. But as in this study the test was performed only in the absence of S9. The test result was considered to be inconclusive as no data available in the presence of S9. Hence further testing should be performed as data is insufficient to classify the substance.