Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 227-572-6 | CAS number: 5892-47-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The mutagenicity of the registration substance was investigated using Bacteria Reverse Mutation Assay (Ames test) according to the Guideline OECD 471. No mutagenicity was found.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 liver homogenated, induced by phenobarbital and ß-naphtholflavone
- Test concentrations with justification for top dose:
- up to the highest dose of 5000 µg/plate
- Vehicle / solvent:
- DMSO was used as vehicle.
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: Sodium azide for TA 100 and TA 1535 without S9; Methyl methane sulfonate for WP2uvrA without S9; 4-Nitro-o-phenylene-diamine for TA 98 and TA 1535 without S9; 2-Aminoanthracene for all strains with S9.
- Details on test system and experimental conditions:
- Exp I: plate incorporation method
Exp II: pre-incubation method - Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium TA 100
- 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
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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
- Conclusions:
- The mutagenicity of the registration substance was investigated using Bacteria Reverse Mutation Assay (Ames test) according to the Guideline OECD 471. No mutagenicity was found.
- Executive summary:
The mutagenicity of the registration substance was investigated using Bacteria Reverse Mutation Assay (Ames test) according to the Guideline OECD 471. Up to the highest concentration of 5000 µg/plate, no mutagenicity was found.
Reference
Experiment: 1 (plate incorporation method) |
|||||||||||||
S9-Mix (-) |
Dose Level Per Plate |
Number of Revertants, (Mean) |
|||||||||||
Base-pair Substitution Strains |
Frameshift Strains |
||||||||||||
TA 100 |
TA 1535 |
WP2 uvrA |
TA 98 |
TA 1537 |
|||||||||
Untreated Control |
97 97 100 |
(98) |
13 7 27 |
(16) |
53 50 56 |
(53) |
26 14 32 |
(24) |
20 21 23 |
(21) |
|||
Solvent Control (DMSO) |
108 110 108 |
(109) |
10 11 18 |
(13) |
53 39 53 |
(48) |
31 23 19 |
(24) |
18 24 19 |
(20) |
|||
31.6 µg |
116 125 108 |
(116) |
8 13 14 |
(12) |
36 46 43 |
(42) |
24 23 24 |
(24) |
19 15 22 |
(19) |
|||
100 µg |
115 100 107 |
(107) |
11 6 12 |
(10) |
46 41 29 |
(39) |
22 20 19 |
(20) |
26 24 15 |
(22) |
|||
316 µg |
103 121 115 |
(113) |
13 14 9 |
(12) |
52 53 45 |
(50) |
27 16 20 |
(21) |
16 18 19 |
(18) |
|||
1000 µg |
109 96 81 |
(95) |
16 13 9 |
(13) |
43 48 41 |
(44) |
20 20 16 |
(19) |
20 18 19 |
(19) |
|||
2500 µg |
87 P 100 P 120 P |
(102) |
9 P 10 P 7 P |
(9) |
64 P 37 P 45 P |
(49) |
25 P 19 P 19 P |
(21) |
17 P 16 P 18 P |
(17) |
|||
5000 µg |
109 P 117 P 126 P |
(117) |
11 P 8 P 10 P |
(10) |
53 P 52 P 62 P |
(56) |
20 P 24 P 24 P |
(23) |
