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EC number: 266-235-8 | CAS number: 66204-44-2
- 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:
- August 10, 2000 to September 17, 2000 (experimental phase)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline study, well performed acoording to good scientific standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- CONTRAM ™MBO
- IUPAC Name:
- CONTRAM ™MBO
- Details on test material:
- - Name of test material (as cited in study report): OS 157339
- Common name: CONTRAM ™MBO
- Substance type: Formaldehyde releaser
- Composition of test material, percentage of components: Reaction product from paraformaldehyde and 2 hydroxypropylamine (ratio of 3:2)
- Physical state: Pale yellow liquid
- Analytical purity: No data, Sponsor's responsibility
- Lot/batch No.: OS 157339
- Expiration date of the lot/batch: No data, Sponsor's respondibility
- Stability under test conditions: No data
- Storage condition of test material: At room temperature in the dark
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Top agar (Difco) overlaid onto Vogel-Bonner minimal agar plate
- Properly maintained: yes
- Periodically checked for sterility: yes
- Periodically checked for karyotype stability: yes - Additional strain / cell type characteristics:
- other: Histidine deficiency S. typhimurium and tryptophan deficiency in E. coli
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 mix; male rats induced with oral phenobarbital and beta-naphthoflavone (80/100 mg/kg bw) on 3 consecutive days prior to S9-preparation.
- Test concentrations with justification for top dose:
- Vehicle (destilled water) control and 5, 15, 50, 150, 500, 1500 µg/plate in experiment 1; in experiment 2 TA100 (with MA) and TA98 (with and without MA) exposed to 5, 15, 50, 150, 300, 500 µg/plate and WP2uvrA (with and without MA) to 5, 15, 50, 150, 300, 500, 750 µg/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: : Test item had good solubility with water
Controls
- Untreated negative controls:
- other: In separate trials untreated control data given
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: N-ethyl-N’-nitro-N-nitrosoguanidine, 9-aminoacridine , 4-nitroquinoline-1-oxide, 2-aminoanthracene and benzo(a)pyrene
- Remarks:
- Without metabolic activation (MA) N-ethyl-N’-nitro-N-nitrosoguanidine: TA100, TA1535, WP2uvrA; 9-aminoacridine: TA1537; 4-nitroquinoline-1-oxide: TA98. With MA:2-aminoanthracene: TA100, TA1535 and TA1537, WP2uvrA; benzo(a)pyrene: TA 98
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
- Preincubation period: 10 hours
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3 replicates per dose, 2 independent experiments; vehicle (sterile distilled water) control and in separate trials untreated control data given.
NUMBER OF CELLS EVALUATED: Revertant colonies scored manually.
DETERMINATION OF CYTOTOXICITY
relative total growth - Evaluation criteria:
- The test item is considered positive if in at least one strain a dose-related and reproducible statistically significant increase in the number of revertant counts in obtained.
- Statistics:
- Dunnett's method of linear regression
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Preliminary range finding study with & without MA at 0.15-5000 µg/plate (10 dose levels) in TA 100 and E. coli WP2uvrA.
COMPARISON WITH HISTORICAL CONTROL DATA:
Yes
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In preliminary study toxic effects at 500 µg/plate in TA100 and at 1500 µg/plate in E.coli (with and without MA) - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Without metabolic activation
Valid negative and positive controls (also comparison with historical control data of this lab). No significant increases in revertants were observed in TA1535 and TA1537 at any dose level without MA (not shown in the Table). A dose-related, reproducible and statistically significant increase in the frequency of revertants was detected in TA98, TA100 (only 2ndexperiment), and WP2uvrA. However, the increase was only modest (see discussion below).
With metabolic activation
Valid negative and positive controls (also comparison with historical control data of this lab). No significant increases in revertants were observed in TA1535 and TA1537 at any dose level with MA (not shown in the Table). A dose-related, reproducible and statistically significant increase in the frequency of revertants were detected in TA98, TA100, and WP2uvrA (see Table above). However, the increase was only modest (see discussion below).
