Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 240-385-4 | CAS number: 16294-75-0
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: current guideline study according to GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- autosomal thymidine kinase (TK) locus
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/b-Naphthoflavone induced rat liver S9 was used as the metabolic activation system. The S9 was prepared from 8 - 12 weeks old male Wistar HanIbm rats.
- Test concentrations with justification for top dose:
- Experiment I
without S9 mix: 11.3; 22.5; 45.0; 90.0 and 180.0 μg/mL
with S9 mix: 11.3; 22.5; 45.0; 90.0 and 180.0 μg/mL
Experiment II
without S9 mix: 11.3; 22.5; 45.0; 90.0 and 180.0 μg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO;
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium;
DURATION
- Exposure duration:4 (with S9) or 24 hours (without S9)
- Expression time (cells in growth medium): 72 h; 48 h in the second experiment
- Selection time (if incubation with a selection agent): 10 - 15 days
SELECTION AGENT (mutation assays): TFT (trifluorothymidine)
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth, cloning effieciency - Statistics:
- A mutation assay is considered acceptable if it meets the following criteria:
a) Both plates, from either the survival or the TFT resistance-testing portion of the experiment are analysable.
b) The absolute cloning efficiency 2 of the negative and/or solvent controls is > 0.5 (50 %).
c) The spontaneous mutant frequency in the negative and/or solvent controls are in the range of our historical control data.
d) The positive controls (MMS and CPA) induce significant (at least 2-fold) increases in the mutant frequencies. The values of the cloning efficiencies and the relative total growth are greater than 10 % of the concurrent vehicle control group. - Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results (migrated information):
negative
The test material is considered to be non-mutagenic in this mouse lymphoma
assay. - Executive summary:
The study was performed to investigate the potential of the test material to induce mutations at the mouse lymphoma thymidine kinase locus using the cell line L5178Y.
The assay was performed in two independent experiments, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 h. The second experiment was solely performed in the absence of metabolic activation with a treatment period of 24 hours.
The highest applied concentration (180 μg/mL) was limited by the solubility properties of the test item.
No substantial and reproducible dose dependent increase in mutant colony numbers was observed in both main experiments. No relevant shift of the ratio of small versus large colonies was observed up to the maximal concentration of the test item.
Appropriate reference mutagens were used as positive controls and showed a distinct increase in induced mutant colonies, indicating that the tests were sensitive and valid.
The tested concentrations were:
Experiment I
without S9 mix: 11.3; 22.5; 45.0; 90.0 and 180.0 μg/mL
with S9 mix: 11.3; 22.5; 45.0; 90.0 and 180.0 μg/mL
Experiment II
without S9 mix: 11.3; 22.5; 45.0; 90.0 and 180.0 μg/mL
The evaluated experimental points and the results are summarised in table:
Culture 1
Culture 2
µg/mL
S9
Rel cloning effic.
Rel. total growth
Mutant colonies /106cells
Induction factor
Rel cloning effic.
Rel. total growth
Mutant colonies /106cells
Induction factor
Experiment 1
Medium control
0
-
100.0
100.0
49
100.0
100.0
79
Solvent Control
0
-
100
100
54
1,0
100
100
42
1,0
MMS
19,5
-
50,0
17,5
672
13,6
33,3
23,0
716
9,0
Test item
5,7
-
73,6
discontinued
116,1
discontinued
Test item
11,3
-
100
73,4
136
2,5
105,5
132,2
22
0,5
Test item
22,5
-
71,1
120,0
39
0,7
83,5
86,8
28
0,7
Test item
45
-
93,1
99,2
68
1,3
86,2
86,6
78
1,8
Test item
90 (p)
-
73,6
124,7
54
1,0
113,8
92,1
30
0,7
