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EC number: 248-328-5 | CAS number: 27214-00-2
- 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
The test item Calcium glycerophosphate was assessed for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) usingSalmonella typhimuriumstrains TA 1535, TA 1537, TA 98, TA 100, and theEscherichia colistrain WP2 uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II: 33; 100; 333; 1000; 2500; and 5000 µg/plate
The test item precipitated in the overlay agar in the test tubes at 5000 µg/plate. Precipitation of the test item in the overlay agar on the incubated agar plates was observed at 5000 µg/plate. The undissolved particles had no influence on the data recording.
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
One single minor toxic effect, evident as a reduction in the number of revertants (below the indication factor of 0.5), was observed in experiment I in strain TA98 without S9 mix at 5000 µg/plate. No other toxic effects occurred in in the remaining test groups neither with nor and without metabolic activation.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Calcium glycerophosphate at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-08-16 till 2017-08-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline-conform study under GLP without deviations
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- IIdentification: Calcium glycerophosphate
Batch: CGP0416003
CAS No.: 27214-00-2
EINECS No. / EC No.: Not available
Purity: 85.9% (w/w) Calcium 2,3-dihydroxypropyl phosphate
5.8% (w/w)Calcium 1,3-dihydroxypropyl phosphate
8.3% Water
The product can be regarded as a pure substance
Physical State / Appearance: Solid white
Stability in solvent: Not indicated by the Sponsor
Expiry Date: 29 June 2021
Storage Conditions: At room temperature, moisture protected, light protected*
Purpose of Use: Industrial chemical
* only valid for storage condition, not for test performance
No correction for purity was made. - Species / strain / cell type:
- other: TA 1535, TA 1537, TA 98, TA 100, and WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/Beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II: 33; 100; 333; 1000; 2500; and 5000 µg/plate - Vehicle / solvent:
- Solvent used: DMSO
Justification for choice of solvent: best suitable solvent, because of its solubility properties and its relative nontoxicity to the bacteria - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar plate incorporation; pre-incubation
DURATION:
Preincubation period: 600 Minutes
exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 plates for each concentration including the controls
DETERMINATION OF CYTOTOXICITY: Evident as a reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn. - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
- Key result
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100, and WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Strain TA 98 without S9 mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST SPECIFIC CONFOUNDING FACTORS
Effects of pH: none
Water solubility: not soluble
Precipitation: The test item precipitated in the overlay agar in the test tubes at 5000 µg/plate. Precipitation of the test item in the overlay agar on the incubated agar plates was observed at 5000 µg/plate. The undissolved particles had no influence on the data recording.
Other confounding effects: none
COMPARISON WIT HISTORICAL CONTROL DATA: performed; no deviations
ADDITIONAL INFORMATION ON CYTOTOXICITY: experiment I: strain TA98 without S9 mix at 5000 µg/plate. - Remarks on result:
- other: reverse mutation assay migrated from the field Test System
- Conclusions:
- During the described mutagenicity test (Ames-test) and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, Calcium glycerophosphate is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay. - Executive summary:
The test item Calcium glycerophosphate was assessed for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) usingSalmonella typhimuriumstrains TA 1535, TA 1537, TA 98, TA 100, and theEscherichia colistrain WP2 uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II: 33; 100; 333; 1000; 2500; and 5000 µg/plate
The test item precipitated in the overlay agar in the test tubes at 5000 µg/plate. Precipitation of the test item in the overlay agar on the incubated agar plates was observed at 5000 µg/plate. The undissolved particles had no influence on the data recording.
