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EC number: 259-839-8 | CAS number: 55819-71-1
- 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 Jan - 06 Feb 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, non-GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH S2A,B
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- This study was not performed for REACH purposes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- DL-serinohydrazide monohydrochloride
- EC Number:
- 259-839-8
- EC Name:
- DL-serinohydrazide monohydrochloride
- Cas Number:
- 55819-71-1
- Molecular formula:
- C3H9N3O2.ClH
- IUPAC Name:
- 2-amino-3-hydroxy-propanehydrazide;hydrochloride
- Details on test material:
- - Molecular weight: 155.5850
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA1535, TA97, TA98, TA100, TA102
- Additional strain / cell type characteristics:
- other: all strains except TA102 are deficient in excision repair (uvrB mutation); TA97, TA98, TA100, TA102 contain pKM101 plasmid for error prone DNA repair system; TA102 reverting gene on multicopy plasmid pAQ1 (a pBR322 derivative)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix, Moltox post mitochondrial supernatant
- Test concentrations with justification for top dose:
- 50, 158, 500, 1580, 5000 µg/plate with and without S9-mix
- Vehicle / solvent:
- solvent for test item: deionised water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: ICR 191; 2-Aminoanthracene (2-AA)
- Remarks:
- -S9 mix: Sodium azide in DMSO (TA1535, TA100) and ICR 191 (TA97): 1.0 µg/plate; -S9 mix: MMC in aqua dest. (TA102): 0.2 µg/plate; -S9 mix: 2-Nitrofluorene in DMSO (TA98): 0.5 µg/plate; +S9 mix: 2-AA in DMSO (all strains): 4.0 and 10.0 (for TA102) µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS:
- Three replicate plates for the test item and negative control
- two replicate plates for the positive controls
DETERMINATION OF CYTOTOXICITY
- Method: determination of the growth of the background lawn and/or frequency of spontaneous revertants - Evaluation criteria:
- A positive result is often defined as a reproducible, dose-related increase in the number of his+ revertants reaching at least a doubling of the number of spontaneous revertants for Salmonella typhimurium strains TA1535 and TA98 or a 1.5 - fold increase for strains TA97, TA100 and TA102. Other investigators have set higher limits for a mutagenic response (factor 3 and 2 for the respective groups of strains).
A negative result is defined as the absence of a reproducible increase in the number of his+ revertant colonies.
A positive response in one strain, under one treatment condition, will usually be sufficient to call a test item mutagenic. However, concordant results under variable conditions and/or in several strains usually carry more weight than singular findings. Strong increases (in absolute terms or as fold-increase) and increases at low concentrations are also usually considered to be more relevant than weak increases at high concentrations although it has to be noted that there is no quantitative relationship between mutagenic potency in the Ames tests and carcinogenic potency in mammals.
The described rules of thumb have a questionable scientific foundation and biological relevance should always be taken into account. Since the shape of the dose response curve, toxicity, precipitation, and the observed plate to plate variability of the counts may all influence the final call, it is impossible to predefine unequivocal criteria for positive or negative responses which would apply to every configuration of the data generated by the mutation assay.
The study director is ultimately responsible for the final assessment. - Statistics:
- There is no generally accepted statistical treatment of Ames test data.
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA1535, TA97, TA98, TA100, TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: the test item was soluble in deionised water
- Precipitation: no precipitation observed up to the maximal dose
RANGE-FINDING/SCREENING STUDIES:
- range finder assay with strain TA100 (plate incorporation version, +S9) was performed
- no precipitation and no toxic effects observed
COMPARISON WITH HISTORICAL CONTROL DATA:
- mutant frequencies of the controls were in the range of historical control values and the data published in literature
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- no cytotoxic effects were apparent up to the maximal dose - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The test item induces dose related increases in the number of revertant colonies in several strains. The effect was most obvious in strain TA1535 (-S9), was also apparent in strains TA1535 (+S9), TA97 (+/-S9) and TA100 (-S9). For strain TA98 the plates with S9 were not evaluable but a repeat with this strain was not considered necessary as it would not change the test outcome.
