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EC number: 201-240-0 | CAS number: 79-97-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 Jan - 09 Mar 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: The guideline of the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Kanpogyo No. 700, Yakuhatsu No. 1039, 61 Kikyoku No. 1014, 1986)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4,4'-isopropylidenedi-o-cresol
- EC Number:
- 201-240-0
- EC Name:
- 4,4'-isopropylidenedi-o-cresol
- Cas Number:
- 79-97-0
- Molecular formula:
- C17H20O2
- IUPAC Name:
- 4,4'-isopropylidenedi-o-cresol
Constituent 1
Method
- Target gene:
- his operon; trp operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- First experiment: 50, 100, 500, 1000, 2000 and 5000 µg/plate with and without metabolic activation
Second experiment: 15.6, 31.3, 62.5, 125, 250, 500 and 1000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Solvent used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- furylfuramide
- other: 2-Aminoanthracene: +S9: 2 or 20 µg/plate for TA1535 and WP2uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: Duplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: Reduction of bacterial growth - Evaluation criteria:
- From these results, the mutagenicity of the test substance was evaluated as negative:
- The number of colonies with reverse mutation of test bacterial strains induced by the test substance was within the range of naturally induced reverse mutation found in the bacterial strains of each test.
- The test substance showed antibacterial activity against the test bacterial strains.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I: ≥ 500 µg/plate with and without metabolic activation; Experiment II: ≥ 500 µg/plate without metabolic activation and ≥ 250 µg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I: ≥ 500 µg/plate with and without metabolic activation; Experiment II: ≥ 250 µg/plate with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I: ≥ 500 µg/plate with and without metabolic activation; Experiment II: ≥ 250 µg/plate without metabolic activation and ≥ 500 µg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I: ≥ 500 µg/plate with and without metabolic activation; Experiment II: ≥ 250 µg/plate without metabolic activation and ≥ 500 µg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Experiment I: ≥ 500 µg/plate with and without metabolic activation; Experiment II: ≥ 500 µg/plate without metabolic activation and at 1000 µg/plate with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Results of Experiment I
Presence of metabolic activation system |
Concentration of test substance (μg/plate) |
Number of reverse mutation (colonies/plate) |
|||||
Base substitution |
Frameshift type |
||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||
- S9 |
Solvent control |
159 174 (167) |
9 11 (10) |
24 17 (21) |
20 26 (23) |
10 10 (10) |
|
50 |
187 149 (168) |
11 16 (14) |
29 21 (25) |
23 16 (20) |
9 9 (9) |
||
100 |
152 146 (149) |
17 11 (14) |
28 18 (23) |
20 12 (16) |
7 4 (6) |
||
500 |
0* |
0* |
10 15 (13)* |
1 0 (1)* |
0* |
||
1000 |
0* |
0* |
0* |
0* |
0* |
||
2000 |
0* |
0* |
0* |
0* |
0* |
||
5000 |
0*C |
0*C |
0*C |
0*C |
0*C |
||
+ S9 |
Solvent control |
163 212 (188) |
16 15 (16) |
26 24 (25) |
33 37 (35) |