Table for number of revertant colonies in Experiment I
Average of 3 plates & standard deviation; historical control data
1998 and 1999
Concentration in µg/plate |
WP2uvrA- |
WP2uvrA- |
TA98 |
TA98 |
TA100 |
TA100 |
vehicle control |
14+-3.8 |
15+-4.4 |
29+-2.3 |
16+-4.6 |
140+-10 |
128+-11 |
historical con-trol (range) |
25 (13-41) |
23 (13-34) |
36 (22-54) |
31 (15-45) |
125 (81-170) |
124 (73-173) |
5 |
20+-6.7 |
18+-2.1 |
27+-5.0 |
17+-5.0 |
132+-9 |
124+-11 |
15 |
20+-3.5 |
20+-4.6 |
28+-3.8 |
17+-4.6 |
142+-13 |
135+-9 |
50 |
28+-3.5** |
18+-7.5 |
32+-5.5 |
21+-8.5 |
142+-1 |
132+-15 |
150 |
29+-2.1** |
19+-6.4 |
46+-4.4** |
32+-3.1** |
258+-16** |
135+-5 |
500 |
31+-7.2** |
34+-6.7** |
3+-1.5 V |
0 V |
0 V |
0 V |
1500 |
3+-1.5 V |
0 V |
0 T |
0 T |
0 T |
0 T |
positive control |
300+-19 |
614+-59 |
310+-13 |
163+-5 |
1519+-194 |
479+-39 |
Number of revertant colonies (average of 3 plates) in Experiment II |
||||||
Concentration in µg/plate |
WP2uvrA- |
WP2uvrA- |
TA98 |
TA98 |
TA100 |
TA100 |
vehicle control |
19+-6.1 |
18+-4.2 |
41+-1.5 |
27+-5.6 |
132+-17 |
95+-18 |
historical control (range) |
25 (13-41) |
23 (13-34) |
36 (22-54) |
31 (15-45) |
125 (81-170) |
124 (73-173) |
5 |
|
|
|
|
|
72+-3 |
15 |
22+-4.6 |
19+-4.4 |
39+-1.5 |
26+-10.0 |
115+-2 |
74+-7 |
50 |
21+-0.6 |
22+-6.8 |
47+-8.1 |
26+-4.5 |
139+-21 |
75+-3 |
100 |
|
|
53+-12.7 |
36+-17 |
159+-6* |
|
150 |
26+-8.1 |
23+-7.0 |
57+-4.6* |
31+-10.6 |
219+-14** |
142+-6.5** |
300 |
41+-2.9** |
35+-2.9** |
19+-2.6 V |
12+-1.7 S |
82+-7 S |
|
500 |
44+-8.1 |
29+-2.9* |
0 V |
0 V |
0 V |
0 V |
750 |
23+-3.6 S |
0 V |
|
|
|
|
1500 |
|
|
|
|
|
0 T |
positive control |
760+-89 |
430+-21 |
212+-21 |
153+-12 |
1438+-235 |
452+-35 |
MA: metabolic activation; *: p<0.05; **:p<0.005; S: sparse bacterial background lawn; V: very weak bacterial background lawn; T: no bacterial background lawn; nd: not done |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive
Under the experimental conditions described in this study the test substance induce gene mutation in bacteria even at non-cytotoxic concentrations. Authors concluded that the test substance was considered to be mutagenic. But the increase in revertants reached max. a 2-fold of the current control. Comparing the results with the historical control data of the same laboratory the detected increased in revertants were within the control range except TA100+MA in Exp.I and TA98 in Exp.II (but no 2-fold increase in comparison to the vehicle control, see Table above). Statistically significance in comparison with the concurrent control did not necessarily means also toxicological relevance. However, the effects were dose-dependent and reproducible. - Executive summary:
Study according to OECD guideline 471(adopted 1997). Salmonella typhimurium reverse mutation test in TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2uvrA at concentration levels of 0, 5, 15, 50, 150, 300, 500, 750, 1500 µg/plate with and without metabolic activation. The test item showed a weak positive, reproducible response.
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