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EC number: 224-923-5 | CAS number: 4553-62-2
- 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:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study performed similarly to OECD guidelines (Nr. 471) but the study was not performed with the GLP. The E. coli or S. thyphimurium TA102 were not tested.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- E. coli or S. thyphimurium TA102 were not tested
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-methylglutaronitrile
- EC Number:
- 224-923-5
- EC Name:
- 2-methylglutaronitrile
- Cas Number:
- 4553-62-2
- Molecular formula:
- C6H8N2
- IUPAC Name:
- 2-methylpentanedinitrile
- Reference substance name:
- methyl-2-glutaronitrile
- IUPAC Name:
- methyl-2-glutaronitrile
- Details on test material:
- - Name of test material (as cited in study report): Methyl Glutaronitrile
- Purity: 85 %
No other data were available
Constituent 1
Constituent 2
Method
- Target gene:
- gene of Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1537, TA1535, TA100, TA97, TA98
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 fractions of Aroclor 1254-induced males Sprague-Dawley rat and male Syrian hamsters livers (5, 10 or 30 %)
- Test concentrations with justification for top dose:
- 0; 100; 333; 1000; 3333 and 10000 µg/plate.
The appropriate dose range was evaluated in a toxicity assay with TA100. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: no data
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without S9: sodium azide (TA1535 and TA100), 9-aminoacridine (TA97 and TA1537), 4-nitro-o-phenylenediamine (TA98). With S9: 2-aminoanthracene.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation (variation of Haworth et al. protocol, 1983)
DURATION
- Incubation period: 48 hours at 37°C
NUMBER OF REPLICATIONS: triplicate.
For some conditions (some strains and some condition of metabolic activation), the test was performed twice or three times to try to confirm the results. - Evaluation criteria:
- Chemicals were judged mutagenic (+), weakly mutagenic (+W), questionable (?) or nonmutagenic (-), depending on the magnitude of the increase in
his+ revertants, and the shape of the dose-response. A trial was considered questionable if the dose-response was judged insufficiently high to
support a call of “+W”, if only a single dose was elevated over the control, or if a weak increase was not dose-related. The distinctions between a
questionable response and a nonmutagenic response, and between a weakly mutagenic response and mutagenic response are highly subjective. It
was not necessary for a response to reach two-folder over background for a trial to be judged mutagenic.
A chemical was judged mutagenic pr weakly mutagenic if it produced a reproducible, dose-related response over the solvent control, under a 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 criteria for a mutagenic or questionable response. - Statistics:
- No data
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- For the TA100, TA1535, TA1537 and TA98, the results are clearly negative with and without metabolic activation. See results in tables 7.6.1/1 to 7.6.1/4. For the TA97 strain, the author judged the results as ambigous. See results in tables 7.6.1/5 to 7.6.
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- No additional information.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 7.6.1/1:Results in terms of mutagenicity for the strain TA100.The mean of the number of revertants (triplicate) is presented for each condition. The interpretation of the publication author is written in red.
Dose (µg/plate) |
Without metabolic activation |
10%HLI |
10%RLI |
|||
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
- |
- |
- |
||||
0 |
63 |
2.5 |
89 |
11.4 |
78 |
3.6 |
100 |
78 |
7.2 |
81 |
4.7 |
88 |
6.2 |
333 |
78 |
4.2 |
82 |
7.1 |
72 |
0.3 |
1000 |
66 |
4.7 |
84 |
4.1 |
83 |
5.8 |
3333 |
81 |
3.2 |
80 |
1.2 |
71 |
12.6 |
10000 |
73 |
2.1 |
87 |
7.8 |
75 |
5.5 |
POS |
260 |
16.8 |
389 |
60.0 |
346 |
12.0 |
HLI=Aroclor 1254-induced hamster liver
HRI=Aroclor 1254-induced rat liver
POS: Positive control
?: questionable mutagenic response
-: nonmutagenic
+W: weakly mutagenic
S: slight clearing of bacterial lawn
Table 7.6.1/2:Results in terms of mutagenicity for the strain TA1535.The mean of the number of revertants (triplicate) is presented for each condition. The interpretation of the publication author is written in red.
Dose (µg/plate) |
Without metabolic activation |
10%HLI |
10%RLI |
|||
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
- |
- |
- |
||||
0 |
17 |
3.9 |
5 |
1.7 |
8 |
2.1 |
100 |
13 |
0.0 |
8 |
1.9 |
6 |
0.3 |
333 |
11 |
3.5 |
6 |
0.9 |
7 |
1.8 |
1000 |
10 |
2.6 |
8 |
1.5 |
6 |
1.5 |
3333 |
13 |
1.9 |
7 |
1.7 |
6 |
1.2 |
10000 |
15 |
2.1 |
6 |
1.2 |
7 |
0.9 |
POS |
95 |
13.9 |
39 |
1.5 |
72 |
3.0 |
HLI=Aroclor 1254-induced hamster liver
HRI=Aroclor 1254-induced rat liver
POS: Positive control
?: questionable mutagenic response
-: nonmutagenic
+W: weakly mutagenic
S: slight clearing of bacterial lawn
Table 7.6.1/3:Results in terms of mutagenicity for the strain TA1537.The mean of the number of revertants (triplicate) is presented for each condition.
