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EC number: 617-638-6 | CAS number: 84868-02-0
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07-05-1991 to 03-06-1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (1's,4'r)-4'-pentyl-[1,1'-bi(cyclohexane)]-4-one
- EC Number:
- 617-638-6
- Cas Number:
- 84868-02-0
- Molecular formula:
- C17H30O
- IUPAC Name:
- (1's,4'r)-4'-pentyl-[1,1'-bi(cyclohexane)]-4-one
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- TA 100 (his G 46, uvrB, rfa + R-factor)
TA 1535 (his G 46, uvrB, rfa)
TA 98 (his D 3052, uvrB, rfa + R-factor)
TA 1537 (his C 3076, uvrB, rfa)
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- TA 1538 (his D 3052, uvrB, rfa)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 metabolizing system (S-9 mix)
Preparation of liver homogenate fraction (S-9)
S-9 is routinely prepared, following the proposals of AMES et al. (1975). It is kept at about -196 °C. Male Chbb:Thom (Wistar) rats (aged 6 - 8 weeks) are given a single intraperitoneal injection of Aroclor 1254 (500 mg/kg body weight) diluted in Miglyol 812 oil. The animals receive drinking water and Altromin standard diet ad libitum. About 16 hours before sacrifice, the feed is removed. On day 5 the rats are sacrificed and the livers collected in ice-cooled sterilized beakers containing 0.15 M KCl. The livers are homogenized in a sterile glass potter homogenizer containing 3 mL of 0.15 M KCl per each gram of liver wet-weight. The homogenate is spun at 9000xg for 15 minutes at about +4 °C and the supernatant fluid is decanted and transferred into sterilized and precooled plastic tubes. The S-9 is then frozen in liquid nitrogen and stored at -196 °C. The protein content of the S-9 preparation is determined by the biuret method. - Test concentrations with justification for top dose:
- Concentrations in the range-finding test: 50, 250, 500, 1000, 2000, 3000, 4000, 5000, 7500, 10000 µg/plate
Concentrations in Experiment 1: 50, 250, 1250, 2500, 5000, 10000 µg/plate
In a range-finding test (using S.typh. TA 100 and TA 1535 without metabolic activation) toxicity was investigated in a wide range of test material concentrations (50 - 10000 µg/plate). Toxicity normally becomes evident by a reduction in the number of spontaneous revertants, a clearing of the background lawn, or by reduced survival of treated cultures. These effects were not observed with the test item in the range-finding test. Precipitation of the test material did not interfere with the bacterial growth. Therefore, 6 different amounts of the test material up to 10000 µg/plate were used in each of the two series of experiments. - Vehicle / solvent:
- - Solvent: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylene diamine 4-NP, daunomycin DAUN, 1-ethyl-2-nitro-3-nitrosoguanidine ENNG
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: 8
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 hours
- Incubation temperature: 37 °C
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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The results of both series of experiments, each performed with and without the addition of rat liver microsomal fraction as external metabolizing system, were negative. Under the test conditions used, the test item was not mutagenic in Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, and TA 1538. The negative control mutant frequencies were all in the regular range, and the positive control compounds yielded the expected mutant frequencies that were greatly in excess of the background.
Any other information on results incl. tables
Table 1: Number of revertants per plate (mean of four plates), Experiment 1
strain TA 100 |
strain TA 1535 |
strain TA 1537 |
strain TA 1538 |
strain TA 98 |
||||||
conc. [µg] per plate |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
0 |
148 |
163 |
10 |
18 |
6 |
8 |
8 |
12 |
21 |
30 |
50 |
138 |
191 |
9 |
13 |
6 |
6 |
6 |
11 |
21 |
31 |
250 |
144 |
176 |
9 |
13 |
5 |
5 |
7 |
12 |
15 |
28 |
1250 |
139 |
151 |
