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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 306-248-9 | CAS number: 96690-53-8
- 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:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sunflower oil, ester with sorbitol
- EC Number:
- 306-248-9
- EC Name:
- Sunflower oil, ester with sorbitol
- Cas Number:
- 96690-53-8
- IUPAC Name:
- sunflower seed oil sorbitol esters
- Test material form:
- liquid
- Details on test material:
- Batch Number: P08/002
Expiry Date: 2010-03-01
Stability of Polyethyleneglycol: stable for hours
Constituent 1
Method
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:
- Phenobarbital/ß-Naphtholflavone induced rat liver S9
- Test concentrations with justification for top dose:
- In preliminary cytoxicity test, no significant cytotoxicity was found. Therefore the main studies (Exp I and Exp II) were performed up to the dose of 5000 µg/plate.
- Vehicle / solvent:
- DMSO was used
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: see the additional information
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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table: Summary of Results_Experiment I |
|||||||
|
|||||||
Metabolic Activation |
Test Group |
Dose Level (µg/plate) |
Revertant Colony Counts (Mean ±SD)
|
||||
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|||||||
Without metabolic Activation |
DMSO |
|
22 ± 2B M |
14 ± 2 |
27 ± 4 |
114 ± 15 |
45 ± 6 |
Untreated |
|
23 ± 5B M |
10 ± 3 |
36 ± 3 |
115 ± 13 |
47 ± 1 |
|
Hostacerin SFO |
3µg |
24 ± 1B M S |
14 ± 5 |
32 ± 9 |
114 ± 14 |
44 ± 5 |
|
10µg |
21 ± 4B M |
11 ± 2 |
31 ± 3 |
112 ± 7 |
47 ± 9 |
||
33µg |
20 ± 4B M |
12 ± 4 |
34 ± 6 |
112 ± 7 |
43 ± 7 |
||
100µg |
20 ± 5B M |
8 ± 2 |
33 ± 7 |
113 ± 7 |
45 ± 7 |
||
333µg |
22 ± 4B M |
11 ± 2 |
35 ± 7 |
110 ± 8 |
41 ± 4 |
||
1000µg |
18 ± 3P B M |
9 ± 2P |
32 ± 3P |
108 ± 7P |
38 ± 3P |
||
2500µg |
17 ± 5P B M |
11 ± 3P |
30 ± 0P |
109 ± 10P |
50 ± 2P |
||
5000µg |
14 ± 2P B M |
12 ± 3P |
25 ± 1P M |
113 ± 7P |
38 ± 6P M |
||
NaN3 |
10 µg |
3126 ± 67 |
|
|
2708 ± 167 |
|
|
4-NOPD |
10 µg |
|
|
516 ± 22 |
|
|
|
4-NOPD |
50 µg |
|
99 ± 6 |
|
|
|
|
MMS |
3.0 µg |
|
|
|
|
917 ± 65 |
|
|
|||||||
With metabolic activation |
DMSO |
|
26 ± 3B M |
25 ± 5 |
47 ± 3 |
104 ± 7 |
66 ± 12 |
Untreated |
|
28 ± 3B M |
27 ± 1 |
43 ± 4 |
118 ± 10 |
50 ± 9 |
|
Hostacerin SFO |
3µg |
23 ± 4B M |
21 ± 4 |
44 ± 7 |
111 ± 5 |
61 ± 10 |
|
10µg |
23 ± 4B M |
26 ± 1 |
41 ± 6 |
114 ± 4 |
61 ± 8 |
||
33µg |
24 ± 3B M |
22 ± 5 |
41 ± 4 |
110 ± 5 |
60 ± 5 |
||
100µg |
21 ± 3B M |
19 ± 2 |
46 ± 5 |
110 ± 15 |
50 ± 14 |
||
333µg |
23 ± 4B M |
20 ± 0 |
44 ± 1 |
112 ± 4 |
53 ± 2 |
||
1000µg |
17 ± 1P B M |
21 ± 8P |
45 ± 6P |
99 ± 1P |
52 ± 4P |
||
2500µg |
19 ± 1P B M |
21 ± 7P |
43 ± 13P |
