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EC number: - | CAS number: -
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-01-30 to 1990-06-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Escherichia coli strain not tested
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of dodecyldiphenyl phosphate and tetradecyldiphenyl phosphate
- Molecular formula:
- CH24H35O4P.C26H39O4P
- IUPAC Name:
- Reaction mass of dodecyldiphenyl phosphate and tetradecyldiphenyl phosphate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Purity: 90-95%
Lot no: DEEUGEA NBP#4321285
EHL Test sample T900009
Stated expiration date: January 1991
Storage conditions: Room Temperature
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Details on mammalian cell type (if applicable):
- CELLS USED
- Type and source of cells:
Salmonella typhimurium strains TA1535 were obtained from the Laboratory of Dr. B. N. Ames (Berkeley, California). - Additional strain / cell type characteristics:
- other: Proper phenotype of each culture was verified for cyrstal violet sensitivity, ampicillin resistance, requirement for histidine and biotin, and spontaneous reversion frequency.
- Species / strain / cell type:
- S. typhimurium TA 1537
- Details on mammalian cell type (if applicable):
- CELLS USED
- Type and source of cells:
Salmonella typhimurium strains TA1537 were obtained from the Laboratory of Dr. B. N. Ames (Berkeley, California). - Additional strain / cell type characteristics:
- other: Proper phenotype of each culture was verified for cyrstal violet sensitivity, ampicillin resistance, requirement for histidine and biotin, and spontaneous reversion frequency.
- Species / strain / cell type:
- S. typhimurium TA 98
- Details on mammalian cell type (if applicable):
- CELLS USED
- Type and source of cells:
Salmonella typhimurium strains TA98, were obtained from the Laboratory of Dr. B. N. Ames (Berkeley, California). - Additional strain / cell type characteristics:
- other: Proper phenotype of each culture was verified for cyrstal violet sensitivity, ampicillin resistance, requirement for histidine and biotin, and spontaneous reversion frequency.
- Species / strain / cell type:
- S. typhimurium TA 100
- Details on mammalian cell type (if applicable):
- CELLS USED
- Type and source of cells:
Salmonella typhimurium strains TA100, were obtained from the Laboratory of Dr. B. N. Ames (Berkeley, California). - Additional strain / cell type characteristics:
- other: Proper phenotype of each culture was verified for cyrstal violet sensitivity, ampicillin resistance, requirement for histidine and biotin, and spontaneous reversion frequency.
- Metabolic activation:
- with and without
- Metabolic activation system:
- - source of S9
: S9 preparation was purchased from Molecular Toxicology Inc. (College Park, Maryland)
- method of preparation of S9 mix : Prepared from livers of Aroclor-1254 induced male Sprague-Dawley rats (Hilltop Laboratories, Scottsdale, PA). Prepared using procedure described by Ames et al. 1975.
- concentration or volume of S9 mix and S9 in the final culture medium: 10% v/v
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): S9 was tested for metabolic activation capability in a matrix experiment in which both percent S9 in S9 mix and the amount of positive standard per plate were varied. - Test concentrations with justification for top dose:
- 0.03, 0.10, 0.30, 1.00, and 3.00 mg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: anhydrous acetone
- Justification for choice of solvent/vehicle: Not specified
- Justification for percentage of solvent in the final culture medium: Not specified
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- benzo(a)pyrene
- other: Sodium Nitrite (-S9: TA1535); 2-aminoanthracene (+S9: TA1535 and TA1537)
- Details on test system and experimental conditions:
- General procedures were basically those described by Ames et al.
Doses used per plate with/without S-9 were 0.1, 0.3, 1.0, 3.0, and 5.0 mg (Toxicity Screen). Based on the toxicity and insolubilty observed in the toxicity screen, the maximum dose level for mutagenicity testing was selected as 3 mg/plate.
