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EC number: 202-430-6 | CAS number: 95-54-5
- 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
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- Endpoint summary
- Stability
- Biodegradation
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- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: other: damage of chromosomes or mitotic apparatus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Important aspects are in line with current OECD guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- o-phenylenediamine
- EC Number:
- 202-430-6
- EC Name:
- o-phenylenediamine
- Cas Number:
- 95-54-5
- Molecular formula:
- C6H8N2
- IUPAC Name:
- benzene-1,2-diamine
- Details on test material:
- - Name of test material (as cited in study report): Hoe 37197 O T AT201 (o-Phenylendiamin)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: NMRI strain Hoe NMRKf (SPF71)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Pharma Forschung Toxikologie, Kastengrund, Hattersheim, Germany
- Age at study initiation: 10-12 weeks
- Weight at study initiation: male: 32 - 40 g, female: 23 - 29 g
- Assigned to test groups randomly: yes
- Fasting period before study: no fasting period
- Housing: plastic cages, groups of five, same-sex
- Diet ad libitum: yes
- Water ad libitum: yes
- Acclimation period: not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Deionised water for the test substance and aqua dest. for the positive control
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DOSE PREPARATION
- Rate of preparation: daily before application,
- Stock solution: 1250 mg test substance ad 50 ml
- Dose concentrations: dilutions of stock solution - Duration of treatment / exposure:
- In a range finder test 250 mg/kg bw. was found to be the max. tolerable dose.
Two applications at 24 hours intervals. 6 hours after the second application the animals were killed. - Frequency of treatment:
- Two applications at 24 hours intervals.
- Post exposure period:
- 6 hours after the second application the animals were killed.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0; 2.5; 25; and 250 mg/kg bw.
Basis:
other: nominal dose administered
- No. of animals per sex per dose:
- 5 male and 5 female mice
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- Cyclophophamid (Endoxan, Edoxan W.Z. of company Asta, Brackwede): 100 mg/kg bw
Examinations
- Tissues and cell types examined:
- bone marrow erythroctes
- Details of tissue and slide preparation:
- Cells are removed from femures and poured in 5 ml of fetal calf's serum. The mixture was centrifuged at 1000 RPM. One drop of the cell suspension was spread on an object slide and dried for 24h at room temperature. Staining was done using May-Grünwaldt- and Giesema-solution.
- Evaluation criteria:
- 2000 polychromatic erythorcytes were examined for micronuclei containing cells. Additionally 1000 monochromatic erythrocytes were examined for micronuclei containing cells.
- Statistics:
- Binomial distribution, for increase, 90% confidence interval
Nemeny / Dunnett, deviation from control, 95% confidence interval
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- positive
- Remarks:
- at 250 mg/kg bw
- Toxicity:
- yes
- Remarks:
- >250 mg/kg bw
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): significant increase at 250 mg/kg, no effects at lower doses
- Ratio of PCE/NCE (for Micronucleus assay): uneffected
Any other information on results incl. tables
Dose mg/kg |
Animal No |
MN per 2000 PCE |
MN per 1000 NCE |
Ratio of PCE/NCE |
||||||||
|
m |
f |
m |
f |
m |
f |
m |
f |
||||
Control |
1 |
6 |
4 |
4 |
2 |
3 |
778 |
: |
1000 |
1231 |
: |
1000 |
2 |
7 |
5 |
14 |
1 |
1 |
1082 |
: |
1000 |
1210 |
: |
1000 |
|
3 |
8 |
16 |
8 |
3 |
1 |
975 |
: |
1000 |
1161 |
: |
1000 |
|
4 |
9 |
16 |
9 |
1 |
1 |
1102 |
: |
1000 |
1019 |
: |
1000 |
|
5 |
10 |
15 |
3 |
0 |
1 |
972 |
: |
1000 |
1115 |
: |
1000 |
|
2.5 |
11 |
16 |
14 |
7 |
1 |
0 |
972 |
: |
1000 |
1199 |
: |
1000 |
12 |
17 |
3 |
12 |
1 |
2 |
952 |
: |
1000 |
1148 |
: |
1000 |
|
13 |
18 |
9 |
6 |
2 |
2 |
1175 |
: |
1000 |
1291 |
: |
1000 |
|
14 |
19 |
11 |
11 |
2 |
1 |
1023 |
: |
1000 |
1087 |
: |
1000 |
|
15 |
20 |
7 |
6 |
1 |
1 |
868 |
: |
1000 |
981 |
: |
1000 |
|
25.0 |
21 |
26 |
10 |
6 |
1 |
0 |
914 |
: |
1000 |
1060 |
: |
1000 |
22 |
27 |
6 |
14 |
0 |
0 |
1093 |
: |
1000 |
1107 |
: |
1000 |
|
23 |
28 |
9 |
6 |
0 |
2 |
1168 |
: |
1000 |
1115 |
: |
1000 |
|
24 |
29 |
9 |
5 |
2 |
0 |
1011 |
: |
1000 |
977 |
: |
1000 |
|
25 |
30 |
11 |
15 |
1 |
1 |
1053 |
: |
1000 |
1147 |
: |
1000 |
|
250.0 |
31 |
36 |
24 |
23 |
1 |
0 |
781 |
: |
1000 |
1133 |
: |
1000 |
32 |
37 |
23 |
25 |
0 |
0 |
823 |
: |
1000 |
557 |
: |
1000 |
|
33 |
37 |
27 |
20 |
1 |
1 |
928 |
: |
1000 |
778 |
: |
1000 |
|
34 |
39 |
28 |
19 |
2 |
1 |
100 |
: |
1000 |
814 |
: |
1000 |
|
35 |
40 |
22 |
20 |
0 |
0 |
826 |
: |
1000 |
856 |
: |
1000 |
|
100.0 Cyclophosphamid |
41 |
46 |
147 |
93 |
3 |
1 |
863 |
: |
1000 |
758 |
: |
1000 |
42 |
47 |
152 |
107 |
1 |
1 |
511 |
: |
1000 |
600 |
: |
1000 |
|
43 |
48 |
108 |
139 |
2 |
2 |
542 |
: |
1000 |
586 |
: |
1000 |
|
44 |
49 |
105 |
136 |
1 |
2 |
567 |
: |
1000 |
459 |
: |
1000 |
|
45 |
50 |
129 |
158 |
1 |
3 |
535 |
: |
1000 |
629 |
: |
1000 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): positive
Significant increase of micronucleated polychromatic erythrocytes at the highest dose level tested (250 mg/kg) in male an female mice.
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