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EC number: 947-663-0 | 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
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- Flash point
- Auto flammability
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- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
- Stability
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- Environmental data
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- 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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
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- Genetic toxicity
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- 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:
- 23 April 1991 to 28 May 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Ames et al. (1975)
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diacid 1550
- IUPAC Name:
- Diacid 1550
- Details on test material:
- - Name of test material (as cited in study report): Diacid 1550
- Physical state: Liquid
- Lot/batch No.: Confidential
Constituent 1
Method
- Target gene:
- His-gene (HisG 46, HisC 3076, HisD 3052)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- mammalian liver S9
- Test concentrations with justification for top dose:
- 2.5 and 8 µL of a 10 mg/L solution
2.5, 8, and 25 µL of a 100 mg/L - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylsulfoxide
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- other: 2-anthramine, N-methyl-N-nitro-N-nitrosoguanidine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: not applicable
- Exposure duration: 48 ±4 hours
SELECTION AGENT (mutation assays): Agar containing Histidine
NUMBER OF REPLICATIONS: experiments performed in triplicate
NUMBER OF CELLS EVALUATED: no data available
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (number of revertant colonies per plate) in TA100 - Evaluation criteria:
- The average number of revertant colonies (± the standard deviation) per plate is tabulated. A positive reponse is indicated if a sample substance produces a consistent bacterial response which is two times that of the solvent or spontaneous reversions for TA 98 and TA 100. For the strains TA 15335, TA 1537 and TA 1538, a sample producing a consistent bacterial reponse three times that of the solvent or spontaneous control is indicated as positive.
- Statistics:
- No information available
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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
- Remarks:
- 100 mg/mL induced cytotoxicity in TA 100
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: sample was not soluble above 100 mg/mL in dimethylsulfoxide
RANGE-FINDING/SCREENING STUDIES: Sample was diluted in dimethylsulfoxide and tested for cytoxicity in TA 100; 100 mg/mL induced cytotoxicity - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Average test results per strain ± standard deviation with activation:
Tester Strain |
Solvent control |
Positive control |
10 mg/mL |
100 mg/mL |
|||
2.5 µL |
8 µL |
2.5 µL |
8 µl |
25 µl |
|||
TA 98 |
28±2 |
3842±935 |
28±5 |
23±6 |
28±6 |
30±8 |
28±6 |
TA 100 |
88±3 |
2894±176 |
82±12 |
75±15 |
56±9 |
61±16 |
53±13 |
TA 1535 |
13±1 |
589±200 |
14±2 |
8±3 |
8±2 |
11±6 |
11±3 |
TA 1537 |
15±2 |
135±32 |
14±4 |
19±0 |
31±5 |
14±6 |
2±1 |
TA 1538 |
28±3 |
461±254 |
24±3 |
16±5 |
24±3 |
20±5 |
41±25 |
Average test results per strain ± standard deviation without activation:
Tester Strain |
Solvent control |
Positive control |
10 mg/mL |
100 mg/mL |
|||
2.5 µL |
8 µL |
2.5 µL |
8 µl |
25 µl |
|||
TA 98 |
14±5 |
1443±93 |
10±3 |
16±3 |
11±4 |
11±4 |
11±5 |
TA 100 |
43±2 |
2764±79 |
33±7 |
29±4 |
32±10 |
32±10 |
27±6 |
TA 1535 |
32±4 |
1386±33 |
26±6 |
20±3 |
4±3 |
5±2 |
8±5 |
TA 1537 |
38±16 |
1973±606 |
42±7 |
19±6 |
10±3 |
4±2 |
3±2 |
TA 1538 |
28±20 |
1024±213 |
6±1 |
4±2 |
4±2 |
2±2 |
2±1 |
Applicant's summary and conclusion
- Conclusions:
- In this Ames test, Diacid 1550 did not show any mutagenic activity in the Salmonella Typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 with and without activitation under the conditions of this test.
- Executive summary:
In this study the ability of Diacid 1550 to induce mutations in the Salmonella Typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 was investigated. The study procedures used in this study were based on the Ames Test as described by Ames et al. (1975).
The samples were diluted in dimethylsulfoxide and were incubated on agar plates for 48 ±4 hours at 37 °C (plate incorporation assay). After incubation, the agar plates were examined for the average number of revertant colonies. Prior to the Ames test, a cytoxicity test was performed in TA100 restulting in a cytoxic dose of 100 mg/mL.
Diacid 1550 dit not show any mutagenic activity up to limit concentrations in the Salmonella Typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 with and without activitation under the conditions of this test.
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