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EC number: 205-771-9 | CAS number: 150-78-7
- 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
Two Ames tests with negative response are available.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP conditions
- Qualifier:
- according to guideline
- Guideline:
- other: NTP protocols
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Induced S9 mix with Aroclor 1254, from rat or hamster liver cells.
- Test concentrations with justification for top dose:
- 0; 10; 33; 100; 333; 666; 750; 900; 1000; 2000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility of the test material - Untreated negative controls:
- yes
- Remarks:
- choline chloride, glycerol, glycine, mannitol and sodium phosphate.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- culture medium
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene on all strains with rat (1.5 µg/plate) and hamster (0.75 µg/plate) S9; 4-Nitro-o-phenylenediamine on TA98 without S9 (12µg/plate); sodium azide on TA100 and TA1535 without S9 (2.5 µg/plate); 9-aminoacridine on TA1537 (80 µg/plate)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation with S9 mix or buffer
DURATION
- pre-incubation period: 20 min at 37°C
- Exposure duration of incubation: 48 h at 37°C - Evaluation criteria:
- Although procedures for the statistical analysis of Salmonella plate test data have been developed [Margolin et al, 1981], they were not incorporated
into the initial data evaluations. The data were evaluated in an ad hoc manner by each testing laboratory and by NTP personnel. Prior to statistical
analysis no formal rules were used; however, a positive response was indicated by a reproducible, dose-related increase, whether it be twofold over
background or not. The matrix of test strains and activation systems used allowed the investigators to detect trends or patterns that might not be
as evident if only one strain and activation system were examined. In addition to the standard "positive" and "negative" categories, there is also
"questionable" (or "inconclusive"). This applied to low-level responses that were not reproducible within the laboratory or to results that showed a
definite trend but with which the investigator did not feel comfortable in making a " +" or " -" decision. It also included tests in which an elevated
revertant colony yield occurred at only a single dose level. After a decision on the mutagenicity of a sample was made, a request to decode the
sample was sent to the repository, and the code was broken. - Statistics:
- The data were subsequently evaluated using an analysis based on the models presented by Margolin et al [1981]. As a result of these statistical
analyses, a number of calls were changed from the original "negative" to "equivocal." The statistical analysis did not result in any "positive" or
"equivocal" calls being called "negative".
Because the criteria for "positive" or "questionable" decisions have evolved during the course of the study and because the recent use of statistical
analysis, some of the results differ from the initial evaluations published in the NTP Technical Bulletins (1980 to 1983). - Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- yes, slight to toxic for all strains at high concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
Negative with and without metabolic acivation.- Executive summary:
In a reverse gene mutation assay in bacteria (Haworth, 1983), strains TA98, TA100, TA1535 and TA1537 of S. typhimurium were exposed to paradimethoxybenzene at concentrations of 0 to 2000 µg/plate in the presence and absence of mammalian metabolic activation (rat or hamster liver cells).
Paradimethoxybenzene was tested up to cytotoxic concentrations.
The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity bacterial reverse gene mutation 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:
- from 22 feb 1988 to 20 june 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537 and TA1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from rat liver cells, induced with Aroclor 1254
- Test concentrations with justification for top dose:
- 0, 10, 100, 500, 1000 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: usually used in this type of test. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see details below
- Details on test system and experimental conditions:
- Positive controls:
- Without metabolic activation: Sodium azide (3 µg/plate) for TA100 and TA1535; 9-Aminoacridine for TA1537; 2-Nitrofluorene (0.5 µg/plate) for TA98 and TA1538.
- With metabolic activation: 2-Aminofluorene (5 µg/plate) for TA98 and TA1538.
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- incubation period: 48 hours at 37°C
- Exposure duration: 48 hours
NUMBER OF REPLICATES: 3 - Evaluation criteria:
- - in TA 98 and TA 100: a test article is considered as positive if it produce at least a 2-fold increase in the mean revertant per plate of at least one of these tester strains over the mean revertants per plate of the appropriate vehicle control.
This increase in the number of revertant must be accompanied by a dose response with increasing concentrations of the test article
- in TA 1535, TA 1537 and TA 1538: idem, but a 3-fold increase is required - Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537 and TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
Negative in Ames test, with and without metabolic activation.- Executive summary:
In a reverse gene mutation assay in bacteria (Hoechst, 1988), strains TA98, TA 100, TA 1535, TA 1537 and TA 1538 of S. typhimurium were exposed to Paradimethoxybenzene (purity unknown), in DMSO at concentrations of 0, 10, 100, 500, 1000 and 5000 µg/plate in the presence and absence of mammalian metabolic activation (plate incorporation method).
Paradimethoxybenzene was tested up to the limit concentration (5000 µg/plate). It was not mutagenic in Ames test.
