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EC number: 402-030-3 | CAS number: 624-86-2
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions - E.coli or TA 102 not tested - no data on substance purity
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- (TA 102 or E. Coli was not tested, longer incubation period)
- Principles of method if other than guideline:
- The plate incorporation assay described by Maron and Ames (1983) with minor modifications
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- O-ethylhydroxylamine
- EC Number:
- 402-030-3
- EC Name:
- O-ethylhydroxylamine
- Cas Number:
- 624-86-2
- Molecular formula:
- C2 H7 N O
- IUPAC Name:
- O-ethylhydroxylamine
- Details on test material:
- - Source: Imperial Chemical Industries PLC
- CTL reference number: Y05460/002/001
- Name of test substance as cited in report: Substance H109360
- Identification of test sample as cited in report: 50% (w/v) aqueous solution (45% Substance H109360 and approximately 5% ethanol)
- Appearance: colourless liquid
- Lot #: EFI-100
- Analytical purity: not specified
- Storage: at room temperature
Constituent 1
Method
- Target gene:
- His operon
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 and TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 - induced rat liver S-9 fraction mixed with a series of cofactors.
- Test concentrations with justification for top dose:
- 1.6, 8, 40, 200, 1000, 5000 µg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- (sterility control)
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: (+ S-9): 2-aminoanthracene, 2-AA; (- S-9): Acridine mutagen (ICR191), Daunomycin Hcl (DR), 4-nitro-o-phenylene-diamine (4-NOPD), N-methyl-N'-nitro-N nitrosoguanidine (MNNG)
- Remarks:
- 2-AA (all strains), ICR191 (1537), DR (TA 98), 4-NOPD (TA 1538), MNNG (TA 100 and TA 1535),
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 64-68 hours
NUMBER OF REPLICATIONS: 2 experiments, 3 plates/dose (test substance), 5 plates/dose (negative control), 2 plates/dose (positive and sterility controls)
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- - A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice the colony count of the corresponding solvent control is observed.
- A second criterion for a positive result is the observation of a statistically significant dose-related increase in the number of revertants. In either case, the observed effect should be reproducible. - Statistics:
- An assessment of the statistical significance was carried out using a one-tailed Student's t-test. The corresponding probability for each dose level was determined from a t-table using the appropriate degrees of freedom.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: Salmonella typhimurium TA 98, 100, 1537 and 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- (with and without metabolic activation)
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- (with metabolic activation only)
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No signficant reproducible increases in the number of revertant colonies were present all tester strains in the absence of S9-mix, nor in strains TA 98, TA 100, TA 1537 and TA 1538 in the presence of S9-mix. However, in experiment 1 the test material induced an increase in revertant colony numbers in strain TA 1535 in the presence of S9-mix, reaching a maximum increase at the top dose tested. This response was highly significant, showed some dose-relationship and was reproducible in the second experiment (see table 2). The positive control substance induced expected increase in revertant colonies in the respective strains (see table 1).