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
One single minor toxic effect, evident as a reduction in the number of revertants (below the indication factor of 0.5), was observed in experiment I in strain TA98 without S9 mix at 5000 µg/plate. No other toxic effects occurred in in the remaining test groups neither with nor and without metabolic activation.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Calcium glycerophosphate at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
Reference
Summary of Experiment I
Study Name: 1855513 |
Study Code: Envigo 1855513 |
Experiment: 1855513 VV Plate |
Date Plated: 16.08.2017 |
Assay Conditions: |
Date Counted: 21.08.2017 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
TA 1535 Revertant Colony Counts (Mean ±SD) |
TA 1537 Revertant Colony Counts (Mean ±SD) |
TA 98 Revertant Colony Counts (Mean ±SD) |
TA 100 Revertant Colony Counts (Mean ±SD) |
WP2 uvrA Revertant Colony Counts (Mean ±SD) |
|
|
|
|
|
|
|
|
Without |
DMSO |
|
11 ± 4 |
10 ± 1 |
25 ± 2 |
200 ± 7 |
34 ± 5 |
Activation |
Untreated |
|
10 ± 3 |
10 ± 5 |
24 ± 4 |
195 ± 23 |
32 ± 6 |
|
Calcium |
3 µg |
11 ± 3 |
11 ± 1 |
21 ± 1 |
170 ± 8 |
35 ± 6 |
|
glycerophosphate |
10 µg |
10 ± 4 |
11 ± 3 |
19 ± 3 |
156 ± 13 |
32 ± 1 |
|
|
33 µg |
11 ± 4 |
11 ± 5 |
21 ± 8 |
173 ± 25 |
32 ± 6 |
|
|
100 µg |
9 ± 2 |
10 ± 1 |
25 ± 2 |
173 ± 11 |
33 ± 3 |
|
|
333 µg |
9 ± 2 |
11 ± 5 |
25 ± 2 |
163 ± 27 |
33 ± 2 |
|
|
1000 µg |
8 ± 4 |
11 ± 4 |
24 ± 7 |
181 ± 6 |
33 ± 7 |
|
|
2500 µg |
11 ± 4 |
8 ± 5 |
23 ± 5 |
181 ± 7 |
29 ± 2 |
|
|
5000 µg |
12 ± 3P M |
7 ± 3P M |
11 ± 4P M |
170 ± 8P |
32 ± 3P |
|
NaN3 |
10 µg |
1104 ± 35 |
|
|
1736 ± 257 |
|
|
4-NOPD |
10 µg |
|
|
417 ± 21 |
|
|
|
4-NOPD |
50 µg |
|
95 ± 7 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
762 ± 25 |
|
|
|
|
|
|
|
|
With |
DMSO |
|
12 ± 2 |
14 ± 3 |
35 ± 5 |
165 ± 15 |
51 ± 5 |
Activation |
Untreated |
|
16 ± 4 |
15 ± 5 |
43 ± 3 |
175 ± 6 |
45 ± 2 |
|
Calcium |
3 µg |
12 ± 4 |
12 ± 3 |
42 ± 2 |
171 ± 12 |
50 ± 6 |
|
glycerophosphate |
10 µg |
16 ± 5 |
18 ± 3 |
38 ± 2 |
162 ± 3 |
44 ± 6 |
|
|
33 µg |
14 ± 6 |
12 ± 2 |
43 ± 14 |
156 ± 8 |
41 ± 15 |
|
|
100 µg |
9 ± 2 |
19 ± 4 |
44 ± 7 |
153 ± 6 |
42 ± 12 |
|
|
333 µg |
14 ± 4 |
24 ± 3 |
44 ± 4 |
154 ± 9 |
41 ± 10 |
|
|
1000 µg |
16 ± 2 |
16 ± 3 |
40 ± 3 |
156 ± 8 |
56 ± 11 |
|
|
2500 µg |
15 ± 6 |
19 ± 3 |
40 ± 10 |
129 ± 26 |
49 ± 1 |
|
|
5000 µg |
8 ± 2P M |
9 ± 3P M |
21 ± 5P M |
140 ± 7P |
55 ± 11P |
|
2-AA |
2.5 µg |
384 ± 5 |
169 ± 14 |
3756 ± 752 |
2808 ± 53 |