The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
Referenceopen allclose all
Strain: TA1535
Dose |
No Activation |
No Activation |
No Activation |
No Activation |
10% HLI |
10% HLI |
10% RLI |
10% RLI |
||||||||
Dose units |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 |
23 |
2 |
13 |
1.8 |
26 |
1.2 |
11 |
2.6 |
9 |
1.8 |
7 |
1.2 |
11 |
0.9 |
11 |
0.9 |
10 |
|
|
20 |
1.7 |
|
|
|
|
|
|
6 |
0.9 |
|
|
6 |
0.6 |
33 |
33 |
1.7 |
21 |
2.6 |
21 |
4.2 |
17 |
1 |
13 |
1.3 |
7 |
2 |
10 |
1 |
9 |
2.5 |
100 |
27 |
2 |
23 |
0.7 |
18 |
3.8 |
10 |
0.7 |
11 |
0.6 |
7 |
1.2 |
14 |
3.5 |
9 |
2.7 |
333 |
24 |
6.4 |
41 |
1.5 |
21 |
1.8 |
15 |
1.8 |
9 |
2 |
8 |
1.5 |
10 |
1.8 |
6 |
1.2 |
666 |
|
|
106 |
3 |
23s |
0.6 |
14s |
1 |
|
|
7 |
1.2 |
|
|
7 |
1.2 |
750 |
|
|
|
|
18s |
1.5 |
13s |
1.9 |
|
|
|
|
|
|
|
|
900 |
|
|
|
|
14s |
5.8 |
8s |
4.1 |
|
|
|
|
|
|
|
|
1000 |
T |
|
|
|
|
|
|
11s |
0.5 |
|
|
5s |
1 |
|
|
|
2000 |
T |
|
|
|
|
|
|
T |
|
|
T |
|
|
|||
Positive Control |
1408 |
20.8 |
1446 |
11.7 |
2002 |
67.1 |
1413 |
91.8 |
148 |
6.8 |
85 |
5.9 |
77 |
1 |
53 |
8. |
Strain: TA100
Dose |
No Activation |
No Activation |
No Activation |
No Activation |
10% HLI |
10% HLI |
10% RLI |
10% RLI |
||||||||
Dose units |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 |
97 |
2.1 |
82 |
5 |
103 |
11.9 |
108 |
6.7 |
85 |
6.9 |
82 |
6.1 |
92 |
13.2 |
81 |
6.2 |
10 |
|
|
88 |
12.9 |
|
|
|
|
|
|
83 |
8.6 |
|
|
70 |
8.1 |
33 |
108 |
9.8 |
91 |
4.3 |
99 |
4.5 |
103 |
15.9 |
91 |
3.8 |
75 |
2.2 |
98 |
6.2 |
74 |
2.9 |
100 |
124 |
2 |
99 |
9.5 |
105 |
8.5 |
107 |
7.6 |
84 |
6.5 |
106 |
8.4 |
98 |
4.3 |
82 |
8.4 |
333 |
109 |
5.4 |
141 |
2.3 |
96 |
4.7 |
94 |
8.7 |
92 |
5.2 |
83 |
0.9 |
99 |
9 |
81 |
8.9 |
666 |
|
|
246 |
17.2 |
101 |
3.8 |
114s |
12.7 |
|
|
75 |
5 |
|
|
84 |
3.5 |
750 |
|
|
|
|
105s |
8.1 |
116s |
10.1 |
|
|
|
|
|
|
|
|
900 |
|
|
|
|
74s |
33.5 |
62s |
27 |
|
|
|
|
|
|
|
|
1000 |
T |
|
|
|
|
|
|
69s |
9.5 |
|
|
T |
|
|
||
2000 |
T |
|
|
|
|
|
|
T |
|
|
T |
|
|
|||
Positive Control |
1919 |
39.3 |
2152 |
99.5 |
2173 |
58.7 |
1590 |
94.7 |
1634 |
59.6 |
861 |
16.2 |
1303 |
116.4 |
457 |
35.9 |
Strain: TA98
Dose |
No Activation |
No Activation |
10% HLI |
10% HLI |
10% RLI |
10% RLI |
||||||
Dose units |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 |
19 |
2.5 |
18 |
5.1 |
29 |
3.3 |
23 |
0.9 |
20 |
3.8 |
22 |
2.9 |
10 |
|
|
16 |
3.6 |
|
|
16 |
1.7 |
|
|
21 |
2.4 |
33 |
14 |
0.9 |
17 |
3.8 |
27 |
2.3 |
22 |
3.2 |
22 |
1.2 |
24 |
0.7 |
100 |
17 |
2.3 |
20 |
4.1 |
29 |
2.4 |
22 |
3 |
19 |
4.1 |
22 |
3.1 |
333 |
16 |
1.5 |
15 |
3.3 |
23 |
0.9 |
15 |
1.9 |
33 |
1.7 |
21 |
1.2 |
666 |
|
|
14 |
3.3 |
|
|
21 |
1.5 |
|
|
20 |
1.2 |
1000 |
T |
|
|
27s |
6.5 |
|
|
T |
|
|
||
2000 |
T |
|
|
T |
|
|
T |
|
|
|||
Positive Control |
1174 |
17.5 |
1352 |
55.2 |
983 |
53.9 |
808 |
31.9 |
529 |
73.4 |
532 |
18.2 |
Strain: TA1537
Dose |
No Activation |
No Activation |
10% HLI |
10% HLI |
10% RLI |
10% RLI |
||||||
Dose units |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
Mean |
± SEM |
0 |
8 |
1.9 |
3 |
0.6 |
10 |
1.7 |
5 |
0.7 |
10 |
1 |
6 |
2.6 |
10 |
|
|
5 |
1.2 |
|
|
6 |
0.3 |
|
|
5 |
0.6 |
33 |
6 |
0.7 |
4 |
1.2 |
9 |
0.3 |
4 |
1.2 |
7 |
1.5 |
3 |
0.3 |
100 |
6 |
0.9 |
3 |
0.9 |
7 |
0.7 |
3 |
0.7 |
10 |
3.7 |
4 |
0.6 |
333 |
8 |
1.3 |
4 |
1.2 |
10 |
2.3 |
5 |
0.7 |
9 |
0.9 |
8 |
2.5 |
666 |
|
|
5 |
0.7 |
|
|
5 |
1.2 |
|
|
7 |
3.7 |
1000 |
T |
|
|
8s |
1 |
|
|
9s |
2.6 |