Dose (µg/plate) |
Without metabolic activation |
10%HLI |
30%HLI |
10%RLI |
30%RLI |
|||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
- |
- |
- |
- |
- |
||||||
0 |
7 |
0.9 |
5 |
0.9 |
6 |
1.2 |
6 |
0.7 |
5 |
1.2 |
100 |
6 |
0.7 |
5 |
0.9 |
4 |
0.9 |
6 |
1.7 |
5 |
1.2 |
333 |
4 |
0.3 |
4 |
1.2 |
5 |
0.7 |
5 |
3.2 |
5 |
1.3 |
1000 |
4 |
1.2 |
5 |
0.6 |
3 |
0.3 |
6 |
1.2 |
6 |
3.1 |
3333 |
5 |
1.2 |
5 |
1.2 |
3 |
0.6 |
6 |
1.2 |
5 |
0.3 |
10000 |
6 |
0.3 |
2 |
0.3 |
5 |
1.2 |
3 |
0.3 |
5 |
2.1 |
POS |
23 |
1.7 |
734 |
31.7 |
1213 |
19.2 |
69 |
7.4 |
23 |
3.9 |
HLI=Aroclor 1254-induced hamster liver
HRI=Aroclor 1254-induced rat liver
POS: Positive control
?: questionable mutagenic response
-: nonmutagenic
+W: weakly mutagenic
S: slight clearing of bacterial lawn
Table 7.6.1/4:Results in terms of mutagenicity for the strain TA98.The mean of the number of revertants (triplicate) is presented for each condition. The interpretation of the publication author is written in red.
Dose (µg/plate) |
Without metabolic activation |
10%HLI |
10%RLI |
|||
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
- |
- |
- |
||||
0 |
14 |
2.9 |
26 |
4.0 |
20 |
1.2 |
100 |
13 |
1.8 |
20 |
0.9 |
17 |
1.2 |
333 |
12 |
0.9 |
18 |
4.9 |
18 |
3.2 |
1000 |
11 |
1.5 |
19 |
1.7 |
21 |
1.9 |
3333 |
12 |
1.8 |
21 |
0.9 |
18 |
2.6 |
10000 |
11 |
2.3 |
23 |
4.3 |
21 |
3.6 |
POS |
98 |
11.3 |
90 |
4.4 |
140 |
15.1 |
HLI=Aroclor 1254-induced hamster liver
HRI=Aroclor 1254-induced rat liver
POS: Positive control
?: questionable mutagenic response
-: nonmutagenic
+W: weakly mutagenic
S: slight clearing of bacterial lawn
Table 7.6.1/5:Results in terms of mutagenicity for the strain TA97 without metabolic activation. The mean of the number of revertant (triplicate) is presented for each condition. The interpretation of the publication author is written in red.3 independent experiments are presented in the table.
Dose (µg/plate) |
Experiment No.1 |
Experiment No.2 |
Experiment No.3 |
|||
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
- |
- |
- |
||||
0 |
62 |
3.6 |
72 |
4.7 |
103 |
4.7 |
100 |
51 |
8.5 |
75 |
3.8 |
112 |
10.6 |
333 |
53 |
8.0 |
73 |
4.3 |
112 |
5.5 |
1000 |
54 |
3.3 |
77 |
9.3 |
81 |
11.0 |
3333 |
55 |
2.0 |
77 |
2.1 |
87 |
11.6 |
10000 |
68 |
4.4 |
80s |
2.1 |
89 |
5.7 |
POS |
101 |
9.9 |
803 |
66.2 |
295 |
6.3 |
HLI=Aroclor 1254-induced hamster liver
HRI=Aroclor 1254-induced rat liver
POS: Positive control
?: questionable mutagenic response
-: nonmutagenic
+W: weakly mutagenic
S: slight clearing of bacterial lawn
Table 7.6.1/6:Results in terms of mutagenicity for the strain TA97 with metabolic activation (HLI). The mean of the number of revertant (triplicate) is presented for each condition. The interpretation of the publication author is written in red.Two independant experiments are presented in the table for the HLI concentrations 10 and 30%.