Test item
180 (p)
-
87,8
126
47
0,9
91,9
92,6
45
1,1
Medium control
+
100
100
53
100
100
55
Solvent Control
+
100
100
57
1
100
100
55
1
CPA
3,0
+
93,5
57,5
333
6,3
65,9
80,2
314
5,7
Test item
5,7
+
70,7
discontinued
87,4
discontinued
Test item
11,3
+
113,7
157,3
32
0,6
86,0
112,0
27
0,5
Test item
22,5
+
70,7
139,3
39
0,7
109,6
95,2
40
0,7
Test item
45
+
113,7
145,8
43
0,8
88,8
96,6
53
1,0
Test item
90 (p)
+
51,3
152,3
47
0,8
83,3
105,3
37
0,7
Test item
180 (p)
+
87,8
171,6
44
0,8
80,8
60,7
57
1,0
Experiment 2
Medium control
-
100
100
48
100
100
45
Solvent Control
-
100
100
48
1,0
100
100
41
1,0
MMS
13,0
-
67,6
56,6
314
6,5
31
58,2
296
6,6
Test item
5,7
-
114,7
discontinued
108,6
discontinued
Test item
11,3
-
102,1
122,1
42
0,9
127,9
134
40
1,0
Test item
22,5
-
58,6
125,2
43
0,9
52,6
176
38
0,9
Test item
45
-
111,9
119,6
44
0,9
93,9
92,5
33
0,8
Test item
90 (p)
-
117,7
95
45
0,9
123,1
121,1
45
1,1
Test item
180 (p)
-
109,3
150,1
38
0,8
155,9
126,8
58
1,4
Reference
|
Culture 1 |
Culture 2 |
||||||||
|
µg/mL |
S9 |
Rel cloning effic. |
Rel. total growth |
Mutant colonies /106cells |
Induction factor |
Rel cloning effic. |
Rel. total growth |
Mutant colonies /106cells |
Induction factor |
Experiment 1 |
||||||||||
Medium control |
0 |
- |
100.0 |
100.0 |
49 |
|
100.0 |
100.0 |
79 |
|
Solvent Control |
0 |
- |
100 |
100 |
54 |
1,0 |
100 |
100 |
42 |
1,0 |
MMS |
19,5 |
- |
50,0 |
17,5 |
672 |
13,6 |
33,3 |
23,0 |
716 |
9,0 |
Test item |
5,7 |
- |
73,6 |
discontinued |
116,1 |
discontinued |
||||
Test item |
11,3 |
- |
100 |
73,4 |
136 |
2,5 |
105,5 |
132,2 |
22 |
0,5 |
Test item |
22,5 |
- |
71,1 |
120,0 |
39 |
0,7 |
83,5 |
86,8 |
28 |
0,7 |
Test item |
45 |
- |
93,1 |
99,2 |
68 |
1,3 |
86,2 |
86,6 |
78 |
1,8 |
Test item |
90 (p) |
- |
73,6 |
124,7 |
54 |
1,0 |
113,8 |
92,1 |
30 |
0,7 |
Test item |
180 (p) |
- |
87,8 |
126 |
47 |
0,9 |
91,9 |
92,6 |
45 |
1,1 |
|
||||||||||
Medium control |
|
+ |
100 |
100 |
53 |
|
100 |
100 |
55 |
|
Solvent Control |
|
+ |
100 |
100 |
57 |
1 |
100 |
100 |
55 |
1 |
CPA |
3,0 |
+ |
93,5 |
57,5 |
333 |
6,3 |
65,9 |
80,2 |
314 |
5,7 |
Test item |
5,7 |
+ |
70,7 |
discontinued |
87,4 |
discontinued |
||||
Test item |
11,3 |
+ |
113,7 |
157,3 |
32 |
0,6 |
86,0 |
112,0 |
27 |
0,5 |
Test item |
22,5 |
+ |
70,7 |
139,3 |
39 |
0,7 |
109,6 |
95,2 |
40 |
0,7 |
Test item |
45 |
+ |
113,7 |
145,8 |
43 |
0,8 |
88,8 |
96,6 |
53 |
1,0 |
Test item |
90 (p) |
+ |
51,3 |
152,3 |
47 |
0,8 |
83,3 |
105,3 |
37 |
0,7 |
Test item |
180 (p) |
+ |
87,8 |
171,6 |
44 |
0,8 |
80,8 |
60,7 |
57 |
1,0 |
Experiment 2 |
||||||||||
Medium control |
|
- |
100 |
100 |
48 |
|
100 |
100 |
45 |
|
Solvent Control |
|
- |
100 |
100 |
48 |
1,0 |
100 |
100 |
41 |
1,0 |
MMS |
13,0 |
- |
67,6 |
56,6 |
314 |
6,5 |
31 |
58,2 |
296 |
6,6 |
Test item |
5,7 |
- |
114,7 |
discontinued |
108,6 |
discontinued |
||||
Test item |
11,3 |
- |
102,1 |
122,1 |
42 |
0,9 |
127,9 |
134 |
40 |
1,0 |
Test item |
22,5 |
- |
58,6 |
125,2 |
43 |
0,9 |
52,6 |
176 |
38 |
0,9 |
Test item |
45 |
- |
111,9 |
119,6 |
44 |
0,9 |
93,9 |
92,5 |
33 |
0,8 |
Test item |
90 (p) |
- |
117,7 |
95 |
45 |
0,9 |
123,1 |
121,1 |
45 |
1,1 |
Test item |
180 (p) |
- |
109,3 |
150,1 |
38 |
0,8 |
155,9 |
126,8 |
58 |
1,4 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Depending on the purity of the tested sample several tests in bacteria gave conflicting results. However, the higher quality studies with better characteriszed samples gave negative results in the Ames test. Negative results were also found in the assay in mammalian Mouse-Lymphoma cells in vitro.
Justification for selection of genetic toxicity endpoint
The mammalian cell test is the most relevant of the available studies
Justification for classification or non-classification
No Classification
The available valid data do not indicate a mutagenic hazard.
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.