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EC number: 700-814-2 | 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:
- 2000-06-15 to 2000-06-29
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- ZINN(II)-RICINOLEAT
- IUPAC Name:
- ZINN(II)-RICINOLEAT
- Reference substance name:
- Reaction products of ricinoleic acid and linoleic acid and oleic acid with sodium hydroxide and tin (II) chloride
- EC Number:
- 700-814-2
- Molecular formula:
- not applicable UVCB substance
- IUPAC Name:
- Reaction products of ricinoleic acid and linoleic acid and oleic acid with sodium hydroxide and tin (II) chloride
- Test material form:
- liquid: viscous
Constituent 1
Constituent 2
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:
- S9 preparation from Aroclor 1254 induced rats
- Test concentrations with justification for top dose:
- 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate
- Vehicle / solvent:
- dimethyl sulfoxide
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: without S9: sodium azide, 9-aminoacridine, daunomycine, methylmethanesulfonate, 4-nitroquinoline N-oxide; with S9: 2-aminoanthracene.
- Details on test system and experimental conditions:
- Test System : Salmonella typhimurium bacteria and Escherichia coli bacteria
Rationale : Recommended test system in international guidelines (e.g. EPA, OECD, EEC).
Source : Dr. Bruce N. Ames, University of California at Berkeley, U.S.A. (Salmonella typhimurium strains); TA100 received 18-02-1993, used batches: T100.291 099 and TA100.040500; TA98 received 21-02-1991, used batch: T A98.170200; T A 1535 received 14-12-1994, used batch: T A 1535.170200; T A 1537 received 14-12-1994, used batch: T A 1537 .170200; Prof. Dr. B.A. Bridges, University of Sussex, Brighton, U.K., (Escherichia coli strain) WP2uvrA received 23-10-1987, used batch: EC.040500.
Preparation of
Bacterial cultures : Samples of frozen stock cultures of bacteria were transferred into enriched nutrient broth (Oxoid no. 2) and incubated in a shaking incubator (37 °C, 150 spm), until the cultures reached an optical density of 1.0 at 700 nm (10 9 cells/ml). Freshly grown cultures of each strain were used for a test.
Permeabilization of the
Escherichia coli strain : WP2uvrA bacteria were washed twice in 0.25 the original volume of ice-cold 0.12 M Tris-HCl buffer pH 8.0, then gently resuspended in 0.2 vol. 0.12 M Tris HCl, 0.5 mM EDTA pH 8.0, and shaken for 2.5 min at 37 °C. MgCI 2 was then added to a final concentration of
10 mM. The cells were centrifuged and resuspended in the original volume of nutrient broth.
Agar plates : Agar plates (0 9 cm) contained 25 ml glucose agar medium. Glucose agar medium contained per liter: 18 g purified agar (Oxoid, code l28) in Vogel-Bonner Medium E, 20 g glucose. N.B. The agar plates for the test with the Salmonella typhimurium strains also contained 12.5 µg/plate biotin and 15 µg/plate histidine and the agar plates for the test with the Escherichia coli strain contained 15 µg/plate tryptophan.
Top agar : Vogel-Bonner Medium E containing 0.6% (w/v) purified agar was heated to dissolve the agar. Samples of 3 ml top agar were transferred into 10 ml glass tubes with metal caps. Top agar tubes were autoclaved for 20 min at 121°C.
Environmental conditions : All incubations were carried out in the dark at 37 °C. The temperature was monitored during the experiment. - Evaluation criteria:
- No formal hypothesis testing was done.
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) It induces a number of revertant colonies, dose related, greater than two-times the number of revertants induced by the solvent control in any of the tester strains, either with or without metabolic activation. However, any mean plate count of less than 20 is considered to be not significant.
b) The positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Experiment 1:
Precipitate: ZINN(II)-RICINOLEAT precipitated in the top agar at concentrations of 1000 and 3330 µg/plate. Precipitation of ZINN(II)-RICINOLEAT on the plates was observed at the start and at the end of the incubation period at the concentration of 3330 µg/plate.