Plate incorporation tests were performed by mixing 0.1 ml of bacterial culture, and. if appropriate. 0.5 ml of S-9 mix with 2 ml of histidine-biotin top agar (0.5% (w/v) NaCl, 0.6% (w/v) Difco agar, 0.05 mM L-histidine-HCl, 0.05 mM biotin) maintained at 44-48 degrees C. THe mixture was poured onto minimal glucose agar plates (Vogel-Bonner medium E with 2% glucose and 1.5% Difco agar). Toxicity tests employed the same procedures as those used in the plate incorporation test. Single plates were prepared for each strain/S-9/dose level combination for the toxicity test. 3 replicate plates were prepared for each strain/S-9/combination for the plate incorporation tests. Concurrent positive and negative controls were conducted for plate incorporation tests to demonstrate strain sensitivity and metabolic activation system capability. Plates were examined after at least 48 hours at 37 degrees Cl. A screen for suitable solvents, for the possibility of pH or osmolality effects, and for reaction with plastic petri dishes was performed prior to the plate incorporation tests.
Revertant colonies for plates with more than 500 revertant colonies/plate were estimated by counting revertant colonies in several fields under a stereomicroscope and multiplying the counted colonies by a factor related the total plate area to the area of the counted fields. Revertant colonies measured in this manner are calculated to not more than three significant figures. Revertant colonies on other plates, except as noted, were counted with an Artek Model 880 automatic colony counter or counted by visual examination (<10 revertants/plate). - Evaluation criteria:
- Results were considered to be clearly positive for a strain/microsome combination if revertants/plate values were significantly elevated over control values (p<0.01) at three treatment levels, and there was a statistically significant dose response (p<0.01).
- Statistics:
- Statistical analysis was performed on plate incorporation assay results after transforming revertants/plate values as log10(revertants/plate). Analysis included Bartlett's test for homogeneity of variance and comparison of treatrments with controls using within-levels pooled variance and a one-sided t-test. Grant's test was performed to determine if outliers were present. Statistical significance of dose response was evaluated by regression analysis for log 10 transformed values and revertants plate.
A critical level of p<0.01 was used to determine statistical significance. Results with P<0.05 were also indicated to assist in interpretation of results.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. Toxicity Test Results with test strain TA100
Amount of test material per plate (mg) |
S-9* |
Toxic Response** |
Solubility† |
0.1 |
- |
N |
S |
0.1 |
+ |
N |
S |
0.3 |
- |
N |
S |
0.3 |
+ |
N |
S |
1.0 |
- |
N |
S |
1.0 |
+ |
N |
S |
3.0 |
- |
T |
I |
3.0 |
+ |
T |
I |
5.0 |
- |
T |
I |
5.0 |
+ |
T |
I |
* = S-9 Mix was prepared using 10% (v/v) rat liver S-9 preparation (MolTox 02337) in the S-9 Mix
** = N = No toxic response; T = Toxicity observed
† = S = Test material soluble; I = Test material insoluble
Table 2. Statistical summary of plate incorporation test results for TA98 and TA100 with and without S9
Strain |
TA98 |
TA98 |
TA100 |
TA100 |
Activation System |
With S-9 |
None |
With S-9 |
None |
Test Date |
09-Feb-90 |
09-Feb-90 |
09-Feb-90 |
02-Mar-90 |
Amount/plate (mg) |
Revertants/plate Mean and standard deviation in ( ) |
|||
0.03 |
38.0 (± 8.3) |
27.7 (± 2.1) |
93.0 (± 11.5) |
123 (± 6.2) |
0.10 |
34 (± 7.5) |
28.7 (± 9.1) |
103.7 (± 3.1) |
114.3 (± 13.0) |
0.30 |
34.7 (± 4.0) |
24.0 (± 3.5) |
95.7 (± 9.1) |
124.0 (± 13.2) |
1.00 |
36.0 (± 5.3) |
25.7 (± 4.5) |
93.3 (± 7.5) |
110.7 (± 20.0) |
3.00 (T, I) † |
35.0 (± 4.0) |
20.5 (± 3.5) |
0.0 (± 0) |
111.5 (± 4.9) |
Solvent Controls |
33.7 (± 6.8) |
26.0 (± 2.3) |
98.0 (± 10.6) |
123.0 (± 10.4) |
Summary Analysis |
||||
Treatment levels with Rev/Plate > Control |
||||
p<0.06 |
0 |
0 |
0 |
0 |
p<0.01 |
0 |
0 |
0 |
0 |
Bartlett’s test |
N |
N |
N |
N |
No. of outliers (Grubb’s test) |
0 |
0 |
0 |
0 |
Dose Response |
N |
N |
N |
N |
Lack of fit test |
N |
N |
N |
N |
ll analyses performed with Log(10) transformed data.
