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Registration Dossier
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EC number: 250-437-8 | CAS number: 31024-56-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation (Bacterial reverse mutation assay / Ames test): S. typhimurium TA 1535, TA 1537, TA 98, TA 100, and TA 1538: negative with and without metabolic activation (similar to OECD TG 471)
Gene mutation (Bacterial reverse mutation assay / Ames test, RA from CAS 277085-51-0 and CAS 120939-52-8): TA 1535, TA 1537, TA 98, TA 100, and TA 102: negative with and without metabolic activation (according to OECD TG 471)
Mammalian cytogenicity (CHO chromosome aberration assay, RA from CAS 157923-74-5): negative with and without metabolic activation (according to OECD TG 473)
Mammalian Mutagenicity (HPRT Test, RA from CAS 36957-84-3): negative with and without metabolic activation (similar to OECD TG 476)
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- yes
- Remarks:
- (no strain was included for detection of oxidising or cross-linking substances)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his operon
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- 0.05, 0.1, 0.5, 1 and 5 mg/plate
- Vehicle / solvent:
- - Solvent: ethanol
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- ethylmethanesulphonate
- methylmethanesulfonate
- other: 2-aminoanthracene (+S9, all strains: 0.002 mg/plate)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Cytotoxicity was determined in a preliminary study using strain TA 98 and also within the main study cytotoxicity was determined. No further information was given about the method applied. - Evaluation criteria:
- No significant effects: number of colonies after treatment with test substance is less than 2-fold the number of colonies of the solvent control.
Significant effects: number of colonies after treatment with test substance is at least 2-fold the number of colonies of the solvent control. - Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- -S9: 5 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- -S9: 1 and 5 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- -S9: 5 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- -S9: 1 and 5 mg/plate; +S9: 5 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- -S9: 1 and 5 mg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
In a preliminary study the test substance was applied to bacteria (TA 98) from 0.5 to 100 mg/plate. Cytotoxicity was observed from 5 mg/plate upwards. - Conclusions:
- Interpretation of results: negative
In a bacterial mutagenicity assay similar to OECD 471 and GLP, no mutagenic effect was observed for the test substance tested up to the top dose of 5000 µg/plate in any of the test strains in two independent experiments without and with metabolic activation. The test substance is non-mutagenic under the applied conditions. - Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- see attached document for justification of read-across
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- 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:
- Interpretation of results: negative
One study is available from the structural analogue 4-amino-3,3-dimethylbutyltrimethoxysilane (CAS 157923-74-5). In this study it was observed that the source substance does not induce chromosomal aberration in mammalian cells. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in the genetic toxicity potential that are higher than the typical experimental error of the test method. - Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- see attached document for justification of read-across
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- reduced cloning efficiency at 2 mg/ml in 1 experiment (decrease of 20%)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results: negative
One study is available from the structural analogue 2-(triethoxysilyl)propylamine (CAS 36957-84-3). In this study it was observed that the source substance does not induce chromosomal aberration in mammalian cells. As explained in the justification for type of information, the differences in molecular structure between the target and the source are unlikely to lead to differences in the genetic toxicity potential that are higher than the typical experimental error of the test method. - Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Source CAS 120939-52-8
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxic effects at 2.5 µL/plate and higher, ±S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Source CAS 120939-52-8
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxic effects at 1.0 µL/plate and higher, ±S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Remarks:
- Source CAS 120939-52-8
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxic effects at 2.5 µL/plate and higher, ±S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Source CAS 120939-52-8
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxic effects at 2.5 µL/plate and higher, ±S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Source CAS 120939-52-8
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxic effects at 5.0 µL/plate, ±S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Source CAS 227085-51-0
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. I: at 5000 µg/plate without S9-mix; Exp. II: ≥2500 µg/plate without S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Source CAS 227085-51-0
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in Exp. II: ≥2500 µg/plate without S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Source CAS 227085-51-0
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. I: at 5000 µg/plate without S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Source CAS 227085-51-0
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. I: at 5000 µg/plate without S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Remarks:
- Source CAS 227085-51-0
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Exp. I: at 5000 µg/plate without S9-mix; Exp. II: ≥2500 µg/plate without S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- In the available Ames tests from the structural analogues N-ethyl-3-trimethoxysilyl-2-methyl-propanamine (CAS 227085-51-0) and N-{3-[dimethoxy(methyl)silyl]propyl}butan-1-amine (CAS 120939-52-8) no mutategenic effects were observed in the S. typhimurium strains TA98, TA 100, TA 1535, TA 1537 and TA 102 with and without metabolic activation up to the limit dose of 5000 µg/plate. Thus, N-[3-(trimethoxysilyl)propyl]-1-butanamine (CAS 31024-56-3) is considered non-mutagenic bacteria including the 5th strain for detection of oxidising or cross-linking substances.
Referenceopen allclose all
Table 1: Test results of experiment 1.