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Positive Control Data (Ratio of Test Value to Control value). Control; N= 5, Positive control; N= 2
|
|
[C] µg/plate |
Ratio of Test Value/control value |
|||||||||
TA 1535 |
TA 1537 |
TA 1538 |
TA 98 |
TA 100 |
||||||||
Exp 1 |
Exp 2 |
Exp 1 |
Exp 2 |
Exp 1 |
Exp 2 |
Exp 1 |
Exp 2 |
Exp 1 |
Exp 2 |
|||
+ S9 |
2-AA |
2.0 |
4.4 |
4.5 |
10.1 |
9.0 |
- |
- |
- |
- |
- |
- |
1.0 |
3.4 |
1.8 |
5.4 |
3.9 |
27.4 |
33.9 |
20.0 |
19.6 |
3.4 |
3.9 |
||
0.5 |
1.9 |
1.2 |
2.1 |
3.0 |
15.5 |
14.1 |
7.2 |
10.7 |
2.2 |
3.0 |
||
0.2 |
- |
- |
- |
- |
4.7 |
6.9 |
3.9 |
4.7 |
1.2 |
1.6 |
||
- S9 |
MNNG |
5.0 |
68.3 |
31.2 |
- |
- |
- |
- |
- |
- |
- |
- |
2.0 |
5.8 |
2.5 |
- |
- |
- |
- |
- |
- |
- |
- |
||
1.0 |
1.0 |
0.7 |
- |
- |
- |
- |
- |
- |
- |
- |
||
ICR 191 |
2.0 |
- |
- |
14.6 |
11.3 |
- |
- |
- |
- |
- |
- |
|
1.0 |
- |
- |
6.9 |
10.5 |
- |
- |
- |
- |
- |
- |
||
0.5 |
- |
- |
4.4 |
12.3 |
- |
- |
- |
- |
- |
- |
||
4-NOPD |
5.0 |
- |
- |
- |
- |
48.3 |
43.0 |
- |
- |
- |
- |
|
2.0 |
- |
- |
- |
- |
19.7 |
16.6 |
- |
- |
- |
- |
||
1.0 |
- |
- |
- |
- |
8.1 |
10.6 |
- |
- |
- |
- |
||
DR |
1.0 |
- |
- |
- |
- |
- |
- |
37.8 |
26.8 |
- |
- |
|
0.5 |
- |
- |
- |
- |
- |
- |
22.7 |
17.6 |
- |
- |
||
0.2 |
- |
- |
- |
- |
- |
- |
10.6 |
9.4 |
- |
- |
||
MNNG |
5.0 |
- |
- |
- |
- |
- |
- |
- |
- |
13.7 |
7.7 |
|
2.0 |
- |
- |
- |
- |
- |
- |
- |
- |
1.9 |
1.5 |
||
1.0 |
- |
- |
- |
- |
- |
- |
- |
- |
0.8 |
1.1 |
+ S9: In the presence of metabloic activation; - S9: In the absence of metabloic activatio
2- aminoanthracene: 2 -AA; Acridine mutagen: ICR191; Daunomycin Hcl : DR; 4 -nitro-o-phenylene-diamine: 4 -NOPD; N-methyl-N'-nitro-N nitrosoguanidine: MNNG
Table 2 :Test Data (Ratio of Test Value to Control value). Control; N= 5, Test substance: N= 3
|
[C] µg/plate |
Ratio of |
|||||||||
TA 1535 |
TA 1537 |
TA 1538 |
TA 98 |
TA 100 |
|||||||
Exp 1 |
Exp 2 |
Exp 1 |
Exp 2 |
Exp 1 |
Exp 2 |
Exp 1 |
Exp 2 |
Exp 1 |
Exp 2 |
||
+ S9 |
5000 |
2.1 |
2.2 |
0.2 |
0.4 |
0.5 |
0.4 |
0.6 |
0.4 |
0.9 |
1.1 |
1000 |
1.4 |
1.3 |
0.4 |
0.4 |
0.8 |
1.0 |
0.9 |
0.8 |
0.9 |
1.1 |
|
200 |
1.2 |
1.1 |
0.6 |
0.8 |
0.8 |
1.2 |
1.0 |
1.1 |
1.1 |
1.0 |
|
40 |
1.2 |
0.9 |
1.2 |
0.8 |
1.1 |
0.9 |
1.1 |
1.0 |
1.0 |
1.0 |
|
8.0 |
1.0 |
1.1 |
1.0 |
0.7 |
0.9 |
0.9 |
0.8 |
1.2 |
1.0 |
1.0 |
|
1.6 |
1.2 |
1.0 |
1.1 |
1.0 |
0.3 |
1.1 |
0.8 |
1.0 |
0.9 |
1.0 |
|
|
|||||||||||
- S9 |
5000 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.1 |
0.8 |
0.8 |
1000 |
0.8 |
0.7 |
0.7 |
0.5 |
0.9 |
0.7 |
1.7 |
1.0 |
1.3 |
1.1 |
|
200 |
1.0 |
1.1 |
1.1 |
0.7 |
1.7 |
0.8 |
1.1 |
1.1 |
1.2 |
0.9 |
|
40 |
0.9 |
1.1 |
1.4 |
1.3 |
1.1 |
1.3 |
1.1 |
1.2 |
1.2 |
1.0 |
|
8.0 |
0.8 |
1.0 |
1.1 |
1.0 |
0.9 |
0.8 |
0.9 |
1.0 |
1.2 |
1.0 |
|
1.6 |
1.0 |
0.8 |
1.1 |
0.9 |
0.9 |
1.0 |
1.0 |
1.2 |
1.0 |
1.0 |
+ S9: In the presence of metabloic activation; - S9: In the absence of metabloic activation;
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation
negative without metabolic activation
Since there was no evidence of mutagenicity in S. typhimurium TA 98, 100, 1537 and 1538 with and without metabolic activation as well as with S. typhimurium TA 1535 without metabolic activation but strain TA 1535 revealed a reproducible increase in revertant colony numbers in the presence of metabolic activation induced by Substance H109360, reaching a maximum increase at the top dose tested, the test substance is considered to be mutagenic in vitro under the conditions of this study.
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