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EC number: 237-163-4 | CAS number: 13676-54-5
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 February 1988 - 18 April 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study report does not cite specific official test guidelines, however the report is thorough and the test conditions are well documented. It may be determined that the methodology is broadly consistent with modern test methods and the report does include a claim that the study was conducted according to the General Principles of Good Laboratory Practice; on this basis the study is considered reliable with restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 1,1'-(methylenedi-p-phenylene)bismaleimide
- EC Number:
- 237-163-4
- EC Name:
- 1,1'-(methylenedi-p-phenylene)bismaleimide
- Cas Number:
- 13676-54-5
- Molecular formula:
- C21H14N2O4
- IUPAC Name:
- 1-(4-{[4-(2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)phenyl]methyl}phenyl)-2,5-dihydro-1H-pyrrole-2,5-dione
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): MB-3000, N,N'-(4,4'-diphenylenemethylene) bismaleimide
- Physical state: Pale yellow powder
- Lot/batch No.: CX-1074
- Storage condition of test material: Room temperature
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver microsomal enzyme fraction
- Test concentrations with justification for top dose:
- 2.5, 5, 10 and 20 μg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Exposure duration: 24 hours (without S-9) and 6 hours (with S-9) + 18 hours in treatment free media
SPINDLE INHIBITOR (cytogenetic assays): demecolcine (colcemid 0.1μg/mL) 2 hours before required harvest time
STAIN (for cytogenetic assays): 2% Gurrs Giemsa R66
NUMBER OF REPLICATIONS: 2 per treatment with S-9 and 2 without S-9
NUMBER OF CELLS EVALUATED: 100 consecutive well spread metaphases from each culture
DETERMINATION OF CYTOTOXICITY
- Method: count of cells % of control
COUNT OF CELLS with POLYPLOIDY: yes - Evaluation criteria:
- KUEMS Guidelines for mutagenicity Testing (1983)
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- 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
- Remarks on result:
- other: strain/cell type: CHO-K1 BH4cell line
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Cytotoxicity
Cell counts for the treatment without S-9 24 hour treatment
|
Without S-9 |
||||
Culture A |
Culture B |
Mean % |
|||
Concentration of MB-3000 (μg/mL) |
No of cells X105 |
% of control |
No of cells X105 |
% of control |
|
0 |
3.75 |
100 |
2.86 |
100 |
100 |
2.5 |
2.96 |
79 |
3.06 |
107 |
93 |
5.0 |
2.35 |
63 |
2.69 |
94 |
78.5 |
10.0 |
1.86 |
50 |
1.69 |
59 |
54.5 |
20.0 |
1.34 |
36 |
1.59 |
56 |
46.0 |
EMS 1 mg/mL |
1.84 |
49 |
1.78 |
62 |
55.5 |
Cell counts for the treatment with S-9 6 hour treatment
|
With S-9 |
||||
Culture A |
Culture B |
Mean % |
|||
Concentration of MB-3000 (μg/mL) |
No of cells X105 |
% of control |
No of cells X105 |
% of control |
|
0 |
1.80 |
100 |
1.52 |
100 |
100 |
2.5 |
1.91 |
106 |
1.45 |
95 |
100.5 |
5.0 |
1.66 |
92 |
1.61 |
106 |
99 |
10.0 |
1.23 |
68 |
1.37 |
90 |
79 |
20.0 |
1.07 |
59 |
0.68 |
45 |
52 |
CP 25 ug/mL |
1.69 |
94 |
1.63 |
107 |
100.5 |
Result of Chromosome aberration assay
Treatment without S-9
Treatment group |
Treatment time (hr) |
Con-centration |
No of diploid cells scored |
Cells with polyploidy |
No of cells with observed structural aberrations |
|||||||||||
N |
% |
Judge-ment |
GAPS |
Chromatid |
Chromosome |
Others |
Total No Cells with aberration |
Judge-ment |
||||||||
g |
ctb |
cte |
csb |
cse |
X |
Z |
-g |
+g |
||||||||
Solvent control |
24 |
0 |
100 |
10 |
(9.1) |
- |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
3 |
- |
100 |
11 |
(9.9) |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
|||||
200 |
21 |
(9.5) |
3 (1.5) |
0(0) |
0(0) |
2(1) |
0(0) |
0(0) |
0(0) |
2(1) |
5(2.5) |
|||||
MB-3000 |
24 |
2.5 |
100 |
12 |
(10.7) |
