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EC number: 204-100-7 | CAS number: 115-69-5
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Sep - 09 Oct 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Basic data given: TA102 or E. coli WP2 are not included in the testing. According to OECD 471, at least five strains of bacteria should be included in the testing. In this Ames test, only four S. typhimurium strains (TA1535, TA1537, TA98, TA100) were used. It is known that these strains have not the potential to detect certain types of mutagens, such as cross-linking agents or oxidising mutagens. In order to detect such mutagens it is required to include S. typhimurium TA102 or to add a DNA repair-proficient strain of E.coli (e.g. E.coli WP2 uvrA or E.coli WP2 uvrA (pKM101)).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- - only 4 strains tested
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- - only 4 strains tested
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-amino-2-methylpropane-1,3-diol
- EC Number:
- 204-100-7
- EC Name:
- 2-amino-2-methylpropane-1,3-diol
- Cas Number:
- 115-69-5
- Molecular formula:
- C4H11NO2
- IUPAC Name:
- 2-amino-2-methylpropane-1,3-diol
- Test material form:
- solid: crystalline
- Details on test material:
- - Analytical purity: no data
- Batch No.: 14840
- Storage condition of test material: At room temperature in the dark.
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Strains are regularly checked for their histidine-requirement, crystal violet sensitivity, UV-sensitivity, ampicillin resistance (TA98 and TA100) and the frequency of spontaneous revertants.
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat livers from adult males (Wistar or Sprague Dawley) intraperitoneally injected with a solution (20% w/v) of Aroclor 1254 (500 mg/kg bw) in corn oil
- Test concentrations with justification for top dose:
- with S9-mix: 100, 300, 1000, 3333, 5000
without S9-mix: 100, 300, 1000, 3333, 5000 - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: milli-Q water (Millipore corp., Bedford, Mass., USA)
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- milli-Q water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: without S9-mix: sodium azide (TA1535, 1 µg in saline), 9-aminoacridine (TA1537, 60 µg in saline, daunomycine (TA98, 2 µg in saline), methylmethanesulfonate (TA100, 650 µg in DMSO)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- milli-Q water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: with S9-mix: 2-aminoanthracene (TA1535, TA1537: 0.5 µg in DMSO; TA98, TA100: 5 µg in DMSO)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 2 experiments with and without S9-mix, each experiment with 3 replicate plates
DETERMINATION OF CYTOTOXICITY
- Method: viability determination - Evaluation criteria:
- When the number of reverse mutation colonies increased by almost twice the solvent control or more, and reproducibilityor dependence on the dose of the test substance was observed, the result was considered 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:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
A preliminary toxicity determination of the test substance in TA100 was done. The percentage survival of the TA100 culture was determined by comparing the number of colonies on the solvent control plate with those on the plates containing the test substance. Based on these data, the AMPD was tested in the main test up to a concentration of 5000 µg/plate in the absence and presence of S9-mix
COMPARISON WITH HISTORICAL CONTROL DATA:
The negative and strain -specific positive control values fell within the laboratory background historical ranges indicating that the test conditions were optimal and that the metabolic activation system functioned properly.
Any other information on results incl. tables
Table 1: Results of the main test
1st experiment |
number of revertants/plate: mean value of vehicle/solvent control ± SD |
number of revertants/plate: mean value of positive control ± SD |
max. number of revertants/plate: mean value of test material ± SD [concentration in experiment (µg/plate) resulting in max. number of revertants/plate] |
without S9-mix |
|||
TA 98 |
17 ± 1 |
1621 ± 85 |
25 ± 1 [100] |
TA 100 |
94 ± 11 |
673 ± 51 |
95 ± 16 [5000] |
TA 1535 |
12 ± 3 |
195 ± 20 |
10 ± 3 [100] |
TA 1537 |
12 ± 3 |
463 ± 35 |
9 ± 3 [100] |
with S9-mix |
|||
TA 98 |
22 ± 2 |
440 ± 26 |
27 ± 5 [3330] |
TA 100 |
85 ± 3 |
725 ± 83 |
95 ± 6 [100] |
TA 1535 |
11 ± 3 |
358 ± 17 |
12 ± 4 [100] |
TA 1537 |
7 ± 1 |
931 ± 59 |
10 ± 4 [3330] |
2nd experiment |
number of revertants/plate: mean value of vehicle/solvent control ± SD |
number of revertants/plate: mean value of positive control ± SD |
max. number of revertants/plate: mean value of test material ± SD [concentration in experiment (µg/plate) resulting in max. number of revertants/plate] |
without S9-mix |
|||
TA 98 |
30 ± 3 |
1033 ± 83 |
46 ± 4 [1000] |
TA 100 |
127 ± 16 |
883 ± 15 |
152 ± 17 [3330] |
TA 1535 |
20 ± 2 |
210 ± 45 |
18 ± 8 [1000] |
TA 1537 |
8 ± 2 |
273 ± 55 |
8 ± 3 [5000] |
with S9-mix |
|||
TA 98 |
36 ± 5 |
904 ± 5 |
42 ± 4 [333] |
TA 100 |
121 ± 4 |
1059 ± 73 |
139 ± 14 [100] |
TA 1535 |
15 ± 5 |
203 ± 22 |
14 ± 3 [333] |
TA 1537 |
6 ± 1 |
748 ± 23 |
9 ± 4 [333] |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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