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EC number: 203-783-9 | CAS number: 110-61-2
- 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
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:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Succinonitrile
- EC Number:
- 203-783-9
- EC Name:
- Succinonitrile
- Cas Number:
- 110-61-2
- Molecular formula:
- C4H4N2
- IUPAC Name:
- butanedinitrile
- Details on test material:
- - Analytical purity: 97%
- Source: Aldrich Chemical Company, Milwaukee, WI, USA
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: DSM Engineering Plastics B.V. lotnumber SN0620140520
- Expiration date of the lot/batch: 2016.07.01
- Purity test date: 99.93%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Store in a cool area (IO-20°C). Containers that have been opened must be filled with dry nitrogen for at least 1min and then sealed. Be careful not to import any water or impurities during the filling and sealing course.
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: Easily soluble in cold water
FORM AS APPLIED IN THE TEST white waxy solid
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells:Molecular Toxicology Inc. US - Additional strain / cell type characteristics:
- other: histidine deficient
- Metabolic activation:
- with and without
- Metabolic activation system:
- system(89 mix)
- Test concentrations with justification for top dose:
- 5000, 1500, 500, 150, 50 and 15 pg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:ultrapure water (H20)
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- other: Dexon (CAS-no. 140-56-7
- Remarks:
- Used in the tester strains TA97a, TA98 and TA102 in the absence of SQ mix (89-).
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Used in the tester strains TA100 and TA1535 in 89-.
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminofluorene (2-AF)
- Evaluation criteria:
- CRITERIA OF POSITIVE RESULT
1) When there is a concentration-related increase over the range (two times greater than the corresponding solvent control in TA97a, TA98, TA100, TA102 and three times greater than the corresponding solvent control in TA1535) in the mean number of revertant colonies in at least one strain with or without metabolic activation system, the test item should be evaluated as positive.
2) When there is a reproducible increase (two times greater than the corresponding solvent control in TA97a, TA98, TA100, TA102 and three times
greater than the corresponding solvent control in TA1535) at one or more concentrations in the mean number of revertant colonies in at least one strain
with or without metabolic activation system, the test item should be evaluated as positive.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: The test item was non-toxic to all the tester strains and soluble at the concentration of 50mg/ml in H20, so H20 was used as solvent, and six dose levels of 5000, 1500, 500, 150, 50 and 15 micro g/plate were set in the first test.
Any other information on results incl. tables
METABOLIC ACTIVATION SYSTEM
In this study, Aroclor 1254 induced rat liver 89 prepared in-house was used as
the metabolic activation system.
PREPARATION OF CULTURE MEDIAAND SOLUTIONS
PREPARATION OF POSITIVE CONTROLS
THE PRELIMINARY TEST
In the test, according to the solubility of the test item. H20 was used as solvent. The standard plate incorporation method was performed at four dose levels, including 5000, 1667.556 and 185ug/plate, in five tester strains of TA97a, TA98, TA100, TA102 and TA1535, with and without metabolic activation system. The dose volumes of each dose group and solvent control group were 0.1 ml/plate, in duplicate.
The results showed that there was no test item precipitate at all doses before and after the incubation.
Dose selection
The test item was non-toxic to all the tester strains and soluble at the concentration of 50mg/ml in H20, so H20 was used as solvent, and six dose levels of 5000, 1500, 500, 150, 50 and 15 microg/plate were set in the first test.
Enrichment culture
One day before the plate-incorporation, the stored tester strains were thawed and cultivated in nutrient broth medium for approximately 16 hours at 36.8~37.1°C.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, the results both in the first test and the validation test were negative. Thus, the test item, Succinonitrile is considered
to be non-mutagenic in the bacterial reverse mutation assay using Salmonella
typhimurium tester strains. - Executive summary:
Introduction. The study was performed to evaluate the ability of Succinonitrile to induce reverse mutations in the genome of the Salmonella typhimurium tester strains with and without the metabolic activation
system(89 mix), and the method was designed to be compatible with the
OECD Guideline for the Testing of Chemicals No.471 “Bacterial Reverse Mutation Test" (July 21, 1997).
Method. Five histidine deficient (his-) mutant tester strains of Salmonella typhimurlum including TA97a, TA98, TA100, TA102 and TA1535 were treated with Succinonitrile using the standard plate incorporation method
and the preincubation method at six dose levels, in triplicate, with positive and solvent controls, both in the presence and absence of the cofactor—supplemented 89 (89 mix).
Based on the results of the preliminary test (initial toxicity test) that had been performed in this lab before, six dose levels in the first test were selected including 5000, 1500, 500, 150, 50 and 15 pg/plate, and sterile ultrapure water (H20) was used as solvent. Then the validation test was conducted using the same dose levels and solvent as the first test.
Results. In the first test, the results of the viable count showed that the density of the cultures for each tester strain was within 0.9~9>< 109 colony forming units (CFU)/m| and was considered acceptable. At the same time,
all results of positive and solvent controls met the requirements of this test, so the sensitivity of the assay and the efficacy of the 89 mix were validated.
In the first test, no test item precipitation was observed on the the surface of GM agar at each dose level before and after the incubation. In addition, no cytotoxicity was detected at any dose level in all tester strains.
In the first test, the mean number of the revertant colonies for any tester strain with any dose of test item, either with or without SQ‘mix, was less than two times (three times for TA1535) of the mean number in the
corresponding solvent control. In the validation test the same results were obtained as in the first test.
Conclusion. Under the conditions of this study, the results both in the first test and the validation test were negative. Thus, the test item, Succinonitrile is considered to be non-mutagenic in the bacterial reverse
mutation assay using Salmonella typhimurium tester strains.
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