Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 238-173-1 | CAS number: 14281-83-5
- 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
-study according to OECD guideline 471, Zinc bisglycinate was tested for genotoxicity in the Tester strains TA98, TA100, TA102, TA1535 and TA1537 up to the limit concentration of 5000 µg/plate. No cytotoxicity of the test item and no increase of the number of revertants was observed, negative
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019-12-03 to 2020-02-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted July 21st, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his locus
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
S9 Mix
- source of S9 :S9 was obtained by Trinova Biochem GmbH, Gießen. Batch nos. 4115
- method of preparation of S9 mix :produced from the livers of male Sprague-Dawley rats which were treated with 500 mg Aroclor 1254/kg body weight intraperitoneally.
- concentration or volume of S9 mix and S9 in the final culture medium:
S9-Mix
Phosphate buffer 22.5 mL
0.1M NADP-solution 1.0 mL
1M G6P-solution 0.125 mL
Salt solution 0.5 mL
Rat liver S9 1.0 mL
500 µL per 2000 µL top-agar (preincubation method) or 500 µL per 2700µL (plate incorporation method) - Test concentrations with justification for top dose:
- Nominal concentrations: 50, 150, 500, 1500, 5000 µg/plate for the first experiment (plate incorporation)
Nominal concentrations: 78, 156, 313, 625, 1250, 2500, 5000 µg/plate for the second experiment (preincubation method)
Concentrations were based on preliminary tests - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: aqueous solvents (water)
- Justification for choice of solvent/vehicle: Based on the non-GLP pre-test, a test item suspension in demin. water was used, be-
cause this solvent shows the most stable suspension with the test item and does not have any effects on the viability of the bacteria or the number of spontaneous revertants in the tested concentrations.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene diamine; without metabolic activation; 20 µg in DMSO for TA 98 and 30 µg for TA102 and TA1537; 2-Amino-anthracene; with metabolic activation; 1 µg in DMSO for TA100, TA1535 and 2.4 µg in DMSO for TA 102, TA1537
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration (single, duplicate, triplicate) : Treatment with test item: triplicates; Spontaneous revertants: triplicates; Determination of titre: duplicates; Toxicity control: duplicates; Sterility control: four replicates; Positive controls: triplicates
- Number of independent experiments : two
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): at least E+09 cells/mL
- Test substance added in medium; in agar (plate incorporation, experiment one) and preincubation (experiment two)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 min at 37 ± 1°C
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: background growth inhibition - Rationale for test conditions:
- As recommended by OECD guideline 471
- Evaluation criteria:
- Five different analysable and non-toxic concentrations should be used for the evaluation of the mutagenic potential of the test item.
A substance is considered to be mutagenic, if a reproducible increase with or without metabolic activation of revertant colonies per plate exceeding an increase factor of 2 for the bacteria strains TA98, TA100, TA102, TA1535 and TA1537 compared to vehicle controls
in at least one strain can be observed.
A concentration-related increase over the range tested is also taken as a sign of mutagenic activity.
A substance is not mutagenic if it does not meet these criteria. If the criteria listed above are not clearly met, the results will be assessed as equivocal and will be discussed. - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: sufficient for using demin. water as vehicle
- Precipitation and time of the determination: Not observed
RANGE-FINDING/SCREENING STUDIES (if applicable): Preliminary non-GLP test to determine the solubility of the test item
STUDY RESULTS
- Concurrent vehicle negative and positive control data
Please refer to the 'Any other information on results incl. tables' section
For all test methods and criteria for data analysis and interpretation:
- Concentration-response relationship where possible : Due to lack of toxicity and mutagenicity not possible.
Ames test:
- Signs of toxicity : No signs of toxicity
HISTORICAL CONTROL DATA (with ranges, means and standard deviation, and 95% control limits for the distribution as well as the number of data)
- Positive historical control data: Please refer to the 'Any other information on results incl. tables' section
- Negative (solvent/vehicle) historical control data: Please refer to the 'Any other information on results incl. tables' section - Conclusions:
- Based on the results of this studyconducted according to OECD guideline 471 it is concluded that the test item Zinc bisglycinate is not mutagenic in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 in the presence and absence of metabolic activation under the experimental conditions in this study.
- Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471 (1997), Salmonella typhimurium strains TA98, TA100, TA102,TA1535 and TA1537 in the presence and absence of metabolic activation were exposed to Zinc bisglycinate in demin. water and DMSO, respectively, at concentrations of 50, 150, 500, 1500 and 5000 µg/plate (pre-incubation method) and to 78, 156, 313, 625, 1250, 2500 and 5000 µg/plate (plate incorporation method).
Zinc bisglycinate was tested up to limit concentration of 5000 µg/plate, there was no evidence of induced mutant colonies over background.