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate |
|||||
(μg/plate) |
(average of 3 plates ± Standard deviation) |
||||||
|
|
|
|||||
|
TA 98 |
TA 100 |
TA1535 |
TA1537 |
TA1538 |
||
– |
0 |
28±4 |
83±4 |
9±3 |
5±1 |
22±1 |
|
– |
50 |
25±1 |
91±5 |
9±4 |
4±1 |
26±1 |
|
– |
100 |
26±8 |
90±11 |
6±2 |
5±0 |
23±4 |
|
– |
500 |
21±5 |
101±9 |
7±0 |
6±2 |
19±5 |
|
– |
1000 |
21±2 |
78±6 |
11±4 |
8±5 |
26±4 |
|
– |
5000 |
T |
53±8 |
5±1 |
T |
5±2 |
|
Positive controls, –S9 |
Name |
2-NF |
MMS |
EMS |
9-AA |
2-NF |
|
Concentrations (μg/plate) |
1 |
100 |
10000 |
50 |
1 |
||
Mean No. of colonies/plate (average of 3) |
472 |
299 |
1035 |
131 |
248 |
||
+ |
0 |
39±4 |
112±12 |
13±5 |
5±2 |
34±9 |
|
+ |
50 |
35±5 |
107±2 |
8±2 |
7±4 |
40±4 |
|
+ |
100 |
36±5 |
107±20 |
8±2 |
5±2 |
35±13 |
|
+ |
500 |
37±1 |
108±6 |
12±3 |
7±2 |
33±3 |
|
+ |
1000 |
34±7 |
102±8 |
10±3 |
4 |
33±8 |
|
+ |
5000 |
36±3 |
111±4 |
9±4 |
4±2 |
38±7 |
|
Positive controls, +S9 |
Name |
2-A |
2-A |
2-A |
2-A |
2-A |
|
Concentrations (μg/plate) |
2 |
2 |
2 |
2 |
2 |
||
Mean No. of colonies/plate (average of 3) |
554 |
1528 |
239 |
63 |
298 |
||
Table 2: Test results of experiment 2.
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate |
|||||
(μg/plate) |
(average of 3 plates ± Standard deviation) |
||||||
|
|
|
|||||
|
TA 98 |
TA 100 |
TA1535 |
TA1537 |
TA1538 |
||
– |
0 |
28±5 |
78±7 |
7±2 |
6±2 |
32±6 |
|
– |
50 |
28±3 |
81±16 |
7±3 |
5±2 |
32±4 |
|
– |
100 |
29±2 |
73±17 |
7±3 |
4±1 |
30±3 |
|
– |
500 |
27±6 |
73±8 |
7±3 |
5±1 |
25±3 |
|
– |
1000 |
28±6 |
T |
5±3 |
2±1 |
7±6 |
|
– |
5000 |
T |
T |
7±1 |
T |
T |
|
Positive controls, –S9 |
Name |
2-NF |
MMS |
EMS |
9-AA |
2-NF |
|
Concentrations (μg/plate) |
1 |
100 |
10000 |
50 |
1 |
||
Mean No. of colonies/plate (average of 3) |
573 |
270 |
835 |
116 |
548 |
||
+ |
0 |
43±10 |
118±4 |
9±5 |
6±1 |
38±3 |
|
+ |
50 |
41±5 |
107±13 |
11±2 |
5±3 |
47±11 |
|
+ |
100 |
43±2 |
101±14 |
8±2 |
5±1 |
38±10 |
|
+ |
500 |
44±14 |
101±11 |
9±5 |
5±3 |
42±9 |
|
+ |
1000 |
46±11 |
98±17 |
9±1 |
6±2 |
49±4 |
|
+ |
5000 |
43±8 |
109±5 |
11±2 |
6±1 |
41±12 |
|
Positive controls, +S9 |
Name |
2-A |
2-A |
2-A |
2-A |
2-A |
|
Concentrations (μg/plate) |
2 |
2 |
2 |
2 |
2 |
||
Mean No. of colonies/plate (average of 3) |
673 |
1337 |
185 |
35 |
579 |
||
MMS = methyl methanesulfonate
EMS = ethyl methanesulfonate
9AA = 9-aminoacridine
2-A = 2-aminoanthracene
T = cytotoxic
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A bacterial mutagenicity study with N-[3-(trimethoxysilyl)propyl]-1-butanamine (CAS 31024-56-3) is available. However, it lacks the strain for detecting cross-linking or oxidising mutagens ("5th strain", e.g. TA 102 or E. coli WP2). Therefore read-across from the structurally related source substances N-ethyl-3-trimethoxysilyl-2-methylpropanamine (CAS 227085-51-0) and N-{3-[Dimethoxy(methyl)silyl]propyl}butan-1-amine (CAS 120939-52-8) was applied.
