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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 206-169-9 | CAS number: 305-84-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 991
Materials and methods
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Zinc (2S)-2-(β-alanylamino)-3-(imidazol-1-id-4-yl)propanoate
- EC Number:
- 600-848-7
- Cas Number:
- 107667-60-7
- Molecular formula:
- C9H12N4O3Zn
- IUPAC Name:
- Zinc (2S)-2-(β-alanylamino)-3-(imidazol-1-id-4-yl)propanoate
1
Method
- Target gene:
- trp operon for E. coli strain
Streptomycin dependent bacteria Salmonella typhimurium (SD100)
8 - azaguanine sensitive bacteria Salmonella typhimurium (TM677)
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Species / strain / cell type:
- other: S. typhimurium SD100
- Details on mammalian cell type (if applicable):
- The SD100 strain was isolated from the strain TA100. (obtained from National Institute of Hygienic Sci ences, Tokyo, Japan). SD100 requires a small amount of streptomycin for its growth, and its mutation allows growth in the absence of streptomycin.
- Species / strain / cell type:
- other: S. typhimurium TM677
- Details on mammalian cell type (if applicable):
- The TM677 corresponds to His mutated strain TA100. TM677 mutants are able to growth even in the presence of 8 - azaguanine after treatment with mutagenic chemicals.
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with polychlorobiphenyl (PCB, Aroclor 1254, Monsanto)
- Test concentrations with justification for top dose:
- Experiment: 200, 500, 1000, 2000 or 5000 µg/mL with and without metabolic activation.
- Vehicle / solvent:
- - Vehicle/solvent used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-furyl) - 3-(S-nitro -2-furyl)-acrylamide (AF-2), 2- aminoanthracene (2-AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: For SD100, TM677 pre-incubation, in agar; and WP2 uvrA, in agar
DURATION
- Preincubation period: For SD100 30 min; For TM677 3h
- Exposure duration: at least 48 h
NUMBER OF REPLICATIONS: single experiment
DETERMINATION OF CYTOTOXICITY
- Method: number of survival/ plate (10 -4 x 0.1 mL/plate) - Evaluation criteria:
- Induced mutation frequency was calculated: Control induced mutant - treated induced mutant
- Statistics:
- Mean values were given
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- other: S. typhimurium SD100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- other: S. typhimurium TM677
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- CHOICE OF TESTER STRAINS:
Since the test substance has histidine in its structure, bacteria requiring histidine for the detection of mutagenicity were not applicable. Therefore, the mutagenic acitivity of the test substance was examined in a streptomycin dependent strain SD100, an 8-azaguanine sensitive strain and a WP2 uvrA strain requiring tryptophan.
ADDITIONAL INFORMATION ON CYTOTOXICITY: No toxic effects of the test substance were observed.
Any other information on results incl. tables
Table1: Mutagenicity study of test substance using Salmonella typhimurium SD100.
Compounds |
Concentrations (µg/mL) |
S9 mix |
Number of survival/plate (10-4 x 0.1 mL/plate) |
Smind mutant/plate(0.1 mL/plate) |
Induced mutants/platec |
Induced mutation frequency(Smind/ 105)d |
Control |
|
- |
235.0a |
20.3a |
- |
- ( 0.86)e |
Test substance |
200 |
- |
223.5b |
17.5b |
0 |
0 |
500 |
- |
208.5 |
20.5 |
0.2 |
0.1 |
|
1000 |
- |
237.5 |
18.5 |
0 |
0 |
|
2000 |
- |
267.5 |
21.0 |
0.7 |
0.03 |
|
5000 |
- |
236.0 |
17.0 |
0 |
0 |
|
AF-2 |
0.2 |
- |
187.0 |
94.5 |
74 |
3.97 |
0.05 |
- |
195.0 |
218 |
197.7 |
10.14 |
|
Control |
|
+ |
200.5a |
25.5 |
- |
- (1.27)e |
Test substance |
200 |
+ |
146.5b |
15.5 |
0 |
0 |
500 |
+ |
122.0 |
15.5 |
0 |
0 |
|
1000 |
+ |
176.5 |
16.5 |
0 |
0 |
|
2000 |
+ |
191.0 |
28.5 |
3.0 |
0.16 |
|
5000 |
+ |
169.0 |
25.5 |
0 |
0 |
|
2-AA |
10 |
+ |
167.0 |
89.5 |
64 |
3.83 |
20 |
+ |
124.0 |
124.0 |
98.5 |
7.94 |
|
10 |
- |
236.0 |
18.5 |
0 |
0 |
|
20 |
- |
232.0 |
18.0 |
0 |
0 |
a mean of 4 plates
b mean of 2 plates
c (control Smind mutant) – (treated Smind mutant) if value is minus, the value is zero.
d induced mutants / number of survival
e spontaneous mutation frequency
Table 2: Mutagenicity study of test substance using Salmonella typhimurium TM677.