13 5 (9) |
|
50 |
209 192 (201) |
18 13 (16) |
37 28 (33) |
37 48 (43) |
9 8 (9) |
||
100 |
178 166 (172) |
17 26 (22) |
21 15 (18) |
41 55 (48) |
7 6 (7) |
||
500 |
79 65 (72)* |
9 7 (8)* |
16 19 (18)* |
32 9 (21)* |
0* |
||
1000 |
7 12 (10)* |
3 1 (2)* |
5 6 (6)* |
0* |
0* |
||
2000 |
0* |
0* |
0* |
0* |
0* |
||
5000 |
0*C |
0*C |
0*C |
0*C |
0*C |
||
Positive control |
- S9 |
Name |
AF-2 |
SA |
ENNG |
AF-2 |
9-AA |
Concentration (μg/plate) |
0.01 |
0.5 |
2 |
0.1 |
80 |
||
Colonies/plate |
606 543 (575) |
294 284 (289) |
669 653 (661) |
344 354 (349) |
423 565 (497) |
||
+ S9 |
Name |
BP |
2-AA |
2-AA |
BP |
BP |
|
Concentration (μg/plate) |
5 |
2 |
20 |
5 |
5 |
||
Colonies/plate |
1105 1155 (1130) |
169 210 (190) |
999 1062 (1031) |
413 421 (417) |
174 214 (194) |
||
( ): The mean colony number is given in parentheses
*: Bacterial growth suppression was observed
C: Precipitation (crystals) was observed
AF-2: 2-(2-furyl)-3-(5-nitro-2-furyl) acrylamide (furfurylamide)
SA: Sodium azide
ENNG: N-ethyl-N-nitroso-N’-nitroguanidine (ENNG)
9-AA: 9-Aminoacridine
BP: Benzo[a]pyrene
2-AA: 2-Aminoanthracene
Table 2: Results of Experiment II
Presence of metabolic activation system |
Concentration of test substance (μg/plate) |
Number of reverse mutation (colonies/plate) |
|||||
Base substitution |
Frameshift type |
||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||
- S9 |
Solvent control |
143 176 (160) |
13 9 (11) |
23 13 (18) |
33 23 (28) |
8 7 (8) |
|
15.6 |
161 146 (154) |
10 14 (12) |
22 18 (20) |
23 13 (18) |
6 3 (5) |
||
31.3 |
138 167 (153) |
15 17 (16) |
11 21 (16) |
22 12 (17) |
5 10 (8) |
||
62.5 |
175 148 (162) |
21 13 (17) |
14 12 (13) |
24 25 (25) |
11 5 (8) |
||
125 |
148 162 (155) |
16 11 (14) |
9 18 (14) |
16 21 (19) |
5 4 (5) |
||
250 |
38 10 (24)* |
11 13 (12) |
16 13 (15) |
12 9 (11)* |
0* |
||
500 |
0* |
2 2 (2)* |
4 5 (5)* |
0* |
0* |
||
1000 |
|
|
0* |
|
|
||
+ S9 |
Solvent control |
185 139 (162) |
19 15 (17) |
25 18 (22) |
48 46 (47) |
7 11 (9) |
|
15.6 |
190 157 (174) |
11 13 (12) |
17 16 (22) |
45 60 (53) |
9 6 (8) |
||
31.3 |
164 162 (163) |
16 16 (16) |
16 17 (17) |
49 45 (47) |
13 20 (17) |
||
62.5 |
176 171 (174) |
17 20 (19) |
17 28 (23) |
62 54 (58) |
9 15 (12) |
||
125 |
176 195 (186) |
20 16 (18) |
22 20 (21) |
57 54 (56) |
5 13 (9) |
||
250 |
165 131 (148) |
0* |
20 21 (21) |
34 37 (36) |
10 14 (12)* |
||
500 |
69 85 (77)* |
0* |
10 17 (14) |
32 31 (32)* |
0* |
||
1000 |
|
|
7 2 (5)* |
|
|
||
Positive control |
- S9 |
Name |
AF-2 |
SA |
ENNG |
AF-2 |
9-AA |
Concentration (μg/plate) |
0.01 |
0.5 |
2 |
0.1 |
80 |
||
Colonies/plate |
516 597 (557) |
204 188 (196) |
239 296 (268) |
320 393 (357) |
780 432 (606) |
||
+ S9 |
Name |
BP |
2-AA |
2-AA |
BP |
BP |
|
Concentration (μg/plate) |
5 |
2 |
20 |
5 |
5 |
||
Colonies/plate |
1357 1371 (1364) |
318 354 (336) |
1286 1229 (1258) |
367 447 (407) |
215 210 (213) |
||
( ): The mean colony number is given in parentheses
*: Bacterial growth suppression was observed
C: Precipitation (crystals) was observed
AF-2: 2-(2-furyl)-3-(5-nitro-2-furyl) acrylamide (furfurylamide)
SA: Sodium azide
ENNG: N-ethyl-N-nitroso-N’-nitroguanidine (ENNG)
9-AA: 9-Aminoacridine
BP: Benzo[a]pyrene
2-AA: 2-Aminoanthracene
Applicant's summary and conclusion
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.