|
|
|
2000 |
T |
|
|
T |
|
|
T |
|
|
|||
Positive Control |
383 |
200.3 |
518 |
52.7 |
206 |
29.5 |
105 |
14.5 |
73 |
4.7 |
58 |
3.5 |
Tables of results (2 studies):
|
TA 98 |
TA 100 |
TA 1535 |
||||||
Conc. |
-S9 |
+S9 |
Cytotoxic |
-S9 |
+S9 |
Cytotoxic |
-S9 |
+S9 |
Cytotoxic |
0* |
25/21 |
28/28 |
no |
94/94 |
92 |
no |
15/22 |
11/14 |
no |
10 |
25/20 |
29/28 |
no |
95/85 |
87 |
no |
13/14 |
12/10 |
no |
100 |
20/19 |
34/27 |
no |
96/98 |
85 |
no |
21/18 |
13/15 |
no |
500 |
18/19 |
28/32 |
no |
105/96 |
84 |
no |
18/18 |
15/12 |
no |
1000 |
20/24 |
21/33 |
no |
98/95 |
93 |
no |
18/27 |
9/17 |
no |
5000 |
14/14 |
10/1/ |
no |
84/83 |
79 |
no |
15/25 |
8/9 |
no |
Positive control |
182/216 |
2012/1556 |
no |
1036/889 |
/ |
no |
938/697 |
/ |
no |
|
TA 1537 |
TA 1538 |
||||
Conc. |
-S9 |
+S9 |
Cytotoxic |
-S9 |
+S9 |
Cytotoxic |
0* |
6/7 |
7/6 |
no |
10/12 |
22/21 |
no |
10 |
7/7 |
7/6 |
no |
11/11 |
28/22 |
no |
100 |
7/5 |
8/5 |
no |
14/13 |
25/25 |
no |
500 |
9/6 |
7/9 |
no |
8/9 |
21/24 |
no |
1000 |
6/6 |
9/8 |
no |
13/14 |
21/24 |
no |
5000 |
7/6 |
7/4 |
no |
14/13 |
22/17 |
no |
Positive control |
1419/1563 |
/ |
no |
283/239 |
1947/1435 |
no |
*solvent control with DMSO
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Genotoxicity in vitro:
Two studies were available: one with relaibilty 1 (GLP study, Hoechst, 1988) and another one with reliability 2 (Haworth, 1983). They were selected as key studies.
In these reverse gene mutation assays in bacteria, strains TA98, TA100, TA1535, TA1537 and TA1538 of S. typhimurium were exposed to paradimethoxybenzene at concentrations of 0 to 5000 µg/plate in the presence and absence of mammalian metabolic activation (rat or hamster liver cells).
Paradimethoxybenzene was tested up to cytotoxic concentrations.
The positive controls induced the appropriate responses in the corresponding strains.
There was no evidence of induced mutant colonies over background in these two studies.
Genotoxicity in vivo:
Only one study (Hoechst, 1996) was available and was selected as key study.
The micronucleus test was performed with Paradimethoxybenzene, according to the OECD 474 guideline under GLP conditions.
The test compound was suspended in starch mucilage and was given once as an orally dose of 2000 mg/kg bw to male and female NMRI mice, based on the results of a preliminary study.
According to the test procedure, the animals were killed 12, 24 or 48 hours after administration.
Endoxan (cyclophosphamide in distilled water) was used as positive control substance and was administered once orally at a dose of 50 mg/kg bw.
The number of polychromatic and normochromatic erythrocytes containing micronuclei was not increased. The ratio of polychromatic/normochromatic erythrocytes in both male and female animals remained unaffected by the treatment with Paradimethoxybenzene and was statistically not different from the control values.
Positive control induced in both males and females a marked statistically significant increase in the number of polychromatic cells with micronuclei, indicating the sensitivity of the test system. The ratio of polychromatic erythrocytes to normocytes was not changed to a significant extent.
Under the test conditions, the results indicate that Paradimethoxybenzene is not mutagenic in the micronucleus test.
Justification for classification or non-classification
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.