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EC number: 226-546-1 | CAS number: 5422-34-4
- 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
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:
- 03 - 16 Aug 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, UK
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-2-hydroxyethyllactamide
- EC Number:
- 226-546-1
- EC Name:
- N-2-hydroxyethyllactamide
- Cas Number:
- 5422-34-4
- Molecular formula:
- C5H11NO3
- IUPAC Name:
- N-2-hydroxyethyllactamide
Constituent 1
Method
- Target gene:
- his/trp operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: University of California, Berkely, USA; British Industrial Biological Research Association, UK - Additional strain / cell type characteristics:
- other: All TA strains carry a mutation of the uvr B gene coding for the DNA excision repair system (uvr B) and the deep rough mutation (rfa), TA 100 and TA 98 contain the R-factor plasmid (pkM101). E.coli contains an uvr A DNA repair deficiency
- Metabolic activation:
- with and without
- Metabolic activation system:
- co-factor supplemented post-mitochondrial fraction (10% S9-mix), prepared from the livers of rats treated with phenobarbital/ β-naphtolflavone
- Test concentrations with justification for top dose:
- Experiment I:
- 1.5, 5, 15, 50, 150, 500, 1500 and 500 µg/plate (with and without metabolic activation)
Experiment II:
- 15, 50, 150, 500, 1500 and 500 µg/plate (with and without metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: sterile distilled water
- Justification for choice of solvent/vehicle: The test item was fully miscible in sterile distilled water at 50 mg/mL in solubility checks performed in-house. Sterile distilled water was therefore selected as the vehicle.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9-mix: N-ethyl-N´-nitro-N-nitrosoguanidine (ENNG), 9-Aminoacridine (9AA), 4-Nitroquinoline-1-oxide (4NQO); +S9-mix: 2-Aminoanthracene (2AA), Benzo(a)pyrene (BP)
- Remarks:
- ENNG: 2, 3, 5 μg/plate (E. coli, TA 100, TA 1535); 9AA: 80 μg/plate (TA 1537); 4NQO: 0.2 μg/plate (TA 98); 2AA: 1, 2, 10 μg/plate (TA 100, TA 1535 + TA 1537, E.coli); BP: 5 μg/plate (TA 98)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:; in agar (plate incorporation); pre-incubation
DURATION
- Pre-incubation period: 20 min (pre-incubation test)
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicate cultures for each test concentration, negative (untreated), vehicle and positive control
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Rationale for test conditions:
- The test item was tested under the experimental test conditions recommended in the appropriate OECD guideline 471.
- Evaluation criteria:
- There are several criteria for determining a positive result. Any, one, or all of the following can be used to determine the overall result of the study: a dose-related increase in mutant frequency over the dose range tested; a reproducible increase at one or more concentrations; biological relevance against in-house historical control ranges; statistical analysis of data as determined by UKEMS; fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response). A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met. Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit making a definite judgment about test item activity. Results of this type will be reported as equivocal.
- Statistics:
- Statistical significance was confirmed by using Dunnetts Regression Analysis (* = p <0.05) for those values that indicate statistically significant increases in the frequency of revertant colonies compared to the concurrent solvent control.
Results and discussion
Test results
- Key result
- Species / strain:
- other: 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation was observed in any experiment either in the presence or absence of metabolic activation.
HISTORICAL CONTROL DATA
- Positive historical control data: The results were within the range of historical control data.