|
|
2-AA |
10.0 µg |
|
|
|
|
430 ± 21 |
|
|
|
|
|
|
|
|
Summary of Experiment II
Study Name: 1855513 |
Study Code: Envigo 1855513 |
Experiment: 1855513 HV2 Pre |
Date Plated: 23.08.2017 |
Assay Conditions: |
Date Counted: 30.08.2017 |
Metabolic Activation |
Test Group |
Dose Level (per plate |
TA 1535 Revertant Colony Counts (Mean ±SD) |
TA 1537 Revertant Colony Counts (Mean ±SD) |
TA 98 Revertant Colony Counts (Mean ±SD) |
TA 100 Revertant Colony Counts (Mean ±SD) |
WP2 uvrA Revertant Colony Counts (Mean ±SD) |
|
|
|
|
|
|
|
|
Without |
DMSO |
|
12 ± 2 |
10 ± 4 |
26 ± 3 |
112 ± 16 |
37 ± 1 |
Activation |
Untreated |
|
10 ± 2 |
12 ± 2 |
23 ± 3 |
156 ± 20 |
40 ± 7 |
|
Calcium |
33 µg |
15 ± 1 |
11 ± 4 |
32 ± 6 |
98 ± 7 |
38 ± 4 |
|
glycerophosphate |
100 µg |
14 ± 3 |
7 ± 2 |
22 ± 6 |
105 ± 4 |
42 ± 5 |
|
|
333 µg |
11 ± 4 |
10 ± 1 |
32 ± 2 |
114 ± 8 |
37 ± 3 |
|
|
1000 µg |
14 ± 2 |
11 ± 2 |
25 ± 7 |
94 ± 19 |
42 ± 6 |
|
|
2500 µg |
11 ± 3 |
10 ± 2 |
27 ± 1 |
110 ± 1 |
43 ± 4 |
|
|
5000 µg |
11 ± 1P |
6 ± 4P |
29 ± 6P |
106 ± 3P |
42 ± 9P |
|
NaN3 |
10 µg |
1035 ± 64 |
|
|
1932 ± 93 |
|
|
4-NOPD |
10 µg |
|
|
422 ± 39 |
|
|
|
4-NOPD |
50 µg |
|
101 ± 3 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
667 ± 57 |
|
|
|
|
|
|
|
|
With |
DMSO |
|
10 ± 6 |
13 ± 3 |
34 ± 7 |
100 ± 24 |
48 ± 5 |
Activation |
Untreated |
|
9 ± 2 |
13 ± 3 |
50 ± 2 |
129 ± 7 |
52 ± 6 |
|
Calcium |
33 µg |
10 ± 4 |
12 ± 3 |
37 ± 11 |
93 ± 9 |
47 ± 9 |
|
glycerophosphate |
100 µg |
10 ± 1 |
14 ± 2 |
31 ± 6 |
103 ± 19 |
54 ± 6 |
|
|
333 µg |
11 ± 4 |
16 ± 2 |
42 ± 13 |
91 ± 18 |
50 ± 11 |
|
|
1000 µg |
7 ± 2 |
18 ± 2 |
28 ± 6 |
101 ± 12 |
45 ± 10 |
|
|
2500 µg |
10 ± 1 |
14 ± 5 |
37 ± 9 |
93 ± 11 |
55 ± 3 |
|
|
5000 µg |
12 ± 2P |
15 ± 3P |
36 ± 5P |
115 ± 19P |
57 ± 1P |
|
2-AA |
2.5 µg |
310 ± 37 |
105 ± 6 |
3738 ± 713 |
2456 ± 474 |
|
|
2-AA |
10.0 µg |
|
|
|
|
393 ± 15 |
|
|
|
|
|
|
|
|
Key to Plate Postfix Codes:
P: Precipitate
M: Manuel Count
Key to positive controls:
NaN3: sodium azide
4 -NOPD: 4 -nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
2-AA: 2 -aminoanthracene
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available (further information necessary)
Additional information
Justification for classification or non-classification
no classification
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Calcium glycerophosphate at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix).
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.
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