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EC number: 226-798-2 | CAS number: 5470-11-1
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- / AT reversion site not covered, no historical control data provided, no concentrations of positive controls provided, no data on dose-finding study
Data source
Reference
- Reference Type:
- publication
- Title:
- Salmonella Mutagenicity Tests: V. Results from the Testing of 311 Chemicals.
- Author:
- Zeiger E et al.
- Year:
- 1 992
- Bibliographic source:
- Environmental and Molecular Mutagenesis 19 (21): 2 - 141
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- yes
- Remarks:
- / AT reversion site not covered, no historical control data provided, no concentrations of positive controls provided, no data on dose-finding study
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Hydroxylammonium chloride
- EC Number:
- 226-798-2
- EC Name:
- Hydroxylammonium chloride
- Cas Number:
- 5470-11-1
- Molecular formula:
- ClH.H3NO
- IUPAC Name:
- hydroxyammonium chloride
- Test material form:
- solid
Constituent 1
Method
- Target gene:
- his operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male rats and male hamsters, treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- main experiment:
TA 97: 33, 100, 251, 333, 667 µg/plate (- S9 mix, + 10% S9 mix (hamster/rat)); 33, 100, 200, 333, 667 µg/plate (+ 30% S9 mix (hamster/rat))
TA 98: 33, 100, 251, 333, 667 µg/plate (- S9 mix, + 10% S9 mix (10%, hamster/rat)); 33, 100, 333, 1000, 2000 µg/plate (+ 30% S9 mix (hamster/rat))
TA 1535: 33, 100, 200, 333, 667 µg/plate (- S9 mix, + 30% S9 mix (hamster/rat)); 33, 100, 251, 333, 667 µg/plate (+ 10% S9 mix (hamster)); 33, 100, 250, 333, 667 µg/plate (+ 10% S9 mix (rat))
TA 100:
test 1: 10, 33, 100, 333, 667 µg/plate (-S9 mix) ; 100, 333, 500, 750, 1000 µg/plate (+ 10% S9 mix (hamster); 33, 100, 333, 1000, 2000 µg/plate (+ 30% S9 mix (hamster/rat) and + 10% S9 mix (rat))
test 2: 10, 33, 100, 333, 667 µg/plate (-S9 mix) ; 33, 100, 251, 333, 667 µg/plate (+ 10% S9 mix (hamster); 33, 100, 200, 333, 667 µg/plate (+ 10% S9 mix (rat)); 33, 100, 333, 1000, 2000 µg/plate (+ 30% S9 mix (hamster/rat))
test 3: 100, 333, 500, 750, 1000 µg/plate (+ 30% S9 mix (hamster) and + 10% S9 mix (rat)); 33, 100, 200, 333, 667 µg/plate (+ 30% S9 mix (rat))
test 4: 33, 100, 251, 333, 667 µg/plate (+ 30% S9 mix (hamster) + 10% S9 mix (rat)); 100, 333, 500, 750, 1000 µg/plate (+ 30% S9 mix (rat))
test 5: 33, 100, 251, 333, 667 µg/plate (+ 30% S9 (rat)) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenylenediamine (4-NPD), 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: The main assay was carried out in triplicate.
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number his+ colonies and/or clearing of the bacterial background lawn - Rationale for test conditions:
- Reference to "Zeiger E, Drake JW (1980): An environmental mutagenesis test development programme. In Montesano R, Bartsch H, Tomatis L (eds):
“Molecular and Cellular Aspects of Carcinogen Screening Tests." Lyon: IARC Scientific Publications, No. 27, pp 303-313." - Evaluation criteria:
- The test article is judged to be mutagenic or weakly mutagenic, if it produced a reproducible dose-related increase in his+ revertants compared to the corresponding solvent control under a single metabolic activation condition, in replicate trials.