101 ± 1P |
56 ± 2P |
||
5000µg |
19 ± 3P B M |
18 ± 3P |
30 ± 4P M |
94 ± 5P M |
45 ± 1P M |
||
2-AA |
2.5 µg |
224 ± 14 |
150 ± 14 |
1633 ± 69 |
1096 ± 96 |
|
|
2-AA |
10.0 µg |
|
|
|
|
359 ± 15 |
NaN3: sodium azide
2-AA: 2-aminoanthracene
4-NOPD: 4-nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
P: Precipitate
MB: Manual count
B: Extensive bacterial growth
Table: Summary of Results_Experiment II |
|||||||
|
|||||||
Metabolic Activation |
Test Group |
Dose Level (µg/plate) |
Revertant Colony Counts (Mean ±SD)
|
||||
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|||||||
Without metabolic Activation |
DMSO |
|
39 ± 2 |
13 ± 4 |
28 ± 6 |
130 ± 15 |
47 ± 16 |
Untreated |
|
39 ± 1 |
20 ± 2 |
25 ± 2 |
153 ± 12 |
47 ± 4 |
|
Hostacerin SFO |
33µg |
38 ± 5 |
10 ± 1 |
29 ± 8 |
123 ± 10 |
48 ± 4 |
|
100µg |
32 ± 2 |
12 ± 1 |
24 ± 4 |
122 ± 14 |
48 ± 9 |
||
333µg |
38 ± 2 |
11 ± 3 |
26 ± 8 |
129 ± 10 |
56 ± 5 |
||
1000µg |
31 ± 4P |
12 ± 6P |
23 ± 1P |
108 ± 10P R |
52 ± 6P |
||
2500µg |
25 ± 7P |
7 ± 1P R |
25 ± 7P |
91 ± 14P R |
43 ± 3P |
||
5000µg |
15 ± 2M R P |
7 ± 2P M R |
7 ± 1P M R |
76 ± 6P M R |
31 ± 7P M R |
||
NaN3 |
10 µg |
2642 ± 177 |
|
|
2794 ± 49 |
|
|
4-NOPD |
10 µg |
|
|
615 ± 42 |
|
|
|
4-NOPD |
50 µg |
|
140 ± 6 |
|
|
|
|
MMS |
3.0 µg |
|
|
|
|
355 ± 143 |
|
|
|||||||
With metabolic activation |
DMSO |
|
33 ± 6 |
18 ± 6 |
43 ± 5 |
134 ± 15 |
56 ± 8 |
Untreated |
|
33 ± 7 |
20 ± 5 |
43 ± 8 |
157 ± 10 |
47 ± 9 |
|
Hostacerin SFO |
33µg |
35 ± 11 |
17 ± 4 |
40 ± 8 |
139 ± 15 |
59 ± 5 |
|
100µg |
34 ± 11 |
18 ± 9 |
44 ± 8 |
136 ± 3 |
62 ± 6 |
||
333µg |
30 ± 7 |
20 ± 8 |
40 ± 8 |
133 ± 10 |
51 ± 10 |
||
1000µg |
35 ± 1P |
18 ± 4P |
43 ± 8P |
130 ± 21P |
64 ± 6P |
||
2500µg |
20 ± 4P R |
11 ± 2P M R |
38 ± 8P |
95 ± 2P R |
48 ± 6P M |
||
5000µg |
19 ± 3P M R |
5 ± 3P M R |
14 ± 3P M R |
40 ± 2P M R |
40 ± 8P M R |
||
2-AA |
2.5 µg |
276 ± 8 |
209 ± 5 |
1872 ± 143 |
2337 ± 376 |
|
|
2-AA |
10.0 µg |
|
|
|
|
243 ± 1 |
NaN3: sodium azide
2-AA: 2-aminoanthracene
4-NOPD: 4-nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
P: Precipitate
R: Reduced background count
MB: Manual count
Applicant's summary and conclusion
- Conclusions:
- The genotoxicity of the registration substance was investigated in bacterial reverse muation test (Ames test) according to the Guideline OECD 471. No mutagenicity was found.
- Executive summary:
The genotoxicity of the registration substance was investigated in bacterial reverse muation test (Ames test) according to the Guideline OECD 471. using TA 1535, TA 1537, TA 98, TA 100 and WP2 uvrA as test systems. At concentrations 1000 µg/plate and above precipitation occured. Up to the highest concentration of 5000 µg/plate no cytoxicity and no mutagenicity was found.
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.