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EC number: 700-316-5 | CAS number: 1155405-88-1
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from 1998-08-10 to 1998-08-28
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tri (hexyl, octyl, decyl) citrate
- IUPAC Name:
- Tri (hexyl, octyl, decyl) citrate
- Reference substance name:
- 2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester
- IUPAC Name:
- 2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester
- Reference substance name:
- -
- EC Number:
- 430-290-8
- EC Name:
- -
- IUPAC Name:
- 430-290-8
- Details on test material:
- - Name of test material (as cited in study report): Tri (hexyl, octyl, decyl) citrate
- Substance type: pure active substance
- Physical state: liquid
- Storage condition of test material: room temperature in a closed container
Constituent 1
Constituent 2
Constituent 3
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital (80 mg/kg bw) and ß-Naphtoflavone (100 mg/kg bw) induced S9 liver microsomal fraction of male Wistar rats
- Test concentrations with justification for top dose:
- 33.3 / 100.0 / 333.3 / 1000.0 / 2500.0 / 5000.0 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and the S9 activity.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide, 10 µg/plate for S. typhimurium strains TA 1535, TA 100; 4-nitro-o-phenylene-diamine, 10 µg/plate for S. typhimurium strain TA 98 and 40 µg/plate for S. typhimurium strain TA 1537; methyl methane sulfonate, 1 µL/plate for E. coli strain WP2 u
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 2.5 µg/plate for all strains
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation in two independent experiments
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 hours at least
NUMBER OF REPLICATIONS: For each strain and dose level, including the controls, three plates were used.
DETERMINATION OF CYTOTOXICITY
- Method: detected by a reduction in the number of revertants, a clearing of diminution of tht background lawn or by the degree of survival of treated cultures
OTHER EXAMINATIONS:
- Data recording: The colonies were counted using an Artek-counter Modell 880 ( Artek Systems Corpoporation, BIOSYS GmbH, Karben, Germany) at maximum sensitivity. If precipitation of test item precluded automatic counting the revertant colonies were counted by hand.
OTHER: The properties of the S. typhimurium and E. coli strains with regard to membrane permeability, ampicillin resistance and normal spontaneous mutation rates were checked regularly to Ames et al. - Evaluation criteria:
- A test was considered acceptable if for each strain:
- the bacteria demonstrate their typical responses to crystal violet and ampicillin
- the control plates without S9 mix were within the range of spontaneous reversion frequencies
- corresponding background growth on both negative control and test plates was observed
- the positive controls showed a distinct enhancement over the control plates
A test item was considered as mutagenic if a dose-related increase in the number of revertants occured and/or a reproducible biologically relevant positive response for at least one the test points occured in at least one strain with or without metabolic activation.
A biologically relevant increase was described as:
- if in strain TA 100 the number of reversions was at least twice as high
- if in strains TA 1535, TA 1537, TA 98 and WP2 uvr A was at least three times higher
than the spontaneous reversion rate.
Also, a dose-dependent and reproducible increase in the number of revertants was regarded as an indication of possible existing mutagenic potential of the test item regardless of whether the highest dose induced the above described enhancement factors or not. - Statistics:
- no statistical evaluation performed
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: not applicable
- Water solubility: no data
- Precipitation: nothing mentioned
- Other confounding effects: none
RANGE-FINDING/SCREENING STUDIES: Yes, performed using the same experimental conditions as described for the plate incorporation test to detemine the toxicity of the test item. 8 concentrations were tested for toxicity and induction of mutations with 3 plated each. No toxicity or genotoxicity was observed.
