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EC number: 204-878-8 | CAS number: 128-09-6
- 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
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:
- 8 April 2004 to 17 January 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his- (s. typhimurium)
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium, other: TA97a
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- 5000, 1667, 556, 185, 62, 21 µg/plate
- Vehicle / solvent:
- DMSO was used as solvent for the test substance and for the negative control group.
- Details on test system and experimental conditions:
- The exposure was performed according to the "Plate Incorporation Assay", in which bacteria, test substance (and microsomes) are in contact on the plate without preceding incubation in liquid state. The number of viable cells in the overnight-cuture is in the range of 200 000 000 cells per mL.
For each sample the following solutions were combined:
• 0.1 mL of the overnight culture of the bacteria,
• 0.5 mL of S9-mix (or phosphate buffered saline for samples without metabolic activation),
• 0.1 mL of the appropriate test- or reference substance solution and
• 2 mL of top agar.
The combined solutions were mixed and spread over a plate with minimal agar (9 cm diameter). After the top agar had solidified, the plates were incubated at 37 °C until the colonies were visible (2 days).
Bacterial strains of S. typhimurium (TA97a, TA98, TA100, TA102 and TA1535) were obtained from Prof. Bruce N. Ames, Berkely, California. The bacteria were stored in small portions in a solutions of 6 % DMSO in PBS in liquid nitrogen.
Counting of colonies: The plates of the strains with a low spontaneous revertant rate, i.e. TA98 and TA1535 were counted visually by marking the colonies with a felt tipped pen. The plates of the other strains were photographed with a video camera and the picture files were scanned for colonies by a computer program.
The results of the first experiment were verified by a second, independent experiment.
Triplicate repetitions were run for each dose group in each of the two separate experiments that were conducted, for the control groups six-fold repetitions were run.
Positive controls:
Strain TA97a: 4-NOPD 10 µg (without S9), DMBA 10 µg (with S9)
Strain TA98: 2-NF 2 µg (without S9), 2-AA 1 µg (with S9)
Strain TA100: Sodium-azide 2 µg (without S9), 2-AA 2ug (with S9)
Strain TA102: t-BHPO 50 µg (without S9), DHA 50 µg (with S9)
Strain TA1535: Sodium-azide 1 µg (without S9), 2-AA 2 µg (with S9) - Evaluation criteria:
- Means and standard deviations were calculated for the number of mutants in every concentration group.
The criteria for a positive result were:
A reproducible increase of the number of revertants to more than the following threshold values for at least one of the concentrations:
• For the strains with a low spontaneous revertant rate i.e. TA98 and TA1535: 250 % of the amount of the spontaneous revertants.
• For the strains with a high spontaneous revertant rate i.e. TA97a, TA100 and TA102: 167 % of the amount of the spontaneous revertants. - Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Toxicity at 5000 µg/plate without metabolisation.
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Toxicity at 5000 µg/plate without metabolisation.
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Toxicity at 5000 µg/plate without metabolisation.
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Toxicity at 5000 µg/plate without metabolisation.
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Toxicity at 5000 µg/plate without metabolisation.
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- PRECIPITATION:
No precipitation of the test substance was seen in any of the concentration groups.
RANGE-FINDING/SCREENING STUDIES:
In a preliminary test the test substance was toxic to the bactera at 5000 µg/plate, resulting in a missing bacterial background lawn. In lower concentrations no toxicity was observed.
COMPARISON WITH HISTORICAL CONTROL DATA:
The numbers of spontaneous revertants were comparable with the historic control data for the negative controls.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the main test the test substance was again toxic to the bacteria at 5000 µg/plate, resulting in a reduced bacterial background in the samples without metabolisation. At 1667 µg/plate and beneath the bacterial background was normal. - Conclusions:
- Interpretation of results (migrated information):
negative in strains TA97a, TA98, TA100, TA102, TA1535
According to the results, "N-Chloro Succinimide" is not mutagenic in the Ames test with the strains of Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 up to 5000 µg per plate which is the limit concentration for this kind of test. - Executive summary:
Method
"N-CHLORO SUCCINIMIDE" was tested for mutagenic activity with the "Salmonella typhimurium Reverse Mutation Test" (Ames Test). The study was conducted in accordance with the OECD-guideline 471 and directive 2000/32/EC, part B.13/14.
The test substance, dissolved in DMSO, was tested at concentrations ranging from 21 µg to5000 µg per plate according to the "direct plate incorporation method" without external metabolisation as well as with an external metabolising system (S9-mix). As test system the bacterial strains Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 were used. Negative and positive controls were included. An independent repetition of the experiment was performed.
Results
Positive controls:
All positive control groups showed significantly increased mutation frequencies which demonstrate the sensitivity of the test system.
Test substance:
Toxicity:
A reduced bacterial background lawn was noted at 5000 µg/plate in the samples without metabolisation.
Solubility:
No precipitation of the test substance was seen in any of the concentration groups.
Mutagenicity:
In none of the concentrations tested and with none of the strains used an increase of the mutation frequency to more than the threshold values (250 % of the controls for strains TA98 and TA1535, 167 % of the controls for strains TA97a, TA100 and TA102) was obtained. Metabolic activation did not change these results.
Conclusion
According to the results obtained in this study, "N-CHLORO SUCCINIMIDE" is non-mutagenic in the Ames test with the strains TA97a, TA98, TA100, TA102 and TA1535 up to 5000 µg/plate, which is the limit concentration for this kind of test.
.
Reference
Positive control substances:
All positive control substances increased the mutation frequency to more than the threshold values.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Short description of key information:
N-CHLORO SUCCINIMIDE is non-mutagenic in the Ames test with the strains TA97a, TA98, TA100, TA102 and TA1535 up to 5000 µg/plate.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
No indications for the need of classification were obtained.
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