Dose (µg/plate) |
5%HLI |
10%HLI (Exp No. 1) |
10%HLI (Exp No. 2) |
30%HLI (Exp No. 1) |
30%HLI (Exp No. 2) |
||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
||
- |
? |
- |
+W |
+W |
|||||||
0 |
102 |
8.5 |
93 |
2.9 |
95 |
4.7 |
222 |
13.8 |
154 |
3.2 |
|
100 |
109 |
5.8 |
119 |
6.7 |
107 |
10.5 |
271 |
16.9 |
159 |
1.3 |
|
333 |
102 |
6.0 |
113 |
3.8 |
94 |
4.4 |
369 |
25.0 |
134 |
10.3 |
|
1000 |
101 |
4.3 |
114 |
6.0 |
101 |
6.1 |
378 |
6.1 |
152 |
14.6 |
|
3333 |
119 |
14.8 |
121 |
9.4 |
105 |
5.0 |
239 |
11.9 |
260 |
22.0 |
|
10000 |
106 |
6.1 |
146 |
3.4 |
110 |
8.0 |
47 |
12.4 |
256 |
33.5 |
|
POS |
1392 |
134.9 |
684 |
32.0 |
755 |
5.8 |
859 |
55.2 |
1037 |
44.7 |
|
HLI=Aroclor 1254-induced hamster liver
HRI=Aroclor 1254-induced rat liver
POS: Positive control
?: questionable mutagenic response
-: nonmutagenic
+W: weakly mutagenic
S: slight clearing of bacterial lawn
Table 7.6.1/7:Results in terms of mutagenicity for the strain TA97 with metabolic activation (RLI). The mean of the number of revertant (triplicate) is presented for each condition. The interpretation of the publication author is written in red.Several independant experiments are presented in the table for the RLI concentrations 5, 10 and 30%.
Dose (µg/plate) |
5%RLI(Exp No. 1) |
5%RLI (Exp No. 2) |
10%RLI (Exp No. 1) |
10%RLI (Exp No. 2) |
10%RLI (Exp No. 3) |
30%RLI (Exp No. 1) |
30%RLI (Exp No. 2) |
|||||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
? |
- |
- |
? |
- |
- |
- |
||||||||
0 |
208 |
21.4 |
100 |
8.5 |
99 |
8.3 |
169 |
21.1 |
158 |
4.7 |
160 |
4.8 |
174 |
7.2 |
100 |
287 |
31.9 |
103 |
5.7 |
75 |
6.8 |
176 |
17.9 |
145 |
3.8 |
126 |
22.5 |
184 |
3.2 |
333 |
295 |
40.2 |
90 |
11.7 |
76 |
5.8 |
186 |
11.8 |
139 |
15.3 |
130 |
18.4 |
179 |
6.1 |
1000 |
287 |
28.0 |
96 |
0.3 |
87 |
10.3 |
197 |
6.2 |
151 |
6.4 |
152 |
7.1 |
172 |
18.6 |
3333 |
322 |
2.6 |
98 |
0.7 |
72 |
4.8 |
206 |
50.47 |
117 |
1.7 |
159 |
2.8 |
213 |
13.3 |
10000 |
236 |
50.8 |
98 |
5.0 |
101 |
3.2 |
294 |
43.7 |
140 |
23.8 |
180 |
3.9 |
177 |
4.6 |
POS |
1517 |
18.7 |
1584 |
18.3 |
548 |
25.2 |
776 |
22.0 |
741 |
9.3 |
316 |
9.7 |
382 |
6.7 |
HLI=Aroclor 1254-induced hamster liver
HRI=Aroclor 1254-induced rat liver
POS: Positive control
?: questionable mutagenic response
-: nonmutagenic
+W: weakly mutagenic
S: slight clearing of bacterial lawn
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the test conditions, Methylglutaronitrile is not mutagenic in bacteria. - Executive summary:
In a reverse gene mutation assay in bacteria (Zeiger et al., 1988) performed similarly to the OECD test guideline No. 471, strains TA 1535, TA 1537, TA 97, TA 98 and TA 100 of S. typhimurium were exposed to methylglutaronitrile (85%) in DMSO at concentrations of 0; 100; 333; 1000; 3333 and 10000 µg/plate. Tests were conducted in the presence and absence of mammalian metabolic activation (S-9 fractions of Aroclor 1254-induced males Sprague-Dawley rat and male Syrian hamsters livers (5, 10 or 30 %)).
The positive controls induced the appropriate responses in the corresponding strains.
Methylglutaronitrile was tested up to limit concentration (10 mg/plate) recommended in the OECD guideline No. 471 and no significant cytotoxicity was observed.
For the TA100, TA1535, TA1537 and TA98, the results are clearly negative with and without metabolic activation. For the TA97 strain, the author judged the results as ambigous. However, the number of revertants with the test item for the TA 97 strain with and without metabolic activation did never exceed twice the number of revertants obtained with the vehicule control. Therefore, when the number of revertants with the test item increased, this increase can not be considered as significant (expert judgement).
Under the test conditions, Methylglutaronitrile is not considered as mutagenic in bacteria.
This study is considered as acceptable as the main criteria of the OECD guideline No. 471.
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