The positive controls induced the appropriate responses in the corresponding strains.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data. Thus, the test item is not classified as mutagen according to Regulation (EC) No. 1272/2008 (CLP) or the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
Reference
Spontaneous Revertants demin. water (colonies per plate) Demin. water; experiment 1
Strain |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
|||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Repl. 1 |
15 |
18 |
62 |
70 |
280 |
280 |
9 |
17 |
8 |
9 |
Repl. 2 |
13 |
10 |
78 |
72 |
248 |
272 |
9 |
17 |
8 |
10 |
Repl. 3 |
18 |
17 |
72 |
76 |
264 |
272 |
12 |
19 |
6 |
8 |
Mean |
15 |
15 |
71 |
73 |
264 |
275 |
10 |
18 |
7 |
9 |
sd |
2.5 |
4.4 |
8.1 |
3.1 |
16.0 |
4.6 |
1.7 |
1.2 |
1.2 |
1.0 |
Spontaneous Revertants demin. water (colonies per plate) Demin. water; experiment 2
Strain |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
|||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Repl. 1 |
19 |
20 |
96 |
96 |
352 |
368 |
9 |
10 |
6 |
9 |
Repl. 2 |
20 |
19 |
92 |
92 |
384 |
384 |
12 |
10 |
5 |
7 |
Repl. 3 |
20 |
19 |
84 |
80 |
376 |
376 |
10 |
11 |
4 |
7 |
Mean |
20 |
19 |
91 |
89 |
371 |
376 |
10 |
10 |
5 |
8 |
sd |
0.6 |
0.6 |
6.1 |
8.3 |
16.7 |
8.0 |
1.5 |
0.6 |
1.0 |
1.2 |
Spontaneous Revertants demin. water (colonies per plate) DMSO, experiment 1
Strain |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
|||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Repl. 1 |
11 |
15 |
60 |
62 |
256 |
288 |
15 |
15 |
11 |
8 |
Repl. 2 |
14 |
13 |
62 |
80 |
272 |
264 |
17 |
10 |
8 |
9 |
Repl. 3 |
14 |
19 |
58 |
66 |
248 |
280 |
18 |
14 |
8 |
8 |
Mean |
13 |
16 |
60 |
69 |
259 |
277 |
17 |
13 |
9 |
8 |
sd |
1.7 |
3.1 |
2.0 |
9.5 |
12.2 |
12.2 |
1.5 |
2.6 |
1.7 |
0.6 |
Spontaneous Revertants demin. water (colonies per plate) DMSO, experiment 2
Strain |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
|||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Repl. 1 |
18 |
19 |
76 |
80 |
352 |
360 |
9 |
11 |
6 |
9 |
Repl. 2 |
18 |
20 |
80 |
84 |
360 |
368 |
8 |
15 |
6 |
6 |
Repl. 3 |
18 |
21 |
88 |
84 |
352 |
368 |
10 |
10 |
6 |
8 |
Mean |
18 |
20 |
81 |
83 |
355 |
365 |
9 |
12 |
6 |
8 |
sd |
0.0 |
1.0 |
6.1 |
2.3 |
4.6 |
4.6 |
1.0 |
2.6 |
0.0 |
1.5 |
Historical Data of Spontaneous Revertants
Strain |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. Water |
Mean |
28 |
30 |
91 |
96 |
303 |
318 |
15 |
15 |
6 |
8 |
Min |
6 |
8 |
46 |
53 |
85 |
67 |
6 |
6 |
3 |
5 |
|
Max |
93 |
109 |
147 |
141 |
509 |
587 |
36 |
40 |
15 |
22 |
|
SD |
16 |
15 |
16 |
16 |
70 |
77 |
6 |
6 |
2 |
2 |
|
Exp1 |
15 |
15 |
71 |
73 |
264 |
275 |
10 |
18 |
7 |
9 |
|
Exp2 |
20 |
19 |
91 |
89 |
371 |
376 |
10 |
10 |
5 |
8 |
|
DMSO |
Mean |
28 |
29 |
88 |