Compounds |
Concentrations (µg/mL) |
S9 mix |
Number of survival/plate (10-4 x 0.1 mL/plate) |
8-Agr mutant/plate (0.1 mL/105)c |
Induced mutants/plated |
Induced mutation frequency(8-Agr/105)e |
Control |
|
- |
78.0a |
41.0a |
- |
- ( 5.5)f |
Test substance |
200 |
- |
36.5b |
41.0b |
0 |
0 |
500 |
- |
24.5 |
51.0 |
9.0 |
0.1 |
|
1000 |
- |
28.5 |
58.5 |
16.5 |
0 |
|
2000 |
- |
26.5 |
49.0 |
7.0 |
0.03 |
|
5000 |
- |
40.0 |
37.5 |
|
0 |
|
AF-2 |
0.01 |
- |
64.5 |
146.0 |
104.0 |
3.97 |
0.02 |
- |
56.0 |
275.0 |
233.0 |
10.14 |
|
Control |
|
+ |
71.2a |
51.3a |
- |
- (7.2)f |
Test substance |
200 |
+ |
57.0b |
51.5b |
0.2 |
0 |
500 |
+ |
56.0 |
44.0 |
0 |
0 |
|
1000 |
+ |
67.0 |
45.0 |
0 |
0 |
|
2000 |
+ |
54.5 |
62.0 |
10.7 |
2.0 |
|
50000 |
+ |
38.5 |
43.5 |
0 |
0 |
|
2-AA |
2.5 |
+ |
58.5 |
856.0 |
804.7 |
137.6 |
5 |
+ |
33.0 |
817.5 |
766.2 |
232.2 |
|
2.5 |
- |
53.0 |
46.5 |
4.5 |
0.8 |
|
5 |
- |
67.0 |
42.0 |
0 |
0 |
a mean of 6 plates
b mean of 2 plates
c 8-AGrmutant / number of survival
d (control 8 -AGr mutant) – (treated 8 -AGr mutant) if value is minus, the value is zero.
e induced mutants / number of survival
f spontaneous mutation frequency
Table 3: Mutagenicity study of test substance using Escherichia coli WP2 uvrA.
Compounds |
Concentrations (µg/mL) |
S9 mix |
Number of revertants/plate a |
Control |
|
- |
17 |
Test substance |
200 |
- |
25 |
500 |
- |
20 |
|
1000 |
- |
18 |
|
2000 |
- |
18 |
|
5000 |
- |
17 |
|
AF-2 |
0.04 |
- |
415 |
Control |
|
+ |
22 |
Test substance |
200 |
+ |
20 |
500 |
+ |
23 |
|
1000 |
+ |
23 |
|
2000 |
+ |
20 |
|
5000 |
+ |
29 |
|
2-AA |
40 |
+ |
1025 |
a mean of 2 plates
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the conducted test, the substance was not mutagenic in any of the three strains (SD100, TM 677 and WP2 uvrA) tested with and without metabolic activation up to 5000 µg/mL.
- Executive summary:
A bacterial gene mutation assay with the read across substance catena-(S) [µ-[Nα-(3 Aminopropionyl)histidinato(2-)-N1,N2,0:Nτ]- zinc] (CAS 107667 -60 -7)) was performed. Since the test substance has histidine in its structure, bacteria requiring histidine for the detection of mutagenicity were not applicable. In this study, the mutagenic activity of the test substance was examined in a streptomycin dependent S. typhimurium strain SD100, an 8-azaguanine sensitive S. typhimurium strain and the E. coli WP2uvrA strain requiring tryptophan. In this study the RA substance (CAS 107667 -60 -7) was not mutagenic in any of the three strains
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.
