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EC number: 203-403-1 | CAS number: 106-49-0
- 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
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline with acceptable restrictions: only 4 strains used, no cytotox. concentration given, no information on GLP
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Salmonella Mutagenicity tests: V. Results from the testing of 311 chemicals
- Author:
- Zeiger, E. et al.
- Year:
- 1 992
- Bibliographic source:
- Environm Mol Mutagen 19 [21], 2-141.
- Reference Type:
- secondary source
- Title:
- p-Toluidine - CAS No: 106-49-0 - SIDS Initial Assessment Report.
- Author:
- OECD
- Year:
- 2 005
- Bibliographic source:
- UNEP Publications
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- No GLP study. Only four strains were used. Number of replicated trials not reported
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- p-toluidine
- EC Number:
- 203-403-1
- EC Name:
- p-toluidine
- Cas Number:
- 106-49-0
- Molecular formula:
- C7H9N
- IUPAC Name:
- 4-methylaniline
- Details on test material:
- - Name of test material (as cited in study report): p-toluidine hydrochloride
- Analytical purity: 95.7%
Constituent 1
Method
- Target gene:
- his
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA97, TA98, TA100, TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix was prepared from Aroclor 1254-induced male Sprague-Dawley rats (RLI) and males Syrian Hamster (HLI) in 10 % and 30 % concentrations.
- Test concentrations with justification for top dose:
- 0, 33, 100, 333, 1000, 2000, 3333 µg/plate in water
- Vehicle / solvent:
- - Vehicle/solvent used: water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: see any other information on the material and methods
- Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
DETERMINATION OF CYTOTOXICITY
- Method: All chemicals were run initially in a toxicity assay to determine the appropriate dose range for the mutagenicity assay. The toxicity assay was performed using TA100 or the system developed by Waleh et al. 1982. Mutat. Res. 97:247-256. Toxic concentrations were defined as those that produced a descrease in the number of his+ colonies, or a clearing in the density of the background lawn, or both.
- Evaluation criteria:
- A chemical was judged mutagenic or weakly mutagenic if it produced a reproducible dose-related response over the solvent control, under single metabolic activation condition, in replicate trials. A chemical was judged questionable (?) if the results of individual trials were not reproducible, if increases in his+ revertants did not meet the criteria for a "+W" response, or if only single doses produced increases in his+ revertants in repeat trials. Chemicals were judged nonmutagenic (-) if they did not meet the critearia for a mutagenic or questionable response.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: Salmonella typhimurium TA97, TA98, TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- see remarks on results including tables and figures
- Cytotoxicity / choice of top concentrations:
- other: cytotoxicity was determined in preliminary experiments (no further information)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- other: cytotoxicity was determined in preliminary experiments (no further information)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: cytotoxicity was determined in preliminary experiments (no further information)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: other: Salmonella typhimurium TA97, TA98, TA100, TA1535
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1.Mutagenic responses (mean ± SEM; three plates) of Salmonella tester strains to p-toluidine HCl.
|
TA 100 |
TA 1535 |
||||||||||||||||||||||
DOSE |
NA (-) |
NA (-) |
10% HLI (?) |
30% HLI (+) |
30% HLI (+w) |
10% RLI (?) |
30% RLI (-) |
NA (-) |
10% HLI (-) |
30% HLI (-) |