91 |
302 |
311 |
15 |
15 |
6 |
7 |
Min |
7 |
8 |
37 |
42 |
79 |
80 |
6 |
6 |
4 |
4 |
|
Max |
104 |
108 |
143 |
199 |
531 |
499 |
35 |
37 |
15 |
20 |
|
SD |
16 |
15 |
16 |
17 |
70 |
69 |
6 |
6 |
4 |
4 |
|
Exp1 |
13 |
16 |
60 |
69 |
259 |
277 |
17 |
13 |
9 |
8 |
|
Exp2 |
18 |
20 |
81 |
83 |
355 |
365 |
9 |
12 |
6 |
8 |
|
Positive controls |
Mean |
433 |
188 |
529 |
829 |
1138 |
1209 |
289 |
151 |
124 |
111 |
Min |
77 |
39 |
218 |
273 |
491 |
408 |
55 |
45 |
79 |
100 |
|
Max |
s.g. |
s.g. |
1256 |
1912 |
2331 |
6083 |
s.g. |
s.g. |
165 |
123 |
|
SD |
219 |
159 |
214 |
275 |
364 |
473 |
119 |
106 |
17 |
7 |
|
Exp1 |
s.g. |
98 |
s.g. |
s.g. |
605 |
s.g. |
221 |
175 |
232 |
168 |
|
Exp2 |
s.g. |
111 |
s.g. |
s.g. |
765 |
872 |
248 |
167 |
152 |
160 |
Mean Revertants First Experiment (1)
Strain |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. Water |
Mean |
15 |
15 |
71 |
73 |
264 |
275 |
10 |
18 |
7 |
9 |
SD |
2.5 |
4.4 |
8.1 |
3.1 |
16.0 |
4.6 |
1.7 |
1.2 |
1.2 |
1.0 |
|
DMSO |
Mean |
13 |
16 |
60 |
69 |
259 |
277 |
17 |
13 |
9 |
8 |
SD |
1.7 |
3.1 |
2.0 |
9.5 |
12.2 |
12.2 |
1.5 |
2.6 |
1.7 |
0.6 |
|
Positive controls |
Mean |
s.g. |
98 |
s.g. |
s.g. |
605 |
s.g. |
221 |
175 |
232 |
168 |
SD |
-- |
17.1 |
-- |
-- |
28.1 |
-- |
6.1 |
4.6 |
8.0 |
21.2 |
|
f(l) |
> 2 |
6.13 |
> 2 |
> 2 |
2.34 |
> 2 |
22.10 |
13.46 |
25.78 |
21.00 |
|
5000µg/plate |
Mean |
15 |
19 |
125 |
120 |
256 |
256 |
13 |
13 |
9 |
12 |
SD |
0.6 |
2.9 |
5.0 |
8.0 |
16.0 |
13.9 |
1.2 |
2.5 |
1.2 |
1.5 |
|
f(l) |
1.00 |
1.27 |
1.76 |
1.64 |
0.97 |
0.93 |
1.30 |
0.72 |
1.29 |
1.33 |
|
1500 µg/plate |
Mean |
17 |
17 |
94 |
107 |
253 |
269 |
11 |
14 |
12 |
9 |
SD |
3.8 |
2.5 |
7.2 |
4.6 |
18.5 |
20.1 |
1.5 |
2.3 |
2.5 |
0.6 |
|
f(l) |
1.13 |
1.13 |
1.32 |
1.47 |
0.96 |
0.98 |
1.10 |
0.78 |
1.71 |
1.00 |
|
500 µg/plate |
Mean |
12 |
15 |
67 |
89 |
272 |
264 |
11 |
12 |
9 |
10 |
SD |
2.5 |
3.1 |
1.2 |
2.3 |
16.0 |
8.0 |
2.1 |
0.6 |
0.6 |
1.5 |
|
f(l) |
0.80 |
1.00 |
0.94 |
1.22 |
1.03 |
0.96 |
1.10 |
0.67 |
1.29 |
1.11 |
|
150 µg/plate |
Mean |
13 |
13 |
62 |
65 |
267 |
261 |
12 |
13 |
9 |
8 |
SD |
3.1 |
4.0 |
2.0 |
5.0 |
12.2 |
18.5 |
1.7 |
0.6 |
1.2 |
1.0 |
|
f(l) |
0.87 |
0.87 |
0.87 |
0.89 |
1.01 |
0.95 |
1.20 |
0.72 |
1.29 |
0.89 |
|
50 g/plate |
Mean |
10 |
14 |
62 |
63 |
264 |
264 |
12 |
12 |
10 |
10 |
|
SD |
1.7 |
3.0 |
2.0 |
3.1 |
8.0 |
0.0 |
0.6 |
2.1 |
2.1 |
2.1 |
|
f(l) |
0.67 |
0.93 |
0.87 |
0.86 |
1.00 |
096 |
1.20 |
0.67 |
1.43 |
1.11 |
Mean Revertants Second Experiment (2)
Strain |
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
Demin. Water |
Mean |
20 |
19 |
91 |
89 |
371 |
376 |
10 |
10 |
5 |
8 |
SD |
0.6 |
0.6 |
6.1 |
8.3 |
16.7 |
8.0 |
1.5 |
0.6 |
1.0 |
1.2 |
|
DMSO |
Mean |
18 |
20 |
81 |
83 |
355 |
365 |
9 |
12 |
6 |
8 |
SD |
0.0 |
1.0 |
6.1 |
2.3 |