Toxicity: In tester strain TA 1537 in the absence of S9-mix, a moderate reduction in the number of revertant colonies was observed at the test substance concentration of 1000 µg/plate. An extreme reduction in the number of revertant colonies and a slight reduction of the bacterial
background lawn were observed at the concentration of 3330 µg/plate. In the presence of S9-mix, no revertant colonies were observed at the test substance concentration of 3330 µg/plate. In tester strain TA 1535 and T A98, the bacterial background lawn was not reduced at all concentrations tested and no decrease in the number of revertants was observed.
Mutagenicity: No increase in the number of revertants was observed upon treatment with ZINN(II)-RICINOLEAT.
Experiment 2:
Precipitate: ZINN(II)-RICINOLEAT precipitated in the top agar at concentrations of 1000 µg/plate and upwards. Precipitation of ZINN(II)-RICINOLEAT on the plates was observed at the start and at the end of the incubation period at concentrations of 1670 and 3330 µg/plate.
Toxicity: In tester strain TA 100 in the absence and presence of S9-mix, a moderate reduction in the number of revertant colonies and a slight reduction of the bacterial background lawn were observed at the test substance concentration of 3330 µg/plate. In the other tester strains TA 1535, TA 1537, TA98 and WP2uvrA, the bacterial background lawn was not reduced at all concentrations tested and no decrease in the number of revertants was observed.
Mutagenicity: No increase in the number of revertants was observed upon treatment with ZINN(II)-RICINOLEAT. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Experiment 1: MUTAGENIC RESPONSE OF ZINN(II)-RICINOLEAT IN THE SALMONELLA TYPHIMURIUM REVERSE MUTATION ASSAY AND IN THE ESCHERICHIA COLI REVERSE MUTATION ASSAY
Dose [µg/plate] |
Mean number of revertant colonies/3 replicates (±S.D.) with different strains of Salmonella typhimurium and one Escherichia coli strain |
||||
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2uvrA |
|
Without S9 |
||||
Positive control |
723±68 |
334±39 |
442±34 |
419±90 |
406±35 |
Solvent control |
15±4 |
8±2 |
27±1 |
66±10 |
17±3 |
3 |
- |
- |
- |
57±3 |
19±2 |
10 |
- |
- |
- |
60±2 |
18±1 |
33 |
12±3 |
10±2 |
29±3 |
60±4 |
18±2 |
100 |
11±5 |
7±2 |
21±3 |
57±5 |
18±3 |
333 |
8±3 |
8±4 |
29±2 |
54±7 |
19±1 |
1000 |
13±1 |
4±3 |
27±3 |
40±0 |
17±2 |
3330 SP |
11±3 |
1±1 ** |
24±4 |
24±5 ** |
17±3 |
5000 SP |
- |
- |
- |
18±2 ** |
16±1 |
|
With S9 * |
||||
Positive control |
272±43 |
724±46 |
585±15 |
427±89 |
171±14 |
Solvent control |
13±5 |
7±2 |
27±4 |
67±8 |
18±3 |
3 |
- |
- |
- |
56±1 |
20±0 |
10 |
- |
- |
- |
62±8 |
21±3 |
33 |
13±5 |
7±2 |
24±2 |
62±6 |
20±4 |
100 |
10±3 |
6±2 |
27±5 |
64±7 |
21±1 |
333 |
8±3 |
5±1 |
30±3 |
60±5 |
20±4 |
1000 |
13±3 |
7±4 |
28±3 |
49±5 |
17±2 |
3330 |
10±1 |
0±0 |
25±6 |
16±4 ** |
15±4 |
5000 |
- |
- |
- |
19±6** |
17±3 |
Solvent control: 0.1 ml dimethyl sulfoxide
*The S9-mix contained 5% (v/v) S9 fraction
**Bacterial background lawn slightly reduced
SP Slight Precipitate
- Not tested