10% RLI (-) |
30% RLI (-) |
||||||||||||
µg/PLATE |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
0 |
132 |
7.8 |
107 |
8.1 |
113 |
6.2 |
122 |
0.7 |
110 |
10.4 |
114 |
5.8 |
143 |
1.5 |
39 |
2.0 |
15 |
2.2 |
10 |
3.3 |
17 |
3.5 |
13 |
2.0 |
33 |
142 |
8.3 |
|
|
120 |
7.8 |
|
|
|
|
131 |
5.2 |
|
|
|
|
12 |
0.9 |
|
|
13 |
2.1 |
|
|
100 |
133 |
3.5 |
123 |
4.7 |
128 |
4.0 |
134 |
0.3 |
139 |
5.1 |
135 |
4.9 |
130 |
2.5 |
28 |
5.9 |
9 |
2.0 |
14 |
1.9 |
9 |
2.8 |
13 |
1.5 |
333 |
135 |
8.4 |
103 |
7.0 |
154 |
3.7 |
164 |
5.8 |
147 |
9.6 |
153 |
12.6 |
145 |
3.2 |
30 |
2.0 |
12 |
1.9 |
16 |
2.9 |
14 |
0.9 |
16 |
2.1 |
1000 |
137 |
5.1 |
122 |
6.0 |
146 |
4.4 |
219 |
23.4 |
158 |
9.5 |
157 |
3.3 |
155 |
14.2 |
32 |
2.3 |
16 |
2.5 |
18 |
1.9 |
13 |
2.2 |
15 |
1.8 |
2000 |
137s |
6.2 |
116s |
11.1 |
178s |
8.2 |
239s |
10.3 |
197s |
19.0 |
157s |
5.4 |
156s |
9.3 |
33 |
5.4 |
15s |
0.9 |
17 |
1.2 |
10s |
2.5 |
17 |
2.3 |
3333 |
|
|
111s |
7.3 |
|
|
256s |
6.9 |
191s |
10.7 |
|
|
156s |
8.6 |
17s |
3.5 |
|
|
17s |
2.7 |
|
|
11s |
1.5 |
POS |
1441 |
49.7 |
1516 |
49.8 |
1622 |
18.3 |
993 |
9.9 |
1952 |
66.7 |
1577 |
21.7 |
525 |
16.3 |
1131 |
12.1 |
149 |
9.0 |
288 |
16.7 |
133 |
7.0 |
134 |
9.5 |
Table 2.Mutagenic responses (mean ± SEM; three plates) of Salmonella tester strains to p-toluidine HCl
|
TA97 |
TA98 |
||||||||||||||||||
DOSE |
NA (-) |
10% HLI (?) |
30% HLI (-) |
10% RLI (-) |
30% RLI (-) |
NA (-) |
10% HLI (-) |
30% HLI (-) |
10% RLI (-) |
30% RLI (-) |
||||||||||
µg/PLATE |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
MEAN |
SEM |
0 |
138 |
4.3 |
110 |
6.6 |
194 |
12.8 |
135 |
4.2 |
233 |
6.4 |
17 |
3.5 |
30 |
3.9 |
29 |
2.2 |
39 |
2.2 |
40 |
1.7 |
33 |
|
|
140 |
12.2 |
|
|
157 |
4.3 |
|
|
|
|
37 |
3.9 |
|
|
40 |
1.7 |
|
|
100 |
131 |
0.3 |
172 |
3.0 |
205 |
8.7 |
146 |
10.2 |
227 |
17.2 |
15 |
1.5 |
35 |
4.1 |
28 |
1.5 |
43 |
3.5 |
34 |
2.6 |
333 |
127 |
7.2 |
148 |
1.5 |
212 |
12.7 |
151 |
6.3 |
220 |
14.6 |
16 |
5.7 |
36 |
1.2 |
40 |
1.7 |
44 |
1.2 |
36 |
4.7 |
1000 |
133s |
3.5 |
135 |
8.3 |
200 |
5.8 |
173 |
5.0 |
193 |
3.9 |
19 |
2.6 |
38 |
5.0 |
44 |
7.7 |
38 |
2.8 |
47 |
5.2 |
2000 |
122s |
2.0 |
144s |
7.5 |
209s |
8.9 |
166s |
6.7 |
218s |
8.8 |
15 |
0.9 |
38 |
1.5 |
45s |
3.1 |
41 |
2.9 |
35 |
0.9 |
3333 |
99s |
5.7 |
|
|
194s |
2.6 |
|
|
184s |
6.4 |
13s |
1.2 |
|
|
46s |
3.6 |
|
|
40s |
4.4 |
POS |
1257 |
33.7 |
1011 |
75.0 |
840 |
31.0 |
1087 |
30.4 |
477 |
11.8 |
1112 |
32.0 |
1930 |
44.6 |
1251 |
7.4 |
1571 |
43.9 |
443 |
22.0 |
HLI =Aroclor1254-induced hamster liver S9
RLI =Aroclor1254-induced rat liver S9;
s = slight clearing of background lawn (colonies not counted)
+ = mutagenic
+W= weakly mutagenic
? = questionable response;
- =non mutagenic
POS: positive control
Negative results were noted in all strains with and without metabolic activation except TA100 in the presence of hamster liver S9-mix.
The positive controls were functional.
Overall conclusion: weak positive
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation in Salmonella typhimurium strain TA100
negative without metabolic activation in Salmonella typhimurium strain TA100
negative in Salmonella typhimurium strains TA97, 98 and 1535 - Executive summary:
Zeiger (1992)
The Ames test was conducted with a method similar to OECD guideline 471 with deviations (only four strains were used. Positive controls were used, but the name of the substances were not mentioned)
p-toluidine in concentrations ranging between 0 and 3333 µg/plate using Salmonella typhimurium TA97, TA98 and TA1535 without metabolic activation and in the presence of hamster or rat liver S9-mix was found not mutagenic. Salmonella typhimurium TA100 was tested negative without metabolic activation and in the presence of rat liver S9-mix but was positive in the presence of hamster liver S9-mix. Concurrent positive controls were always functional.
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