4.6 |
4.6 |
1.0 |
2.6 |
0.0 |
1.5 |
|
Positive controls |
Mean |
s.g. |
111 |
s.g. |
s.g. |
765 |
872 |
248 |
167 |
152 |
160 |
SD |
-- |
2.3 |
-- |
-- |
12.2 |
21.2 |
13.9 |
2.3 |
18.3 |
13.9 |
|
f(l) |
> 2 |
5.55 |
> 2 |
> 2 |
2.15 |
2.39 |
24.80 |
13.92 |
25.33 |
20.00 |
|
5000µg/plate |
Mean |
19 |
24 |
108 |
108 |
368 |
349 |
10 |
12 |
7 |
8 |
SD |
1.5 |
1.0 |
4.0 |
4.0 |
8.0 |
4.6 |
0.6 |
2.1 |
1.5 |
1.0 |
|
f(l) |
0.95 |
1.26 |
1.19 |
1.21 |
0.99 |
0.93 |
1.00 |
1.20 |
1.40 |
1.00 |
|
2500 g/plate |
Mean |
19 |
21 |
92 |
88 |
363 |
349 |
13 |
12 |
7 |
8 |
SD |
1.0 |
1.0 |
4.0 |
6.9 |
23.1 |
12.2 |
1.5 |
1.7 |
2.1 |
0.6 |
|
f(l) |
0.95 |
1.11 |
1.01 |
0.99 |
0.98 |
0.93 |
1.30 |
1.20 |
1.40 |
1.00 |
|
1250µg/plate |
Mean |
18 |
20 |
89 |
97 |
373 |
355 |
10 |
11 |
6 |
6 |
SD |
1.0 |
1.2 |
8.3 |
6.1 |
12.2 |
18.5 |
0.6 |
1.0 |
0.6 |
1.0 |
|
f(l) |
0.90 |
1.05 |
0.98 |
1.09 |
1.01 |
0.94 |
1.00 |
1.10 |
1.20 |
0.75 |
|
625 µg/plate |
Mean |
19 |
22 |
87 |
95 |
360 |
368 |
10 |
8 |
7 |
6 |
SD |
0.6 |
1.0 |
2.3 |
2.3 |
8.0 |
16.0 |
1.0 |
1.0 |
1.5 |
1.7 |
|
f(l) |
0.95 |
1.16 |
0.96 |
1.07 |
0.97 |
0.98 |
1.00 |
0.80 |
1.40 |
0.75 |
|
313 µg/plate |
Mean |
19 |
18 |
87 |
92 |
355 |
347 |
9 |
10 |
5 |
6 |
SD |
1.2 |
0.6 |
2.3 |
4.0 |
16.7 |
16.7 |
1.0 |
2.0 |
0.6 |
0.6 |
|
f(l) |
0.95 |
0.95 |
0.96 |
1.03 |
0.96 |
0.92 |
0.90 |
1.00 |
1.00 |
0.75 |
|
156 g/plate |
Mean |
19 |
22 |
87 |
95 |
360 |
368 |
10 |
8 |
7 |
6 |
SD |
0.6 |
1.0 |
2.3 |
2.3 |
8.0 |
16.0 |
1.0 |
1.0 |
1.5 |
1.7 |
|
f(l) |
0.95 |
1.16 |
0.96 |
1.07 |
0.97 |
0.98 |
1.00 |
0.80 |
1.40 |
0.75 |
|
78 g/plate |
Mean |
19 |
18 |
87 |
92 |
355 |
347 |
8 |
10 |
5 |
6 |
SD |
1.2 |
0.6 |
2.3 |
4.0 |
16.7 |
16.7 |
0.6 |
2.0 |
0.6 |
0.6 |
|
f(l) |
0.95 |
0.95 |
0.96 |
1.03 |
0.96 |
0.92 |
0.80 |
1.00 |
1.00 |
0.75 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
In a reverse gene mutation assay in bacteria according to OECD guideline 471 (1997), Salmonella typhimurium strains TA98, TA100, TA102,TA1535 and TA1537 in the presence and absence of metabolic activation were exposed to Zinc bisglycinate in demin. water and DMSO, respectively, at concentrations of 50, 150, 500, 1500 and 5000 µg/plate (pre-incubation method) and to 78, 156, 313, 625, 1250, 2500 and 5000 µg/plate (plate incorporation method).
Zinc bisglycinate was tested up to limit concentration of 5000 µg/plate, there was no evidence of induced mutant colonies over background.
The positive controls induced the appropriate responses in the corresponding strains.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data. Thus, the test item is not classified as mutagen according to Regulation (EC) No. 1272/2008 (CLP) or the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
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.