21 P 16 P 17 P |
(18) |
|||
S9-Mix (-) |
Name Dose Level No. of Revertants |
NaN3 |
NaN3 |
MMS |
4-NOPD |
4-NOPD |
|||||||
10 µg |
10 µg |
1.0 µL |
10 µg |
40 µg |
|||||||||
511 508 466 |
(495) |
1227 1194 1034 |
(1152) |
1049 875 872 |
(932) |
240 263 261 |
(255) |
74 72 70 |
(72) |
||||
P: Precipitation
NaN3 MMS 4-NOPD |
sodium azide methyl methane sulfonate 4-nitro-o-phenylene-diamine |
Experiment: 1 (plate incorporation method) |
||||||||||||||
S9-Mix (+) |
Dose Level Per Plate |
Number of Revertants, (Mean) |
|
|||||||||||
Base-pair Substitution Strains |
Frameshift Strains |
|
||||||||||||
TA 100 |
TA 1535 |
WP2 uvrA |
TA 98 |
TA 1537 |
|
|||||||||
Untreated Control |
115 105 96 |
(105) |
8 11 11 |
(10) |
68 74 63 |
(68) |
19 18 33 |
(23) |
12 16 15 |
(14) |
|
|||
Solvent Control (DMSO) |
93 88 87 |
(89) |
13 11 17 |
(14) |
53 62 46 |
(54) |
34 24 27 |
(28) |
18 19 19 |
(19) |
|
|||
31.6 µg |
103 118 108 |
(110) |
10 16 10 |
(12) |
48 66 74 |
(63) |
39 24 27 |
(30) |
19 22 23 |
(21) |
|
|||
100 µg |
79 62 87 |
(76) |
9 15 12 |
(12) |
66 50 48 |
(55) |
27 23 22 |
(24) |
18 17 15 |
(17) |
|
|||
316 µg |
101 81 100 |
(94) |
10 16 10 |
(12) |
63 55 54 |
(57) |
30 23 35 |
(29) |
16 15 17 |
(16) |
|
|||
1000 µg |
90 93 78 |
(87) |
12 2 11 |
(8) |
50 54 50 |
(51) |
28 29 27 |
(28) |
19 18 22 |
(20) |
|
|||
2500 µg |
98 P 66 P 108 P |
(91) |
10 P 13 P 10 P |
(11) |
58 P 53 P 51 P |
(54) |
28 P 18 P 22 P |
(23) |
18 P 17 P 16 P |
(17) |
|
|||
5000 µg |
87 P 97 P 97 P |
(94) |
11 P 12 P 10 P |
(11) |
48 P 38 P 37 P |
(41) |
24 P 27 P 35 P |
(29) |
15 P 17 P 16 P |
(16) |
|
|||
S9-Mix (+) |
Name Dose Level No. of Revertants |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
|
|||||||
2.5 µg |
2.5 µg |
10 µg |
2.5 µg |
2.5 µg |
|
|||||||||
618 816 783 |
(739) |
164 187 216 |
(189) |
208 188 194 |
(197) |
2736 2261 2517 |
(2505) |
261 185 256 |
(234) |
|
||||
P: Precipitation
2 -AA: Aminoanthracene
Experiment: 2 (pre-incubation method) |
|||||||||||||
S9-Mix (-) |
Dose Level Per Plate |
Number of Revertants, (Mean) |
|||||||||||
Base-pair Substitution Strains |
Frameshift Strains |
||||||||||||
TA 100 |
TA 1535 |
WP2 uvrA |
TA 98 |
TA 1537 |
|||||||||
Untreated Control |
84 121 122 |
(109) |
25 26 25 |
(25) |
49 44 61 |
(51) |
35 39 34 |
(36) |
20 21 23 |
(21) |
|||
Solvent Control (DMSO) |
116 94 99 |
(103) |
20 22 21 |
(21) |
38 47 37 |
(41) |
36 27 33 |
(32) |
24 26 27 |
(26) |
|||
10.0 µg |
90 101 87 |
(93) |
25 22 23 |
(23) |
44 45 61 |
(50) |
31 23 20 |
(25) |
26 24 23 |
(24) |
|||
31.6 µg |
83 104 93 |
(93) |
24 20 25 |
(23) |
54 43 53 |
(50) |
27 29 36 |
(31) |
22 28 29 |
(26) |
|||
100 µg |
86 113 86 |
(95) |
27 29 22 |
(26) |
52 46 50 |
(49) |
27 36 22 |
(28) |
25 27 24 |
(25) |
|||
316 µg |
78 75 95 |
(83) |
23 24 20 |
(22) |
53 41 66 |
(53) |
39 33 38 |
