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EC number: 206-764-3 | CAS number: 373-44-4
- 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
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Genetic toxicity: in vitro
Administrative data
- 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:
- 1997-05-13 - 1997-07-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Remarks:
- BASF AG, Department of Toxicology, Ludwigshafen/Rhein
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Octamethylenediamine
- EC Number:
- 206-764-3
- EC Name:
- Octamethylenediamine
- Cas Number:
- 373-44-4
- Molecular formula:
- C8H20N2
- IUPAC Name:
- octane-1,8-diamine
- Details on test material:
- - Name of test material (as cited in study report): 1,8-Oktamethylendiamin
- Physical state: white solidified melt
- Storage condition of test material: room temperature
- Test substance number: 96/668
- Analytical purity: 99.9 area % (GC)
- Lot/batch No.: 66-0280
- Date of manufacture: December 1994
Constituent 1
Method
- Target gene:
- histidine (his-) and tryptophan (trp-)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian liver post-mitochondrial fraction (S-9) was prepared from 5 male Sprague-Dawley rats with a single intraperitoneal injection of Aroclor 1254 according to Ames et.al.
- Test concentrations with justification for top dose:
- Standard plate test (SPT): 0, 20, 100, 500, 2500 and 5000 µg/plate
Preincubation test (PIT): 0, 4, 20, 100, 500 and 1500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Water
- Justification for choice of solvent/vehicle: Water was chosen due to the good solubility of the test substance
Controls
- Untreated negative controls:
- yes
- Remarks:
- Sterility control (soft agar, S9-mix, buffer, vehicle/test substance, but without test strains)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Vehicle control
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- different for with and without metabolic activation test strains
- Positive control substance:
- other: With S-9 mix: 2-aminoanthracene (2-AA) / Without S-9 mix: TA 1535, TA 100: N-methyl-N´-nitro-N-nitrosoguanidine (MNNG); TA 98: 4-nitro-o-phenylendiamine (NOPD); TA 1537: 9-aminoacridine (AAC); E.coli WP2 uvrA: N-ethyl-N´-nitro-N-nitrosoquanidine (ENNG)
- Details on test system and experimental conditions:
- SALMONELLA TYPHIMURIUM
The experimental procedure of the standard plate test (plate incorporation method) is based on the method of Ames et. al. The experimental procedure of the standard plate test (plate incorporation method) is based on the Test tubes containing 2-mL portions of soft agar (overlay agar), which consists of 100 mL agar (0.6 % agar + 0.6 % NaCl) and 10 mL amino acid solution (minimal amino acid solution for the determination of mutants : 0 .5 mM histidine + 0 .5 mM biotin) are kept in a water bath at 45 °C, and the remaining components are added in the following order :
0.1 mL test solution or vehicle
0.1 mL fresh bacterial culture
0.5 mL S-9 mix (in tests with metabolic activation) or 0 .5 mL phosphate buffer (in tests without metabolic activation)
After mixing, the samples are poured onto Vogel-Bonner agar plates (minimal glucose agar plates) within approx . 30 seconds. Composition of the minimal glucose agar :
980 mL aqua dest .
20 mL Vogel-Bonner E medium
15 g Difco bacto aga r
20 g D-glucose, monohydrate .
ESCHERICHIA COLI
The experimental procedure is based on the method of Ames et. al. Test tubes containing 2-mL portions of soft agar (overlay agar), which consists of 100 mLagar (0.6 % agar + 0.6 % NaCl) and 10 mL amino acid solution (minimal amino acid solution for the determination of mutants : 0.5 mM tryptophan) are kept in a water bath at 45 °C, and the remaining components are added in the following order :
0.1 mL test solution or vehicle
0.1 mL fresh bacterial culture
0.5 mL S-9 mix (in tests with metabolic activation) or 0.5 mL phosphate buffer (in tests without metabolic activation)
After mixing, the samples are poured onto minimal agar plates within approx. 30 seconds.
Composition of the minimal agar: The composition of the minimal agar (SA1 selective agar) is based on the description of Green, M.H.L. and Muriel, W.J., with the exception of solution E (tryptophan solution), which has previously been added to the soft agar:
300 mL solution B (agar )
100 mL solution A(saline solution)
8 mL solution C (glucose solution)
10 mL solution D(casein solution )
DURATION
- Exposure duration: the plates incubated at 37 °C in the dark for at 48 - 72 h - Evaluation criteria:
- ACCEPTANCE CRITERIA
Generally, the experiment is to be considered valid if the following criteria are met:
- The number of revertant colonies in the negative controls was within the normal range of the historical control data for each tester strain.
- The sterility controls revealed no indication of bacterial contamination.
- The positive control articles both with and without S-9 mix induced a significant increase in the number of revertant colonies within the range of the historical control data.
- The titer of viable bacteria was >= 10^9/mL.
EVALUATION CRITERIA
- The test chemical is considered positive in this assay if the following criteria are met: A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.
- A test substance is generally considered nonmutagenic in this test if: The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other. - Statistics:
- No details available.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: A bacteriotoxic effect was observed under all test conditions.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TOXICITY
A bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants, reduction in the titer) was observed in the standard plate test from about 2,500 μg/plate onward. In the preincubation assay bacteriotoxicity was observed depending on the strain and test conditions from about 100 μg - 500 μg/plate onward.
SOLUBILITY
No test substance precipitation was found. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: Standard Plate Test and Precincubation Test
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
The study is considered as valid OECD Guideline 471 and 472 study without deviations and was performed under certificated Good Laboratory Praxis (GLP) and therefore considered to be of the highest quality (reliability Klimisch 1). The test material did not induce an increases in the frequency of revertant colonies in any of the bacterial strains, therefore the test material can be considered as non-mutagenic under these test conditions. - Executive summary:
The test substance octamethylenediamine was investigated according to OECD TG471 and 472 for its potential to cause gene mutation in Salmonella typhimurium strains (TA98, TA100, TA1537, TA1535 and TA1538) and Escherichia coli WP2 uvrA (Engelhardt and Hoffmann, 1999). The Standard plate test (SPT) was performed with test concentrations of 20 - 5000 µg/plate and concentrations of 4 - 1500 µg/plate were used in the Preincubation test (PIT). Due to the good water solubility of the substance, auqa dest. was used as vehicle. The test was performed with and without a metabolic activation system. For this purpose, the mammalian liver post-mitochondrial fraction (S-9) was prepared from 5 male Sprague-Dawley rats with a single intraperitoneal injection of Aroclor 1254 according to Ames et.al. A bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants, reduction in the titer) was observed in the standard plate test from about 2,500 μg/plate onward. In the preincubation assay bacteriotoxicity was observed depending on the strain and test conditions from about 100 μg - 500 μg/plate onward. Up to the highest investigated dose, no relevant increase of the revertant colony numbers was obtained in any Salmonella typhimurium strain as well as in the E.coli strain in comparison with the corresponding controls. In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test material caused neither base-pair substitutions, nor frameshift mutations. Therefore these test results revealed no indication of gene mutagenic activity.
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