Codes used are: * = significant at p<=0.06 level; ** = significant at p<=0.01 level; N = Not significant at p<=0.06 level
† = T = Toxicity observed, I = Test material insoluble
Table 3. Statistical summary of plate incorporation test results for TA1535 and TA1537 with and without S9
Strain |
TA1535 |
TA1535 |
TA1537 |
TA1537 |
Activation System |
With S-9 |
None |
With S-9 |
None |
Test Date |
13-Feb-90 |
13-Feb-90 |
13-Feb-90 |
13-Feb-90 |
Amount/plate (mg) |
Revertants/plate Mean and standard deviation in ( ) |
|||
0.03 |
11.7 (± 3.2) |
10.7(± 2.5) |
12.0 (± 1.7) |
9.3 (± 3.1) |
0.10 |
11.0(±1.0) |
9.0 (± 1.0) |
13.3 (± 5.0) |
9.7 (± 6.4) |
0.30 |
10.3(± 1.2) |
8.7 (± 3.1) |
12.3 (± 2.1) |
6.7 (± 1.5) |
1.00 |
11.7(± 3.2) |
11.3 (± 0.6) |
11.0 (± 3.6) |
6.3 (± 0.6) |
3.00 (T, I) † |
12.0 (± 1.0) |
6.0 (± 1.4) |
11.3 (± 1.6) |
7.7 (± 2.1) |
Solvent Controls |
11.9 (± 3.1) |
14.3 (± 1.8) |
9.7 (± 2.6) |
7.2 (± 2.3) |
Summary Analysis |
||||
Treatment levels with Rev/Plate > Control |
||||
p<0.06 |
0 |
0 |
0 |
0 |
p<0.01 |
0 |
0 |
0 |
0 |
Bartlett’s test |
N |
N |
N |
N |
No. of outliers (Grubb’s test) |
0 |
0 |
0 |
0 |
Dose Response |
N |
N |
N |
N |
Lack of fit test |
N |
A |
N |
N |
ll analyses performed with Log(10) transformed data.
Codes used are: * = significant at p<=0.06 level; ** = significant at p<=0.01 level; N = Not significant at p<=0.06 level; A = Data do not allow lack-of-fit test to be performed
† = T = Toxicity observed, I = Test material insoluble
Table 4. Statistical summary of plate incorporation test results for TA98 and TA100 with and without S-9
Strain |
TA98 |
TA98 |
TA100 |
TA100 |
Activation System |
With S-9 |
None |
With S-9 |
None |
Test Date |
23-Feb-90 |
21-Jun-90 |
23-Feb-90 |
23-Feb-90 |
Amount/plate (mg) |
Revertants/plate Mean and standard deviation in ( ) |
|||
0.03 |
40.0 (± 6.8) |
19.0(± 6.6) |
88.3 (± 17.8) |
96.0 (± 22.9) |
0.10 |
35.0(± 6.6) |
17.6 (± 0.7) |
94.0 (± 16.6) |
99.3 (± 22.1) |
0.30 |
36.6(± 7.0) |
18.3 (± 6.8) |
93.7 (± 0.6) |
109.7 (± 12.5) |
1.00 |
37.3(± 7.0) |
14.7 (± 4.2) |
89.7 (± 11.6) |
(T)115.0 (± 18.7) † |
3.00 (T, I) † |
0.0 (± 0.0) |
17.7 (± 0.6) |
0.0 (± 0.0) |
107.3 (± 8.4) |
Solvent Controls |
37.9 (± 0.0) |
17.3 (± 6.3) |
119.4 (± 14.3) |
112.2 (± 20.4) |
Summary Analysis |
||||
Treatment levels with Rev/Plate > Control |
||||
p<0.06 |
0 |
0 |
0 |
0 |
p<0.01 |
0 |
0 |
0 |
0 |
Bartlett’s test |
N |
N |
* |
N |
No. of outliers (Grubb’s test) |
0 |
0 |
A |
0 |
Dose Response |
N |
N |
A |
N |
Lack of fit test |
N |
N |
A |
N |
ll analyses performed with Log(10) transformed data.