- |
1 |
2 |
0 |
2 |
1 |
0 |
0 |
5 |
6 |
+ |
100 |
8 |
(7.4) |
5 |
0 |
0 |
4 |
1 |
0 |
0 |
5 |
10 |
|||||
200 |
20 |
(9.1) |
6 (3) |
2 (1) |
0(0) |
6(3) |
2(1) |
0(0) |
0(0) |
10(5) |
16 (8) |
|||||
5.0 |
100 |
17 |
(14.5) |
- |
4 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
5 |
+ |
||
100 |
6 |
(5.7) |
4 |
0 |
0 |
5 |
0 |
2 |
1 |
7 |
10 |
|||||
200 |
23 |
(10.3) |
8 (4) |
0(0) |
0(0) |
6(3) |
0(0) |
2(1) |
1(0.5) |
8(4) |
15(7.5) |
|||||
10.0 |
100 |
11 |
(9.9) |
- |
7 |
0 |
1 |
9 |
0 |
0 |
1 |
10 |
15 |
+ |
||
100 |
8 |
(7.4) |
4 |
4 |
1 |
4 |
1 |
0 |
6 |
8 |
12 |
|||||
200 |
19 |
(8.7) |
11 (5.5) |
4(2) |
2(1) |
13(6.5) |
1(0.5) |
0(0) |
7(3.5) |
18(9) |
27(13.5) |
|||||
20.0 |
100 |
9 |
(8.3) |
- |
3 |
5 |
2 |
5 |
2 |
0 |
4 |
13 |
15 |
+ |
||
100 |
9 |
(8.3) |
6 |
2 |
1 |
5 |
0 |
1 |
5 |
7 |
13 |
|||||
200 |
18 |
(8.3) |
9 (4.5) |
7(3.5) |
3(1.5) |
10(5) |
2(1) |
1(0.5) |
9(10.5) |
20 |
28(14) |
|||||
EMS |
24 |
1000 |
50 |
6 |
(10.7) |
- |
22 |
17 |
21 |
14 |
3 |
4 |
0 |
43 |
44 |
- |
50 |
3 |
(5.7) |
14 |
12 |
15 |
19 |
3 |
3 |
0 |
33 |
39 |
|||||
100 |
9 |
(8.3) |
36 (36) |
29(29) |
36 (36) |
33(33) |
6(6) |
7(7) |
0(0) |
76(76) |
83(83) |
Treatment with S-9
Treatment group |
Treatment time (hr) |
Con-centration |
No of diploid cells scored |
Cells with polyploidy |
No of cells with observed structural aberrations |
|||||||||||
N |
% |
Judge-ment |
GAPS |
Chromatid |
Chromosome |
Others |
Total No Cells with aberration |
Judge-ment |
||||||||
g |
ctb |
cte |
csb |
cse |
X |
Z |
-g |
+g |
||||||||
Solvent control |
6 |
0 |
100 |
14 |
(12.2) |
- |
6 |
1 |
1 |
3 |
0 |
0 |
0 |
5 |
11 |
- |
100 |
2 |
(2.0) |
4 |
1 |
1 |
3 |
1 |
0 |
0 |
6 |
10 |
|||||
200 |
16 |
(7.4) |
10 (5) |
2(1) |
2(1) |
6(3) |
1(0.5) |
0(0) |
0(0) |
11(5.5) |
21(10.5) |
|||||
MB-3000 |
6 |
2.5 |
100 |
10 |
(9.1) |
- |
1 |
0 |
0 |
1 |
1 |
0 |
0 |
2 |
3 |
+ |
100 |
8 |
(7.4) |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
|||||
200 |
18 |
(8.3) |
2 (1) |
0(0) |
0(0) |
1(0.5) |
1(0.5) |
0(0) |
0(0) |
2(1) |
4 (2) |
|||||
5.0 |
100 |
6 |
(5.7) |
- |
2 |
0 |
2 |
1 |
0 |
0 |
2 |
3 |
5 |
+ |
||
100 |
6 |
(5.7) |
6 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
6 |
|||||
200 |
12 |
(5.7) |
8 (4) |
1(0.5) |
3(1.5) |
1(0.5) |
0(0) |
0(0) |
2(1) |
4(2) |
11(5.5) |
|||||
10.0 |
100 |
11 |
(9.9) |
- |
7 |
6 |
3 |
2 |
0 |
0 |
4 |
11 |
16 |
+ |
||
100 |
8 |
(7.4) |
3 |
2 |
4 |
5 |
1 |
0 |
2 |
9 |
11 |
|||||
200 |
19 |
(8.7) |
10 (5) |
8(4) |
7(3.5) |
7(3.5) |
1(0.5) |
0(0) |
6(3) |
20(10) |
27(13.5) |
|||||
20.0 |
100 |
4 |
(3.8) |
- |
7 |
8 |
2 |
4 |
0 |
0 |
8 |
11 |
17 |
+ |
||
100 |
6 |
(5.7) |
6 |
3 |
7 |
4 |
2 |
0 |
9 |
15 |
19 |
|||||
200 |
10 |
(4.8) |
13 (6.5) |
11(3.5) |
9(4.5) |
8(4) |
2(1) |
0(0) |
17(8.5) |
26(13) |
36(18) |
|||||
CP |
6 |
25 |
50 |
8 |
(13.8) |
- |
9 |
9 |
14 |
29 |
2 |
0 |
0 |
38 |
40 |
- |
50 |
8 |
(13.8) |
8 |
11 |
7 |
33 |
1 |
0 |
0 |
42 |
43 |
|||||
100 |
16 |
(13.8) |
17 (17) |
20(20) |
21(21) |
62(62) |
3(3) |
0(0) |
0(0) |
80(80) |
83(83) |
Applicant's summary and conclusion
- Conclusions:
- It was concluded that the test substance showed evidence of cytogenic and clastogenic activities in this in vitro mamalian cell system under the test conditions employed.
- Executive summary:
A test was conducted (Safe Pharm Laboratories, 1988) in vitro in Chinese Hamster Ovary cells to assess the clastogenic potential of BMI in mammalian cells. The test was conducted using a 6-hour exposure period in the presence of metabolic activation (achieved by adding induced rat liver homogenate metabolising system) and a 24-hour exposure period in the absence of metabolic activation.
Significant dose-related increases in both toxicity and the frequency of aberrations were observed under both regimes of treatment with the test material. BMI was concluded to be clastogenic to CHO cells in vitro.
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