9 |
14 |
6 |
8 |
6 |
8 |
18 |
25 |
2500 |
154 |
167 |
8 |
15 |
5 |
5 |
6 |
9 |
17 |
27 |
5000 |
153 |
164 |
8 |
12 |
4 |
6 |
8 |
9 |
18 |
29 |
10000 |
139 |
163 |
11 |
11 |
5 |
5 |
6 |
8 |
17 |
27 |
0 |
135 |
174 |
11 |
16 |
7 |
8 |
8 |
12 |
25 |
26 |
NaN3 (1 µg/pl) |
|
|
622 |
|
|
|
|
|
|
|
DAUN (2 µg/pl) |
|
|
|
|
|
|
|
|
497 |
|
2-NF (2 µg/pl) |
|
|
|
|
|
|
|
|
301 |
|
2-NF (5 µg/pl) |
|
|
|
|
|
|
5 |
|
|
|
2-AA (1 µg/pl) |
157 |
576 |
8 |
139 |
5 |
60 |
7 |
454 |
19 |
452 |
Ve-H2O |
|
|
15 |
|
|
|
|
|
20 |
|
MMS (500 µg/pl) |
1157 |
|
|
|
|
|
|
|
|
|
ENNG (4 µg/pl) |
929 |
|
423 |
|
|
|
|
|
|
|
Etanol EtOH |
|
|
|
|
6 |
|
|
|
|
|
9-AA (20 µg/pl) |
|
|
|
|
30 |
|
|
|
|
|
9-AA (50 µg/pl) |
|
|
|
|
283 |
|
|
|
|
|
4-NP (10 µg/pl) |
|
|
|
|
|
|
1026 |
|
|
|
NaN3: Sodium azide, DAUN: Daunomycin, 2-NF: 2-Nitrofluorene, 2-AA: 2-Aminoanthracene, Ve-H2O: deionized water, MMS: methylmethanesulfonate, ENNG: 1-ethyl-2-nitro-3-nitrosoguanidine, 9-AA: 9-Aminoacridine, 4-NP: 4-nitro-1,2-phenylene diamine
Table 2: Number of revertants per plate (mean of four plates), Experiment 2
strain TA 100 |
strain TA 1535 |
Strain TA 1537 |
strain TA 1538 |
strain TA 98 |
||||||
conc. [µg] |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
0 |
156 |
178 |
8 |
15 |
5 |
5 |
6 |
12 |
17 |
18 |
50 |
145 |
170 |
8 |
11 |
5 |
5 |
4 |
7 |
13 |
25 |
250 |
144 |
181 |
6 |
13 |
4 |
5 |
6 |
9 |
13 |
25 |
1250 |
161 |
173 |
6 |
12 |
4 |
7 |
5 |
8 |
15 |
20 |
2500 |
142 |
165 |
7 |
11 |
4 |
4 |
6 |
10 |
16 |
23 |
5000 |
145 |
164 |
7 |
11 |
3 |
4 |
4 |
8 |
14 |
19 |
10000 |
140 |
167 |
5 |
10 |
4 |
3 |
3 |
9 |
14 |
19 |
0 |
156 |
167 |
9 |
13 |
5 |
6 |
6 |
14 |
15 |
28 |
NaN3 (1 µg/pl) |
|
|
388 |
|
|
|
|
|
|
|
DAUN (2 µg/pl) |
|
|
|
|
|
|
|
|
659 |
|
2-NF (2 µg/pl) |
|
|
|
|
|
|
|
|
301 |
|
2-NF (5 µg/pl) |
|
|
|
|
|
|
744 |
|
|
|
2-AA (1 µg/pl) |
148 |
640 |
8 |
136 |
4 |
53 |
5 |
429 |
16 |
381 |
Ve-H2O |
|
|
8 |
|
|
|
|
|
20 |
|
MMS (500 µg/pl) |
966 |
|
|
|
|
|
|
|
|
|
ENNG (4 µg/pl) |
880 |
|
554 |
|
|
|
|
|
|
|
Etanol EtOH |
|
|
|
|
5 |
|
|
|
|
|
9-AA (20 µg/pl) |
|
|
|
|
22 |
|
|
|
|
|
9-AA (50 µg/pl) |
|
|
|
|
267 |
|
|
|
|
|
4-NP (10 µg/pl) |
|
|
|
|
|
|
855 |
|
|
|
NaN3: Sodium azide, DAUN: Daunomycin, 2-NF: 2-Nitrofluorene, 2-AA: 2-Aminoanthracene, Ve-H2O: deionized water, MMS: methylmethanesulfonate, ENNG: 1-ethyl-2-nitro-3-nitrosoguanidine, 9-AA: 9-Aminoacridine, 4-NP: 4-nitro-1,2-phenylene diamine
Applicant's summary and conclusion
- Conclusions:
- During the experiments there was no evidence of toxicity to the bacteria caused by the test material exposure. The test material is considered to be non-mutagenic.
- Executive summary:
The investigations for mutagenic potential were performed using Salmonella typhimurium TA 100, TA 98, TA 1535, TA 1537, and TA 1538 as tester strains according to OECD 471. The plate incorporation test with and without addition of rat liver S-9 fraction (Aroclor-induced) was used. The test item was tested in two series of experiments at the following concentrations: 50, 250, 1250, 2500, 5000, and 10000 µg/plate. 9-Aminoacridine, daunomycin, 1-ethyl-2-nitro-3-nitrosoguanidine, methyl methanesulfonate, 2-nitro-fluorene, 4-nitro-l,2-phenylene diamine and sodium azide served as positive control compounds for testing the bacteria. 2-Aminoanthracene was used for testing the bacteria and the activity of the S-9 preparation. The positive controls showed normal reversion properties of all strains and good metabolic activity of the S-9 mix used. No test material precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix. During the experiments there was no evidence of toxicity to the bacteria caused by the test material exposure. Under the conditions described, there were no relevant increases in revertant numbers after treatment with the test item observed in both, the absence and presence of S9 mix. In conclusion, the test material was considered to be non-mutagenic under the described experimental conditions.
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