Codes used are: * = significant at p<=0.06 level; ** = significant at p<=0.01 level; N = Not significant at p<=0.06 level; A = Data do not allow lack-of-fit test to be performed
† = T = Toxicity observed, I = Test material insoluble
Table 5. Statistical summary of plate incorporation test results for TA1535 and TA1537
Strain |
TA1535 |
TA1535 |
TA1537 |
TA1537 |
Activation System |
With S-9 |
None |
With S-9 |
None |
Test Date |
02-Mar-90 |
02-Mar-90 |
02-Mar-90 |
02-Mar-90 |
Amount/plate (mg) |
Revertants/plate Mean and standard deviation in ( ) |
|||
0.03 |
14.47 (± 1.6) |
16.3(± 1.5) |
11.3 (± 2.1) |
12.0 (± 3.0) |
0.10 |
14.3(± 4.6) |
13.3 (± 4.0) |
10.3 (± 3.2) |
12.3 (± 2.1) |
0.30 |
10.7 (± 1.6) |
14.3 (± 4.2) |
10.3 (± 1.6) |
9.3 (± 3.1) |
1.00 |
16.7(± 3.1)* |
12.7 (± 2.1) |
11.7 (± 1.0) |
8.7 (± 0.0) |
3.00 (T, I) † |
14.0 (± 0.0) |
0.0 (± 0.0) |
0.0 (± 0.0) |
6.0 (± 0.0) |
Solvent Controls |
13.0 (± 2.9) |
16.0 (± 2.7) |
14.7 (± 4.2) |
9.9 (± 2.3) |
Summary Analysis |
||||
Treatment levels with Rev/Plate > Control |
||||
p<0.06 |
1 |
0 |
0 |
0 |
p<0.01 |
0 |
0 |
0 |
0 |
Bartlett’s test |
N |
N |
N |
N |
No. of outliers (Grubb’s test) |
0 |
0 |
0 |
0 |
Dose Response |
N |
N |
N |
N |
Lack of fit test |
N |
N |
N |
N |
ll analyses performed with Log(10) transformed data.
Codes used are: * = significant at p<=0.06 level; ** = significant at p<=0.01 level; N = Not significant at p<=0.06 level
† = T = Toxicity observed, I = Test material insoluble
Applicant's summary and conclusion
- Conclusions:
- The test sample, XP 2563, was concluded not to be mutagenic towards any of the Salmonella typhimurium test strains used (TA98, TA100, TA1535, and TA1537) in the presence or absence of an Aroclor 1254-induced rat liver homogenate metabolic activation system (S-9 Mix)
- Executive summary:
The test material, XP 2563, was tested in Ames/Salmonella plate incorporation assays using test strains TA98, TAlOO, TA1535 and TA1537 in the presence and absence of an Aroclor 1254-induced rat liver homogenate (S-9) . In the toxicity screen, toxicity and insolubility was observed at levels of 3 and 5 mg/plate with and without activation. The maximum dose level for mutagenicity testing was selected to be 3 mg/plate. No significant mutagenicity was observed in both the initial assays and the subsequent confirmation assays. Results therefore suggest that XP 2563 is not a mutagen in Salmonella typhimurium under our experimental conditions.
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