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EC number: 946-420-6 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
consistently negative in the bacterial reverse mutation assay, mammalian cell gene mutation assay and mammalian cell chromosoem aberration assay
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-09 to 1996-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 26 th May, 1983
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine locus
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- The test concentrations were: 0, 8, 40, 200, 1000 and 5000 µg/plate based on the results from the dose range finding test.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility of the test substance and low amount of spontaneous revertants within the control. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- cumene hydroperoxide
- other: 2-Aminoanthracene (with S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable):1E09 cells/plate
DURATION
- Exposure duration: 65 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: background bacterial lawn - Evaluation criteria:
- A positive result is indicated by a dose response with statistically significant increases in revertant numbers
- Statistics:
- Mean standard deviations and Dunnett´s t-statistic
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxic at 5000 µg/plate without S9, not cytotoxic with S9 up to limit concentration
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- Under the conditions of this Ames test, polyglycerin caprinate was negative for mutagenic potential.
- Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471 (adopted 21 July 1997), Salmonella typhimurium strains TA 1535, TA 1537, TA 102, TA 98 and TA 100 were exposed to polyglycerin caprinate in DMSO in concentrations of 0 (control), 8, 40, 200, 1000 and 5000 µg/plate in all strains in the presence and absence of mammalian metabolic activation (rat liver S9 mix). The assay was performed using the plate incorporation method.
The test substance was tested up to limit concentrations. Cytotoxic effects (reduced background lawn) were noted at 5000 µg/plate without S9; no cytotoxicity was observed with S9 up to the limit concentration. The positive controls induced the appropriate responses in the corresponding strains.
There was no evidence of a statistically significant increase in the number of revertant colonies in any of the five tester strains. Therefore, test substance was considered to be non-genotoxic (non-mutagenic) in Salmonella tester strains TA 1535, TA 1537, TA 102, TA 98 and TA 100 under the conditions employed (plate incorporation assay).
There was no evidence of induced mutant colonies over background. Under the conditions of the study, the test substance was negative for mutagenic potential.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar physicochemical, ecotoxicological and toxicological properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: the target and source substances are esterification products of fatty acids of varying chain lengths with glycerol and/or polyglycerol.
• the metabolism pathway leads to comparable products (glycerol and/or polyglycerol and medium or long chain fatty acids).
Therefore, read-across from the existing toxicity studies on the source substances is considered as an appropriate adaptation to the standard information requirements of REACH regulation
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see “Justification for read-across” attached to IUCLID section 13
3. ANALOGUE APPROACH JUSTIFICATION
see “Justification for read-across” attached to IUCLID section 13
4. DATA MATRIX
see “Justification for read-across” attached to IUCLID section 13 - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain:
- other: CHO; human lymphocytes
- 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
- Conclusions:
- Interpretation of results: negative with and without metabolic activation
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar physicochemical, ecotoxicological and toxicological properties because
• they are manufactured from similar or identical precursors under similar conditions
• they share structural similarities with common functional groups: the target and source substances are esterification products of fatty acids of varying chain lengths with glycerol and/or polyglycerol.
• the metabolism pathway leads to comparable products (glycerol and/or polyglycerol and medium or long chain fatty acids).
Therefore, read-across from the existing toxicity studies on the source substances is considered as an appropriate adaptation to the standard information requirements of REACH regulation
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see “Justification for read-across” attached to IUCLID section 13
3. ANALOGUE APPROACH JUSTIFICATION
see “Justification for read-across” attached to IUCLID section 13
4. DATA MATRIX
see “Justification for read-across” attached to IUCLID section 13 - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- HPRT
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results: negative with and without metabolic activation
Referenceopen allclose all
Table 1:Number of revertants per plate (mean of 3 plates)
|
[strain 1535] |
[strain 1537] |
[strain 102] |
[strain 98] |
[strain 100] |
|||||
Conc. |
— MA |
+ MA |
— MA |
+ MA |
— MA |
+ MA |
— MA |
+ MA |
— MA |
+ MA |
0* |
8.3 |
11.7 |
8.0 |
6.0 |
228.7 |
209.0 |
19.3 |
44.0 |
81.3 |
90.0 |
8 |
15.3 |
11.7 |
9.3 |
7.5 |
229.7 |
259.0 |
22.0 |
40.0 |
91.0 |
91.3 |
40 |
12.7 |
8.7 |
10.0 |
8.0 |
215.7 |
253.7 |
21.0 |
34.7 |
100.7 |
84.0 |
200 |
18.7 |
9.7 |
7.0 |
11.5 |
192.7 |
214.3 |
27.3 |
31.3 |
93.7 |
91.7 |
1000 |
10.3 |
14.5 |
7.0 |
12.3 |
163.7 |
161.0 |
19.3 |
31.5 |
89.0 |
90.0 |
5000 |
b |
5.0 |
b |
3.0 |
a |
89.3 |
b |
20.3 |
a |
64.7 |
Positive control |
325.0 |
70.3 |
173.3 |
27.0 |
307.3 |
418.0 |
138.0 |
221.0 |
415.7 |
362.7 |
*solvent control with DMSO
b = Complete loss of lawn
a = Reduced lawn.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A bacterial reverse mutation assay was conducted with the target substance polyglycerin caprylate/caprinate. Additionally, genetic toxicity studies are available for the closely related source substances Medium- and long-chain triacylglycerols, short- and long-chain fatty acid triacylglycerols and1,2,3-Propanetriol, homopolymer, dodecanoate. A justification for read-across is given in iuclid section 13.
