Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 904-797-4 | CAS number: -
- 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:
- 1982- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, GLP-compliant, available as unpublished report, no restrictions, adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Ames, B. N., McCann, J., and Yamasaki, E. (1975). Methods for Detecting Carcinogens and Mutagens with the Salmonella Mammalian-Microsome Test. Mutat. Res. 31, 347-364.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: MRC's standard operating procedure for Salmonella typhimurium (Document #B002R3).
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Terphenyl
- EC Number:
- 247-477-3
- EC Name:
- Terphenyl
- Cas Number:
- 26140-60-3
- Molecular formula:
- C18H14
- IUPAC Name:
- terphenyl
- Details on test material:
- - Name of test material: toluol soluble terphenyl and quarterphenyls
- Substance type: mixed-terphenyls, -quaterphenyls
- Physical state: solid
- Storage condition of test material: test materials were stored in the dark at refrigeration temperature prior to testing.
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- 0.01, 0.04, 0.2, 1.0, 3.0, 10.0 mg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the test material is not soluble in water, partially soluble in ethanol, soluble in DMSO
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 100 µL of solvent per plate
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA1535, TA1537; with metabolic activation
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537; without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- TA98, TA100; with metabolic activation
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA98, TA100; without metabolic activation
- Positive controls:
- yes
- Positive control substance:
- other: sodium nitrite
- Remarks:
- TA1535; without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: Plates were incubated at 37°C (±1°C) for 48 hours
NUMBER OF REPLICATIONS: Three replicate plates for each strain/microsome/dose level combination
DETERMINATION OF CYTOTOXICITY
- Method: results indicating any effect on the growth of background lawns or any detectable plating interferences - Statistics:
- Analysis included Bartlett's test for homogeneity of variance and comparison of treatments with controls uing within-levels pooled variance and a one-sided t-test.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- between 10-0.04 mg
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: not soluble in water
- Precipitation: sample precipitates out on plates at 10, 3 and 1 mg/plate
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the toxicity screen, a concentration of > or = 1mg of sample per plate expressed a slight level of toxicity in the presence and absence of microsomal activation.
Any other information on results incl. tables
The plate incorporation assay: Summary
With microsomal activation |
||||||||||||
Amount/plate (mg) |
Revertants/plate |
|||||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
|||||||||
10.0 |
42 |
32 |
40 |
138 |
170 |
128 |
10 |
10 |
10 |
9 |
7 |
6 |
3.0 |
50 |
35 |
35 |
124 |
154 |
144 |
10 |
7 |
8 |
3 |
6 |
6 |
1.0 |
37 |
49 |
43 |
107 |
128 |
124 |
12 |
18 |
14 |
7 |
6 |
5 |
0.2 |
46 |
34 |
38 |
128 |
123 |
133 |
16 |
8 |
13 |
10 |
2 |
6 |
0.04 |
45 |
47 |
38 |
132 |
126 |
125 |
16 |
9 |
14 |
8 |
7 |
10 |
0.01 |
41 |
35 |
33 |
99 |
99 |
81 |
5 |
15 |
8 |
5 |
10 |
4 |
Controls |
||||||||||||
Solvent |
29 |
39 |
38 |
119 |
84 |
81 |
14 |
10 |
12 |
10 |
11 |
11 |
Negative |
45 |
|
|
75 |
|
|
6 |
|
|
8 |
|
|
Positive |
|
861 |
|
|
1159 |
|
|
280 |
|
|
342 |
|
Without microsomal activation |
||||||||||||
Amount/plate (mg) |
Revertants/plate |
|||||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
|||||||||
10.0 |
25 |
28 |
28 |
97 |
74 |
73 |
12 |
4 |
12 |
8 |
5 |
4 |
3.0 |
27 |
20 |
34 |
77 |
83 |
86 |
5 |
11 |
9 |
5 |
5 |
7 |
1.0 |
25 |
29 |
31 |
69 |
60 |
93 |
12 |
7 |
11 |
8 |
6 |
4 |
0.2 |
27 |
24 |
30 |
97 |
50 |
58 |
8 |
9 |
6 |
12 |
10 |
5 |
0.04 |
27 |
29 |
35 |
78 |
74 |
61 |
11 |
16 |
6 |
12 |
9 |
4 |
0.01 |
28 |
30 |
26 |
74 |
77 |
68 |
7 |
5 |
6 |
7 |
6 |
7 |
Controls |
||||||||||||
Solvent |
29 |
27 |
29 |
89 |
63 |
79 |
8 |
8 |
7 |
11 |
19 |
8 |
Negative |
28 |
|
|
91 |
|
|
14 |
|
|
8 |
|
|
Positive |
|
667 |
|
|
1174 |
|
|
535 |
|
|
1564 |
|
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: equivocal (overall result).