COMPARISON WITH HISTORICAL CONTROL DATA: nothing mentioned
ADDITIONAL INFORMATION TO CYTOTOXICITY: Normal background growth was observed up to the highest concentration of the test item with and without metabolic activation in all stains used. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table #1:Number of revertants per plate (mean of 3 plates) of the plate incorporation test
|
[Strain TA 1535] |
[Strain TA 1537] |
[Strain TA 98] |
||||||
Conc. |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
0* |
12±2 |
9±2 |
- |
11±1 |
7±3 |
- |
40±7 |
59±21 |
- |
33.3 |
10±2 |
8±3 |
no |
8±3 |
9±2 |
no |
59±3 |
64±8 |
no |
100.0 |
11±1 |
10±2 |
no |
10±4 |
6±2 |
no |
57±12 |
65±10 |
no |
333.3 |
10±3 |
9±3 |
no |
15±8 |
9±2 |
no |
47±2 |
67±6 |
no |
1000.0 |
11±5 |
11±1 |
no |
11±4 |
7±2 |
no |
38±10 |
67±14 |
no |
2500.0 |
11±6 |
8±4 |
no |
8±2 |
4±1 |
no |
62±7 |
67±4 |
no |
5000.0 |
9±1 |
7±1 |
no |
9±4 |
6±2 |
no |
42±5 |
69±9 |
no |
Positive control |
1258±101 |
212±16 |
- |
224±16 |
225±18 |
- |
1090±34 |
247±151 |
- |
*solvent control with DMSO
Table #2:Number of revertants per plate (mean of 3 plates) of the plate incorporation test
|
[Strain TA 100] |
[Strain WP2 uvrA] |
|||||||
Conc. |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
0* |
125±17 |
118±13 |
- |
33±7 |
60±9 |
- |
|
|
|
33.3 |
119±10 |
123±12 |
no |
42±19 |
49±2 |
no |
|
|
|
100.0 |
123±9 |
124±8 |
no |
37±12 |
59±3 |
no |
|
|
|
333.3 |
130±4 |
125±18 |
no |
38±8 |
52±6 |
no |
|
|
|
1000.0 |
135±9 |
138±12 |
no |
42±7 |
58±11 |
no |
|
|
|
2500.0 |
134±10 |
128±3 |
no |
39±6 |
66±10 |
no |
|
|
|
5000.0 |
146±12 |
122±10 |
no |
36±3 |
54±7 |
no |
|
|
|
Positive control |
1321±8 |
2315±155 |
- |
807±47 |
769±21 |
- |
*solvent control with DMSO
Table #3:Number of revertants per plate (mean of 3 plates) of the preincubation test
|
[Strain TA 1535] |
[Strain TA 1537] |
[Strain TA 98] |
||||||
Conc. |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
0* |
16±4 |
13±2 |
- |
11±2 |
10±2 |
- |
37±3 |
50±5 |
- |
33.3 |
15±5 |
11±4 |
no |
13±2 |
11±2 |
no |
51±7 |
51±2 |
no |
100.0 |
11±4 |
12±3 |
no |
14±5 |
10±1 |
no |
49±2 |
64±6 |
no |
333.3 |
17±1 |
14±2 |
no |
13±3 |
12±4 |
no |
50±4 |
60±13 |
no |
1000.0 |
15±1 |
12±2 |
no |
17±4 |
10±3 |
no |
39±6 |
52±5 |
no |
2500.0 |
17±9 |
11±4 |
no |
8±3 |
8±1 |
no |
33±6 |
50±12 |
no |
5000.0 |
13±8 |
14±5 |
no |
14±3 |
10±4 |
no |
44±10 |
60±14 |
no |
Positive control |
1044±14 |
143±5 |
- |
298±11 |
135±17 |
- |
1163±58 |
1128±82 |
- |
*solvent control with DMSO
Table #4:Number of revertants per plate (mean of 3 plates) of the preincubation test
|
[Strain TA 100] |
[Strain WP2uvrA] |
|||||||
Conc. |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
¿ MA |
+ MA |
Cytotoxic |
0* |
101±17 |
113±12 |
- |
27±4 |
50±8 |
- |
|
|
|
33.3 |
90±10 |
110±8 |
no |
31±8 |
33±7 |
no |
|
|
|
100.0 |
84±6 |
108±18 |
no |
31±1 |
33±5 |
no |
|
|
|
333.3 |
99±23 |
94±4 |
no |
36±5 |
37±4 |
no |
|
|
|
1000.0 |
99±7 |
104±10 |
no |
27±5 |
36±2 |
no |
|
|
|
2500.0 |
115±8 |
115±6 |
no |
32±5 |
39±2 |
no |
|
|
|
5000.0 |
144±30 |
98±13 |
no |
30±9 |
41±15 |
no |
|
|
|
Positive control |
1335±103 |
1198±118 |
- |
210±28 |
223±2 |
- |
*solvent control with DMSO
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The reported data of this mutagenicity test showed that the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, Tri (hexyl, octyl, decyl) citrate was considered to be non-mutagenic in this bacterial reverse mutation assay.
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