- Negative/solvent historical control data: The results were within the range of historical control data.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- No cytotoxicity was observed in any experiment either in the presence or absence of metabolic activation.
Any other information on results incl. tables
Table 1: Test results - Experiment I
With or without S9-mix |
Test substance concentration (µg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA 1535 |
E. coli WP2 |
TA 98 |
TA 1537 |
||
- |
Solvent |
68 ± 4.6 |
11 ± 2.5 |
15 ± 1.2 |
22 ± 3.0 |
14 ± 6.7 |
- |
1.5 |
74 ± 7.6 |
12 ± 3.5 |
15 ± 5.1 |
23 ± 6.1 |
9 ± 1.2 |
- |
5 |
76 ± 14.2 |
13 ± 1.5 |
12 ± 0.6 |
19 ± 2.5 |
12 ± 2.5 |
- |
15 |
67 ± 8.3 |
12 ± 4.0 |
17 ± 5.5 |
20 ± 6.7 |
15 ± 2.3 |
- |
50 |
64 ± 5.8 |
12 ± 1.5 |
19 ± 6.7 |
22 ± 3.1 |
12 ± 7.5 |
- |
150 |
65 ± 2.3 |
14 ± 3.5 |
15 ± 4.6 |
25 ± 6.7 |
13 ± 6.0 |
- |
500 |
70 ± 4.2 |
10 ± 4.0 |
11 ± 3.8 |
23 ± 1.2 |
6 ± 2.3 |
- |
1500 |
66 ± 4.7 |
12 ± 3.5 |
14 ± 1.0 |
20 ± 3.6 |
9 ± 4.6 |
- |
5000 |
72 ± 11.9 |
11 ± 3.0 |
14 ± 7.4 |
22 ± 4.0 |
9 ± 4.9 |
|
Name |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
Concentration (µg/plate) |
3 |
5 |
2 |
0.2 |
80 |
|
Mean No. of colonies/plate (average of 3 plates ± SD) |
319 ± 31.6 |
306 ± 99.1 |
525 ± 23.6 |
225 ± 9.3 |
226 ± 46.5 |
|
+ |
Solvent |
72 ± 6.4 |
12 ± 2.6 |
26 ± 2.3 |
22 ± 5.5 |
13 ± 0.6 |
+ |
1.5 |
74 ± 9.6 |
9 ± 1.7 |
25 ± 10.5 |
28 ± 3.1 |
11 ± 2.9 |
+ |
5 |
76 ± 0.0 |
9 ± 1.2 |
20 ± 7.4 |
17 ± 1.7 |
19 ± 4.2 |
+ |
15 |
82 ± 12.7 |
9 ± 1.5 |
17 ± 2.1 |
29 ± 4.7 |
18 ± 5.2 |
+ |
50 |
77 ± 4.2 |
12 ± 3.2 |
23 ± 5.5 |
30 ± 4.7 |
13 ± 3.0 |
+ |
150 |
72 ± 3.5 |
11 ± 3.2 |
28 ± 2.1 |
21 ± 4.6 |
14 ± 0.6 |
+ |
500 |
66 ± 3.1 |
10 ± 0.6 |
18 ± 3.2 |
20 ± 4.5 |
11 ± 4.0 |
+ |
1500 |
70 ± 11.9 |
11 ± 1.7 |
23 ± 4.4 |
22 ± 2.6 |
10 ± 3.5 |
+ |
5000 |
65 ± 4.4 |
7 ± 1.0 |
18 ± 4.9 |
18 ± 0.6 |
12 ± 7.8 |
|
Name |
2AA |
2AA |
2AA |
BP |
2AA |
Concentration (µg/plate) |
1 |
2 |
10 |
5 |
2 |
|
Mean No. of colonies/plate (average of 3 plates ± SD) |
1176 ± 45.1 |
137 ± 10.3 |
461 ± 27.5 |
114 ± 1.5 |
243 ± 32.1 |
ENNG: N-ethyl-N´-nitro-N-nitrosoguanidine
9AA: 9-Aminoacridine
4NQO: 4-Nitroquinoline-1-oxide
2AA: 2-Aminoanthracene
BP: Benzo(a)pyrene
Table 2: Test results - Experiment II
With or without S9-mix |
Test substance concentration (µg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA 1535 |
E. coli WP2 |
TA 98 |
TA 1537 |
||
- |
Solvent |
90 ± 3.2 |
15 ± 4.9 |
30 ± 14.0 |
30 ± 3.5 |
14 ± 3.0 |
- |
15 |
91 ± 1.5 |
20 ± 5.0 |
23 ± 4.9 |
29 ± 2.5 |
19 ± 6.6 |
- |
50 |
77 ± 2.5 |
22 ± 3.1 |
24 ± 5.1 |
27 ± 11.4 |
15 ± 1.0 |
- |
150 |
90 ± 3.5 |
18 ± 7.9 |
23 ± 7.1 |
33 ± 3.6 |
19 ± 4.0 |
- |
500 |
99 ± 7.8 |
15 ± 2.1 |
18 ± 5.0 |
33 ± 6.0 |
20 ± 7.0 |
- |
1500 |
98 ± 10.7 |
14 ± 3.2 |
15 ± 5.8 |
26 ± 4.5 |
16 ± 1.0 |
- |
5000 |
79 ± 10.4 |
10 ± 3.1 |
23 ± 1.7 |
25 ± 2.5 |
18 ± 5.2 |
|
Name |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
Concentration (µg/plate) |
3 |
5 |
2 |
0.2 |
80 |
|
Mean No. of colonies/plate (average of 3 plates ± SD) |
654 ± 73.5 |
1661 ± 349.5 |
1003 ± 60.6 |
272 ± 14.2 |
618 ± 292.7 |
|
+ |
Solvent |
84 ± 10.8 |
22 ± 6.2 |
23 ± 3.8 |
28 ± 11.5 |
15 ± 4.6 |
+ |
15 |
94 ± 7.6 |
22 ± 2.6 |
30 ± 6.7 |
35 ± 9.1 |
20 ± 3.5 |
+ |
50 |
93 ± 8.5 |
24 ± 4.7 |
27 ± 5.1 |
31 ± 8.9 |
16 ± 3.5 |
+ |
150 |
102 ± 6.1 |
17 ± 11.5 |
24 ± 3.0 |
28 ± 5.3 |
14 ± 2.1 |
+ |
500 |
98 ± 8.7 |
15 ± 4.0 |
26 ± 1.2 |
24 ± 4.9 |
19 ± 2.1 |
+ |
1500 |
101 ± 12.5 |
16 ± 6.1 |
28 ± 2.5 |
22 ± 3.1 |
12 ± 5.2 |
+ |
5000 |
90 ± 3.0 |
21 ± 9.5 |
26 ± 4.9 |
30 ± 9.0 |
18 ± 0.6 |
|
Name |
2AA |
2AA |
2AA |
BP |
2AA |
Concentration (µg/plate) |
1 |
2 |
10 |
5 |
2 |
|
Mean No. of colonies/plate (average of 3 plates ± SD) |
964 ± 71.8 |
241 ± 14.5 |
193 ± 7.8 |
146 ± 51.1 |
268 ± 9.0 |
ENNG: N-ethyl-N´-nitro-N-nitrosoguanidine
9AA: 9-Aminoacridine
4NQO: 4-Nitroquinoline-1-oxide
2AA: 2-Aminoanthracene
BP: Benzo(a)pyrene
Applicant's summary and conclusion
- Conclusions:
- The test material was considered to be non-mutagenic under the conditions of this test.
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