Bacterial reverse mutation assays
In a reverse gene mutation assay in bacteria according to OECD guideline 471 (adopted 21 July 1997), Salmonella typhimurium strains TA 1535, TA 1537, TA 102, TA 98 and TA 100 were exposed to polyglycerin caprinate in DMSO in concentrations of 0 (control), 8, 40, 200, 1000 and 5000 µg/plate in all strains in the presence and absence of mammalian metabolic activation (rat liver S9 mix). The assay was performed using the plate incorporation method.
The test substance was tested up to limit concentrations. Cytotoxic effects (reduced background lawn) were noted at 5000 µg/plate without S9; no cytotoxicity was observed with S9 up to the limit concentration. The positive controls induced the appropriate responses in the corresponding strains.
There was no evidence of a statistically significant increase in the number of revertant colonies in any of the five tester strains. Therefore, test substance was considered to be non-genotoxic (non-mutagenic) in Salmonella tester strains TA 1535, TA 1537, TA 102, TA 98 and TA 100 under the conditions employed (plate incorporation assay).
There was no evidence of induced mutant colonies over background. Under the conditions of the study, the test substance was negative for mutagenic potential.
Medium- and long-chain triacylglycerols (MLCT) did not induce gene mutations in 4 different Salmonella (S. typhimurium TA 1535, TA 1537, TA 98 and TA 100) and one E. coli strain (E. coli WP2 uvr A) when tested up to limit concentrations (0, 313, 625, 1250, 2500, 5000 µg/plate).
in vitro gene mutation study in mammalian cells
An HPRT test was conducted withshort- and long-chain fatty acid triacylglycerols (SALATRIM) in Chinese hamster Ovary (CHO) cells at concentrations of 0, 31.25, 62.5, 125, 250, 500 and 1000 μg/mL. The high dose was limited by the low solubility of the fats in the assay medium. There was no evidence of mutagenic potential under the conditions of the assay.
Chromosome aberration assays
An in vitro mammalian chromosome aberration test was conducted withshort- and long-chain fatty acid triacylglycerols (SALATRIM) Chinese hamster Ovary (CHO) cells at concentrations of 250, 500 and 1000 µg/mL ion acetone.
There was no change in the mitotic index with either fat compared to the solvent control. Neither fat produced increases in the percent cells with abnormal chromosomes or in any of the other criteria for chromosomal damage. Therefore, short- and long-chain fatty acid triacylglycerols were neither clastogenic nor cytotoxic in the chromosomal aberration assay in the presence or absence of metabolic activation.
An in vitro mammalian chromosome aberration test was conducted with 1,2,3-Propanetriol, homopolymer, dodecanoate in Chinese hamster lung fibroblasts (V79) up to cytotoxic concentrations.
Without metabolic activation a slight increase of aberrant cells was observed at concentrations of 50 and 70 µg/mL but not at 65 µg/mL. With metabolic activation, the aberration rates of the higher concentrations (1250 and 1500 µg/mL) were significantly increased and a dose relationship was observed.
The test substance was clastogenic to chinese hamster V79 cells treated in vitro under the conditions of the test.
However, cytotoxicity was observed at concentrations ≥ 65 µg/mL without metabolic activation and at concentrations ≥ 1250 µg/mL with metabolic activation. Thus, chromosome aberrations were only observed in the presence of cytotoxic effects.
A second in vitro mammalian chromosome aberration test was conducted with 1,2,3-Propanetriol, homopolymer, dodecanoate in human lymphocytes up to cytotoxic concentrations
No significant increases in chromosomal aberrant aberrations were observed in any treatment group at any dose level. The test substance was not clastogenic to human lymphocytes treated in vitro under the conditions of the test.
Considering that the second study was negative and the first positive only in the presence of marked cytotoxicity, the first chromosome aberration test can be considered a false positive.
Conclusion
Overall, the target substancePolyglycerin caprylate/caprinate is neither mutagenic nor clastogenic in vitro based on the Ames test conducted with the target substance and the mammalian cell gene mutation assay as well as the chromosome aberration tests conducted with closely related source substances.
There are no data gaps for the endpoint genetic toxicity. There is no reason to believe that the results would not be relevant to humans.
Justification for classification or non-classification
Based on the available data, polyglycerin caprylate/caprinate does not need to be classified for mutagenicity according to regulation (EC) 1272/2008. Thus, no labelling is required.
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