No further information is available for the registered substance, however, reliable data are available for the closely related substances, 4-amino-3,3-dimethylbutyltrimethoxysilane (CAS 157923-74-5) and 2-(triethoxysilyl)propylamine (CAS 36957-84-3) on cytogenicity and mutagenicity in mammalian cells, respectively. In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and following the Read across assessment framework (RAAF, ECHA 2017) read across from an analogue substance has been applied to support the human health hazard assessment of N-[3-(trimethoxysilyl)propyl]butylamine (CAS 31024-56-3). Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.
Discussion of results:
In vitro genotoxicity
Ames test
A bacterial gene mutation study (Ames test) with N-[3-(trimethoxysilyl)propyl]-1-butanamine (CAS 31024-56-3) was performed comparable to OECD 471 and in compliance with GLP (Hazleton France, 1989). No test-substance related increase in the number of revertants was observed when tested in two independent experiments with and without metabolic activation up to the top concentration of 5000 µg/plate in Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98, and TA 100 in the plate incorporation assay. Cytotoxicity in the absence of metabolic activation was noted at 1000 and 5000 µg/plate for strains TA 1538, TA 100 and TA 1537 and at 5000 µg/plate for strains TA 1538 and TA 98. In the presence of metabolic activation cytotoxic effects occurred at 5000 µg/plate in strain TA 1537. Appropriate solvent and positive controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
A bacterial gene mutation study (Ames test) with N-ethyl-3-trimethoxysilyl-2-methylpropanamine (CAS 227085-51-0) was performed according to OECD 471 and in compliance with GLP (RCC, 2001). The Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 were tested in concentrations from 33 to 5000 µg/plate according to the plate incorporation (experiment I) and pre-incubation (experiment II) procedure in the absence and presence of a metabolic activation system. Relevant toxic effects occurred in all strains except TA 100 in the first experiment at 5000 µg/plate without metabolic activation. In the second experiment substantial toxic effects were observed in strains TA 98, TA 100 and TA 102 at 2500 and 5000 µg/plate without metabolic activation. Appropriate solvent (DMSO) and positive controls were included and gave the expected results. No significant increase in the number of revertants was observed in any of the tester strains with and without metabolic activation. Therefore, the test material was considered to be non-mutagenic under the conditions of the test.
In the Ames assay with N-{3-[dimethoxy(methyl)silyl]propyl}butan-1-amine (CAS 120939-52-8) conducted according to OECD 471 and GLP compliant, the plate incorporation test (experiment I) and the pre-incubation test (experiment II) were performed using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA102 with and without metabolic activation (Eurofins, 2018). The following concentrations of the test item were used in the experiments: 0.0100, 0.0316, 0.100, 0.316, 1.0, 2.5 and 5.0 µL/plate for experiment I; and 0.00316, 0.0100, 0.0316, 0.100, 0.316, 1.0, 2.5 and 5.0 µL/plate for experiment II.
No precipitation of the test item was observed in any tester strain used in experiments I and II (with and without metabolic activation). Cytotoxicity was observed in both experiments. In experiment I, toxic effects of the test item were observed at concentrations of 2.5 µL/plate and higher, -S9, and at a concentration of 5.0 µl/plate, +S9, depending on the particular tester strain. In experiment II, toxic effects of the test item were noted at concentrations of 1.0 µL/plate and higher, -S9, and at concentrations of 2.5 µL/plate and higher, +S9, depending on the particular tester strain.
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed at any concentration level, neither in the presence nor absence of metabolic activation in experiments I and II. Therefore,N-{3-[dimethoxy(methyl)silyl]propyl}butan-1-amine is considered to be non-mutagenic in this bacterial reverse mutation assay.
Cytogenicity in mammalian cells
In the available key study (RCC, 2001) 4-amino-3,3-dimethylbutyltrimethoxysilane (CAS 157923-74-5) was tested for cytogenicity according to the OECD TG 473, and in compliance with GLP. The test substance did not induce structural chromosomal aberrations in the Chinese hamster lung fibroblasts (V79) cell line with and without metabolic activation up to limit concentrations. Appropriate solvent and positive controls were included in the test and gave the expected results. It is concluded that 4-amino-3,3-dimethylbutyltrimethoxysilane (CAS 157923-74-5) is negative for the induction of chromosome aberrations under the conditions of the test.
Gene mutation in mammalian cells
In the available key study (Bushy Run Research Center, 1985) 2-(triethoxysilyl)propylamine (CAS 36957-84-3) was tested for mammalian mutagenicity (HPRT Test) similar to the OECD TG 476, and in compliance with GLP. No increase in mutant frequency was observed at any concentration up to cytotoxicity with and without metabolic activation at 5 hour of treatment. Expected results were obtained with positive, solvent, and negative controls. It is concluded that 2-(triethoxysilyl)propylamine (CAS 36957-84-3) is negative for the induction of mutations in Chinese hamster Ovary cells (CHO) under the conditions of the test.
In vivo genotoxicty
No data available.
Justification for classification or non-classification
The available data on genetic toxicity do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.
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