- Statistics:
- Mean values and standard error of means were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- number of revertant colonies decreased to less than half compared to solvent control starting at 333 μg/ plate without S9 mix (52%) and at 667 μg/ plate with 10% S9 mix (hamster, 51%)
- Vehicle controls validity:
- other: no historical control data given
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- other: no historical control data given
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- number of revertant colonies decreased to less than half compared to solvent control starting at 1000 μg/ plate with 30% S9 mix (hamster, 100%)
- Vehicle controls validity:
- other: no historical control data given
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- other: no historical control data given
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- number of revertant colonies decreased to less than half compared to solvent control in exp.1 starting at 750 μg/plate with 10% S9 mix (hamster, 100%) and in exp.1 and 2 at 2000 μg/plate with 30% S9 mix (hamster, 63% and 55% respectively)
- Vehicle controls validity:
- other: no historical control data given
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- other: no historical control data given
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- number of revertant colonies decreased to less than half compared to solvent control starting at 333 μg/plate without S9 mix (59%)
- Vehicle controls validity:
- other: no historical control data given
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- other: no historical control data given
- Remarks on result:
- other: Cytotoxicity was furthermore detected in exp.3 at 1000 μg/plate with 30% S9 mix (hamster, 85%) and starting at 750 μg/plate with 10% S9 mix (rat, 89%), in exp. 4 it started at 750 μg/plate with 30% S9 mix (rat, 85%)
Any other information on results incl. tables
Table 1: Summary of test results (main assay)
With or without S9 -mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
|||||||
Frameshift type |
Base-pair substitution type |
||||||||
TA97 |
TA98 |
TA100 |
TA1535 |
||||||
exp. 1 |
exp. 2 |
exp. 3 |
exp. 4 |
exp. 5 |
|||||
– S9 |
Solvent control (water) |
86 ± 7.8 |
28 ± 4.3 |
118 ± 6.6 |
160 ± 11.3 |
- |
27 ± 2.1 |
||
10 |
- |
103 ± 3.8 |
147 ± 11.6 |
- |
|||||
33 |
105 ± 5.8 |
23 ± 0.0 |
102 ± 5.0 |
138 ± 3.3 |
28 ± 3.2 |
||||
100 |
82 ± 7.4 |
24 ± 2.8 |
100 ± 3.7 |
174 ± 3.1 |
22 ± 3.6 |
||||
200 |
- |
17 ± 2.0 |
|||||||
250 |
- |
||||||||
251 |
64 ± 5.5 |
24 ± 0.3 |
- |
||||||
333 |
41 ± 4.0 s |
20 ± 1.7 |
126 ± 2.6 |
173 ± 4.9 |
11 ± 1.8 |
||||
500 |
- |
- |
- |
- |
- |
||||
667 |
18 ± 1.5 |
21 ± 0.0 |
64 ± 3.2 |
94 ± 10.8 |
9 ± 2.0 |
||||
750 |
- |
- |
|||||||
1000 |
|||||||||
2000 |
|||||||||
Positive controls |
9AA |
4-NPD |
SAZ |
SAZ |
|||||
Mean No. of colonies/plate (average of 3 plates) |
692 ± 11.7 |
582 ± 21.3 |
440 ± 3.1 |
570 ± 42.9 |
- |
257 ± 33.5 |
|||
+ 10% S9 (hamster) |
Solvent control (water) |
208 ± 7.5 |
32 ± 2.6 |
118 ± 7.3 |
124 ± 2.3 |
- |
15 ± 2.4 |
||
10 |
- |
- |
|||||||
33 |
216 ± 6.0 |
29 ± 1.5 |
- |
110 ± 4.2 |
16 ± 1.5 |
||||
100 |
207 ± 6.9 |
26 ± 2.9 |
117 ± 6.4 |
120 ± 1.3 |
14 ± 1.5 |
||||
200 |
- |
- |
|||||||
250 |
|||||||||
251 |
197 ± 5.2 |
26 ± 0.9 |
- |
151 ± 8.4 |
21 ± 1.0 |
||||
333 |
156 ± 1.8 |
25 ± 3.2 |
139 ± 3.3 |
155 ± 0.6 |
19 ± 2.7 |
||||
500 |
- |
62 ± 2.3 |
- |