(37) |
24 28 29 |
(27) |
|||
1000 µg |
128 84 118 |
(110) |
24 24 30 |
(26) |
40 32 49 |
(40) |
28 28 34 |
(30) |
20 25 27 |
(24) |
|||
2500 µg |
120 P 115 P 119 P |
(118) |
31 P 28 P 23 P |
(27) |
40 P 42 P 41 P |
(41) |
28 P 25 P 33 P |
(29) |
26 P 24 P 23 P |
(24) |
|||
5000 µg |
76 P 119 P 95 P |
(97) |
25 P 24 P 23 P |
(24) |
43 P 43 P 53 P |
(46) |
22 P 34 P 35 P |
(30) |
24 P 26 P 24 P |
(25) |
|||
S9-Mix (-) |
Name Dose Level No. of Revertants |
NaN3 |
NaN3 |
MMS |
4-NOPD |
4-NOPD |
|||||||
10 µg |
10 µg |
1.0 µL |
10 µg |
40 µg |
|||||||||
837 787 731 |
(785) |
1031 1084 1137 |
(1084) |
451 452 434 |
(446) |
159 191 187 |
(179) |
203 244 219 |
(222) |
||||
P: Precipitation
NaN3 MMS 4-NOPD |
sodium azide methyl methane sulfonate 4-nitro-o-phenylene-diamine |
Experiment: 2 (pre-incubation method) |
Date Plated: 12 December 2017 |
||||||||||||
|
Date Counted: 19 December 2017 |
||||||||||||
S9-Mix (+) |
Dose Level Per Plate |
Number of Revertants, (Mean) |
|||||||||||
Base-pair Substitution Strains |
Frameshift Strains |
||||||||||||
TA 100 |
TA 1535 |
WP2 uvrA |
TA 98 |
TA 1537 |
|||||||||
Untreated Control |
115 94 107 |
(105) |
20 21 24 |
(22) |
48 48 43 |
(46) |
28 31 25 |
(28) |
25 26 27 |
(26) |
|||
Solvent Control (DMSO) |
93 93 103 |
(96) |
21 22 23 |
(22) |
44 50 41 |
(45) |
20 25 25 |
(23) |
28 24 26 |
(26) |
|||
10.0 µg |
78 100 102 |
(93) |
20 23 21 |
(21) |
49 52 65 |
(55) |
26 20 20 |
(22) |
27 26 25 |
(26) |
|||
31.6 µg |
122 108 111 |
(114) |
24 24 26 |
(25) |
52 56 52 |
(53) |
28 20 28 |
(25) |
24 21 26 |
(24) |
|||
100 µg |
77 77 99 |
(84) |
27 21 20 |
(23) |
49 48 50 |
(49) |
27 20 31 |
(26) |
28 25 24 |
(26) |
|||
316 µg |
73 74 74 |
(74) |
26 27 29 |
(27) |
56 59 59 |
(58) |
25 31 26 |
(27) |
24 29 24 |
(26) |
|||
1000 µg |
77 93 94 |
(88) |
30 25 24 |
(26) |
64 43 59 |
(55) |
31 27 31 |
(30) |
24 26 27 |
(26) |
|||
2500 µg |
71 P 70 P 70 P |
(70) |
30 P 20 P 24 P |
(25) |
50P 59P 44P |
(51) |
27 P 27 P 23 P |
(26) |
20 P 22 P 21 P |
(21) |
|||
5000 µg |
101 P 64 P 96 P |
(87) |
21 P 32 P 28 P |
(27) |
48P 49P 49P |
(49) |
37 P 27 P 24 P |
(29) |
23 P 24 P 24 P |
(24) |
|||
S9-Mix (+) |
Name Dose Level No. of Revertants |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
|||||||
2.5 µg |
2.5 µg |
10 µg |
2.5 µg |
2.5 µg |
|||||||||
2332 2159 2077 |
(2189) |
226 227 233 |
(229) |
118 121 121 |
(120) |
1498 1707 2035 |
(1747) |
259 279 264 |
(267) |
||||
P: Precipitation
2 -AA: Aminoanthracene
Additional information
Justification for classification or non-classification
The mutagenicity of the registration substance was investigated using Bacteria Reverse Mutation Assay (Ames test) according to the Guideline OECD 471. No mutagenicity was found, which supports no classification.
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.