Experiment 2: MUTAGENIC RESPONSE OF ZINN(II)-RICINOLEAT IN THE SALMONELLA TYPHIMURIUM REVERSE MUTATION ASSAY AND IN THE ESCHERICHIA COLI REVERSE MUTATION ASSAY
Dose [µg/plate] |
Mean number of revertant colonies/3 replicates (±S.D.) with different strains of Salmonella typhimurium and one Escherichia coli strain |
||||
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2uvrA |
|
Without S9 |
||||
Positive control |
410±6 |
246±62 |
494±41 |
709±116 |
171±41 |
Solvent control |
12±2 |
4±1 |
15±2 |
67±11 |
15±3 |
33 |
8±4 |
5±2 |
16±3 |
92±18 |
8±4 |
100 |
12±2 |
3±1 |
18±3 |
83±3 |
7±2 |
333 |
13±5 |
3±1 |
19±2 |
83±6 |
7±1 |
1000 |
8±1 |
3±0 |
13±2 |
54±7 |
8±3 |
1670 SP |
- |
3±0 |
- |
- |
- |
3330 SP |
8±2 |
- |
14±1 |
27±3 ** |
8±2 |
|
With S9 * |
||||
Positive control |
258±19 |
245±14 |
541±19 |
728±66 |
349±20 |
Solvent control |
13±3 |
3±1 |
22±4 |
66±6 |
14±3 |
33 |
12±3 |
5±1 |
20±2 |
76±7 |
8±3 |
100 |
15±3 |
5±1 |
24±3 |
74±1 |
7±2 |
333 |
14±2 |
5±3 |
19±3 |
64±9 |
7±3 |
1000 |
12±2 |
4±0 |
17±3 |
58±7 |
7±1 |
1670 |
- |
5±1 |
- |
- |
- |
3330 |
13±3 |
- |
13±1 |
39±4 ** |
10±3 |
Solvent control: 0.1 ml dimethyl sulfoxide
*The S9-mix contained 10 % (v/v) S9 fraction
**Bacterial background lawn slightly reduced
SP Slight Precipitate
- Not tested
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the results of this study it is concluded that ZINN(II)-RICINOLEAT is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. - Executive summary:
ZINN(II)-RICINOLEAT was tested in the Salmonella typhimurium reverse mutation assay with four histidine-requiring strains of Salmonella typhimurium (TA 1535, TA 1537, TA 100 and TA98) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coliWP2uvrA in two independent experiments.
In the dose range finding test, ZINN(II)-RICINOLEAT was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix in the strains TA 100 and WP2uvrA. ZINN(II)RICINOLEAT precipitated on the plates at dose levels of 3330 µg/plate and upwards. In tester strain WP2uvrA, the bacterial background lawn was not reduced at all concentrations tested and no decrease in the number of revertants was observed. In tester strain TA 100, toxicity was observed at dose levels of 1000 µg/plate and upwards in the absence and presence of S9-mix.
In the first mutation experiment, ZINN(II)-RICINOLEAT was tested up to concentrations of 3330 µg/plate in the absence and presence of S9-mix in the strains TA1535, TA1537 and TA98. In the second mutation experiment, ZINN(II)-RICINOLEAT was tested up to concentrations of 3330 µg/plate in the absence and presence of S9-mix in the strains TA 1535, TA98, TA 100 and
WP2uvrA. ZINN(II)-RICINOLEAT was tested up to concentrations of 1670 µg/plate in the absence and presence of S9-mix in the strain TA1537.
ZINN(II)-RICINOLEAT did not induce a dose-related, two-fold, increase in the number of revertant (His+) colonies in each of the four tester strains (TA 1535, TA 1537, TA98 and TA 100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment.
Based on the results of this study it is concluded that ZINN(II)-RICINOLEAT is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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