- |
|||||
667 |
101 ± 11.0 |
29 ± 3.0 |
- |
198 ± 6.1 |
24 ± 0.9 |
||||
750 |
- |
0 ± 0 s |
- |
- |
|||||
1000 |
0 ± 0 s |
||||||||
2000 |
- |
||||||||
Positive control |
2AA |
||||||||
Mean No. of colonies/plate (average of 3 plates) |
646 ± 8.1 |
244 ± 12.5 |
440 ± 12.5 |
383 ± 16.7 |
- |
111 ± 6.7 |
|||
+ 30% S9 (hamster) |
Solvent control (water) |
161 ± 9.4 |
31 ± 0.9 |
123 ± 5.8 |
132 ± 4.8 |
132 ± 5.8 |
176 ± 18.0 |
- |
12 ± 1.3 |
10 |
- |
- |
|||||||
33 |
183 ± 9.0 |
41 ± 1.5 |
126 ± 7.0 |
164 ± 4.1 |
- |
141 ± 5.4 |
17 ± 0.9 |
||
100 |
169 ± 7.4 |
31 ± 2.0 |
100 ± 2.6 |
158 ± 3.5 |
132 ± 1.9 |
115 ± 7.4 |
11 ± 0.9 |
||
200 |
154 ± 23.8 |
- |
- |
13 ± 1.5 |
|||||
250 |
- |
- |
|||||||
251 |
146 ± 9.9 |
||||||||
333 |
138 ± 18.2 |
27 ± 7.6 s |
166 ± 4.6 |
210 ± 3.5 |
216 ± 8.0 |
158 ± 9.5 |
15 ± 0.9 |
||
500 |
- |
- |
201 ± 6.9 |
- |
- |
||||
667 |
105 ± 11.1 |
- |
214 ± 11.9 |
14 ± 2.3 |
|||||
750 |
- |
91 ± 7.1 |
- |
- |
|||||
1000 |
0 ± 0.0 s |
104 ± 7.4 |
130 ± 7.8 s |
20 ± 6.3 s |
|||||
2000 |
t |
45 ± 12.3 s |
60 ± 3.2 s |
- |
|||||
Positive control |
2AA |
||||||||
Mean No. of colonies/plate (average of 3 plates) |
898 ± 51.3 |
171 ± 13.5 |
856 ± 40.5 |
748 ± 11.3 |
578 ± 14.0 |
503 ± 13.5 |
- |
130 ± 7.6 |
|
+ 10% S9 (rat) |
Solvent control (water) |
145 ± 6.0 |
50 ± 2.7 |
126 ± 10.5 |
121 ± 1.8 |
132 ± 4.2 |
136 ± 12.1 |
- |
12 ± 1.5 |
10 |
- |
||||||||
33 |
136 ± 6.2 |
51 ± 4.6 |
128 ± 7.1 |
148 ± 9.2 |
- |
156 ± 6.7 |
- |
15 ± 1.5 |
|
100 |
136 ± 6.6 |
49 ± 2.3 |
169 ± 7.8 |
151 ± 3.6 |
122 ± 4.2 |
162 ± 8.8 |
19 ± 3.0 |
||
200 |
- |
- |
182 ± 4.5 |
- |
- |
- |
|||
250 |
- |
17 ± 4.1 |
|||||||
251 |
159 ± 6.1 |
46 ± 5.5 |
193 ± 13.7 |
- |
|||||
333 |
156 ± 4.0 |
54 ± 5.9 |
188 ± 3.5 |
206 ± 5.9 |
170 ± 7.7 |
195 ± 11.0 |
17 ± 3.1 |
||
500 |
- |
- |
- |
105 ± 3.8 |
- |
- |
|||
667 |
84 ± 2.6 |
55 ± 7.4 |
185 ± 8.5 |
- |
229 ± 13.5 |
15 ± 2.3 |
|||
750 |
- |
- |
14 ± 2.3 |
- |
- |
||||
1000 |
142 ± 9.6 |
0 ± 0.0 s |
|||||||
2000 |
74 ± 3.2 s |
- |
|||||||
Positive control |
2AA |
||||||||
Mean No. of colonies/plate (average of 3 plates) |
1421 ± 8.7 |
118 ± 9.5 |
1215 ± 17.1 |
854 ± 155.7 |
1582 ± 29.0 |
650 ± 64.0 |
- |
302 ± 7.3 |
|
+ 30% S9 (rat) |
Solvent control (water) |
139 ± 19.7 |
34 ± 3.3 |
110 ± 3.0 |
190 ± 4.3 |
161 ± 3.7 |
138 ± 5.7 |
159 ± 3.7 |
13 ± 0.9 |
10 |
- |
||||||||
33 |
130 ± 7.5 |
33 ± 1.9 |
117 ± 6.7 |
187 ± 11.4 |
164 ± 4.3 |
- |
161 ± 4.5 |
12 ± 3.5 |
|
100 |
138 ± 3.5 |
32 ± 0.9 |
130 ± 3.5 |
191 ± 6.0 |
125 ± 5.5 |
143 ± 8.5 |
174 ± 6.2 |
18 ± 1.5 |
|
200 |
96 ± 4.8 |
- |
143 ± 9.0 |
- |
- |
18 ± 0.9 |
|||
250 |
- |
- |
|||||||
251 |
165 ± 1.7 |
||||||||
333 |
99 ± 11.5 |
36 ± 3.2 |
172 ± 4.9 |
184 ± 5.9 |
175 ± 7.0 |
162 ± 5.5 |
178 ± 6.4 |
18 ± 1.2 |
|
500 |
- |
- |
- |
143 ± 2.8 |
- |
- |
|||
667 |
69 ± 4.2 |
173 ± 12.1 |
- |
242 ± 20.5 |
12 ± 2.6 |
||||
750 |
- |
- |
21 ± 0.3 |
- |
|||||
1000 |
28 ± 1.3 |
211 ± 13.3 |
225 ± 18.1 |
0 ± 0.0 s |
|||||
2000 |
18 ± 3.5 s |
66 ± 3.1 s |
86 ± 3.1 s |
- |
|||||
Positive control |
2AA |
||||||||
Mean No. of colonies/plate (average of 3 plates) |
537 ± 34.9 |
499 ± 10.4 |
1536 ± 1.3 |
673 ± 11.6 |
1536 ± 16.6 |
1525 ± 23.7 |
1161 ± 19.9 |
71 ± 10.3 |
2AA = 2-aminoanthracene
4-NPD = 4-nitro-o-phenylenediamine
SAZ = sodium azide
9AA = 9-aminoacridine
s = slight clearing of background lawn
t = complete clearing of background lawn
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.