Table 1 Summary Data of Results of Plate Incorporation Assay
Summary Data: Plate Incorporation Assay
|
|||||
S9-Mix |
Without
|
||||
Test item (µg/plate) |
TA 1535 |
TA 97 |
TA 98 |
TA 100 |
TA 102 |
Solvent Control (deionised water) |
16 ± 2 |
295 ± 20 |
20 ± 9 |
98 ± 8 |
521 ± 57 |
Test item (50) |
24 ± 7 |
323 ± 43 |
17 ± 1 |
102 ± 3 |
492 ± 7 |
Test item (158) |
27 ± 8 |
329 ± 34 |
21 ± 8 |
97 ± 14 |
502 ± 46 |
Test item (500) |
56 ± 9 |
383 ± 38 |
27 ± 5 |
105 ± 15 |
430 ± 29 |
Test item (1580) |
116 ± 13 |
405 ± 32 |
27 ± 5 |
169 ± 26 |
454 ±24 |
Test item (5000) |
161 ± 20 |
581 ± 37 |
23 ± 4 |
182 ± 18 |
487 ± 30 |
Na azide (1.0) |
856 ±15 |
|
|
688 ± 69 |
|
ICR 191 (1.0) |
|
1605 ± 601 |
|
|
|
2-NF (0.5) |
|
|
93 ± 7 |
|
|
MMC (0.2) |
|
|
|
|
1151 ± 54 |
S9-Mix |
With
|
||||
Test item (µg/plate) |
TA 1535 |
TA 97 |
TA 98 |
TA 100 |
TA 102 |
Solvent Control (deionised water) |
11 ± 5 |
439 ± 23 |
e |
118 ± 4 |
314 ± 188 |
Test item (50) |
14 ± 4 |
423 ± 36 |
e |
124 ± 12 |
425 ± 32 |
Test item (158) |
12 ± 5c |
441 ± 36 |
e |
115 ± 7 |
436 ± 34 |
Test item (500) |
14 ± 6 |
476 ± 0c |
e |
125 ± 1 |
378 ± 50 |
Test item (1580) |
26 ± 4 |
531 ± 11 |
e |
123 ± 2 |
356 ± 7 |
Test item (5000) |
39 ± 6 |
663 ± 62 |
e |
145 ± 14 |
265 ± 42 |
2-AA (4.0) |
234 ± 24 |
984 ± 108 |
e |
496 ± 40 |
|
2-AA (10.0) |
|
|
e |
|
3043 ± 23 |
Viability
|
|||||
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
187 ± 11 |
178 ± 28 |
45 ± 7 |
149 ± 34 |
136 ± 49 |
|
Key to Positive Controls Na azide: Sodium Azide 2-AA: 2-Aminoanthracen MMC: Mitomycin C ICR 19: ICR 191 2NF: 2-Nitrofluorene |
Key to Plate Postfix Codes c: contaminated plate e: plate not evaluable (colonies not countable) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
The test item induced weak but dose related increases of the number of revertant colonies in three of the five tester strains. The effect was most apparent in strain TA1535 but also recognizable in strains TA97 and TA100.
Thus, it has to be concluded that the test item possesses a weak mutagenic activity in the Ames test under the described experimental conditions with and without metabolic activiation. - Executive summary:
The test item was evaluated for mutagenic activity in the Ames test. The test was performed in accordance with the OECD Guideline 471 for the Testing of Chemicals (Bacterial Reverse Mutation Test, Adopted 21st July 1997). A standard plate incorporation assay was performed in absence and in presence of an exogenous metabolic activation system (S9). Five Salmonella typhimurium tester strains (TA1535, TA97, TA98, TA100, and TA102) were employed. The activity of the S9-mix and the responsiveness of the tester strains were verified by including appropriate controls into each experiment.
The test item was dissolved in deionised water. Concentrations ranging from 50 to 5000 µg/plate were selected for evaluation including
the generally recommended highest test concentration for non toxic compounds. No toxicity was observed in this dose range.
The test item induced weak but dose related increases of the number of revertant colonies in three of the five tester strains. The effect was most apparent in strain TA1535 but also recognizable in strains TA97 and TA100.
Thus, it has to be concluded that the test item possesses a weak mutagenic activity in the Ames test under the described experimental conditions with and without metabolic activation.
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