Individual results: negative without metabolic activation for TA98, TA100, TA1535 and TA1537; negative with metabolic activation for strain TA98, TA1535 and TA 1537; positive with metabolic activation only for strain TA100
The Ames test indicated that there was no activation without metabolic activation. With metabolic activation, one strain showed positive results (TA100) while all other strains were negative. However, this single positive result in TA100 has to be judged carefully when taking a closer look at the mean values of the plates of TA100+S9: 93/ 128 / 128 / 120 / 141 / 145 revertants per plate (solvent: 95 revertants/plate). As such, the test item showed only a slight increase by a factor of 1.5 which can not clearly be judged as biologically relevant (an increase of more than 12 times was found for the positive control). A report of the U.S. Environmental Protection Agency Gene-Tox-Program (Kier et al., 1986, [1]) points out that a biologically relevant increase in tester strain TA100 requires the number of reversions to be at least twice as high. As such, taking into account the information given in the guidance on the application of the CLP criteria and in the publication of Kier et. al, 1986, the obtained results do not allow for a clear derivation of a positive result and are considered as equivocal and questionable.
[1] Kier, L.E., Brusick, D.J., Auletta, A.E., von Halle, E.S., Brown, M.M., Simmon, V.F., Dunkel, V., McCann, J., Mortelmans, K., Prival, M., Rao, T.K. and Ray, V. (1986), The Salmonella typhimurium/mammalian microsomal assay. A report of the U.S. Environmental Protection Agency Gene-Tox–Program, Mutat. Res. 168, 69-240 - Executive summary:
Mixture of terphenyls and quarterphenyls was not mutagenic with and without metabolic activation in Salmonella strains TA98, TA1535 and TA1537. The Mixture of terphenyls and quarterphenyls was not mutagenic without metabolic activation in Salmonella strain TA100. The experiments with the Mixture of terphenyls and quarterphenyls with metabolic activation revealed equivocal results in Salmonella strain TA100. A slight increase of the number of revertants per plate (factor of 1.5) was observed. However, this single positive result in TA100 has to be judged carefully when taking a closer look at the mean values of the plates of TA100+S9: 93/ 128 / 128 / 120 / 141 / 145 revertants per plate (solvent: 95 revertants/plate). As such, the Mixture of terphenyls and quarterphenyls showed only a slight increase by a factor of 1.5 which can not clearly be judged as biologically relevant (an increase of more than 12 times was found for the positive control). A report of the U.S. Environmental Protection Agency Gene-Tox-Program (Kier et al., 1986, [1]) points out that a biologically relevant increase in tester strain TA100 requires the number of reversions to be at least twice as high. As such, taking into account the information given in the guidance on the application of the CLP criteria, the obtained results do not allow for a clear derivation of a positive result and are considered as equivocal and questionable.
[1] Kier, L.E., Brusick, D.J., Auletta, A.E., von Halle, E.S., Brown, M.M., Simmon, V.F., Dunkel, V., McCann, J., Mortelmans, K., Prival, M., Rao, T.K. and Ray, V. (1986), The Salmonella typhimurium/mammalian microsomal assay. A report of the U.S. Environmental Protection Agency Gene-Tox–Program, Mutat. Res. 168, 69-240
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.