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EC number: 421-820-9 | CAS number: 192268-65-8 CD 28-0132; IRGALUBE 232
- 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
The substance is considered to be not mutagenic based on the negative results in bacteria (OECD 471) (Huntington Life Sciences Ltd 1995) and in cultivated CHO cells (BASF 2011). It is not clastogenic based on the negative result in Chinese Hamster Lung Fibroblasts (OECD 473) (CCR 1997).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro Gene Mutation - Bacteria Cells
Using a test procedure that complies with the requirements of OECD TG 471, the test article was tested in a Bacterial Reverse Mutation Test using the plate incorporation method. Following strains were used: Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 as well as Escherichia coli (WP2 uvr A). In each of two runs, the test article was tested in triplicates at concentrations of 0, 312.5, 625, 1250, 2500 and 5000 µg/plate in the presence and absence of Aroclor-induced rat liver S-9 mix. The vehicle was dimethyl sulfoxide. Cytotoxicity was absent up to 5000 µg/plate.The concurrent positive control compounds demonstrated the sensitivity of the assay and the metabolising activity of the liver preparations. There was no evidence of induced mutant colonies over background up to the maximum dose of 5000 μg/ plate both in the presence and absence of metabolic activation (Huntingdon Life Sciences Ltd. 1995).
In vitro Gene Mutation - Mammalian Cells
The substance was assessed for its potential to induce gene mutations at the hypoxanthine-guanine phosphoribosyl transferase (HPRT) locus in Chinese hamster ovary (CHO) cells in vitro (BASF 2011). The study followed OECD testing guideline 476 and the principles of GLP. Two independent experiments were carried out, both with and without the addition of liver S9 mix from induced rats (exogenous metabolic activation). According to an initial range-finding cytotoxicity test for the determination of the experimental doses and taking into account the cytotoxicity actually found in the main experiments, the following doses were tested and the doses in bold type were evaluated in this study:
1st Experiment:
without S9 mix (4-hour exposure period): 0; 19.5; 39.1; 78.1; 156.3; 1 250.0; 2 500.0; 5 000.0 μg/mL
with S9 mix (4-hour exposure period): 0; 19.5; 39.1; 78.1; 156.3; 312.5; 625.0; 1 250.0 μg/mL
2nd Experiment:
without S9 mix (24-hour exposure period): 0; 25; 50; 100; 625; 1 250; 2 500; 5 000 μg/mL
with S9 mix (4-hour exposure period): 0; 25; 50; 100; 200; 400; 600; 800 μg/mL
After an attachment period of 20 - 24 hours and a treatment period of 4 hours both with and without metabolic activation and 24 hours without metabolic activation, an expression phase of about 6 - 8 days and a selection period of about 1 week followed. The colonies of each test group were fixed with methanol, stained with Giemsa and counted. The vehicle controls gave mutant frequencies within the range expected for the CHO cell line. Both positive control substances, EMS and MCA, led to the expected increase in the frequencies of forward mutations. Cytotoxicity indicated by reduced survival (CE1) of below 20% of control was observed in both experiments in the presence of metabolic activation only. On the basis from the results of the present study, the test substance did not cause any relevant increase in the mutant frequencies either without S9 mix or after adding a metabolizing system in two experiments performed independently of each other.
In Vitro Cytogenetics
In a mammalian in-vitro cytogenetic assay (chromosome aberration) that complies with the test requirements of OECD TG 473, Chinese hamster lung fibroblasts (V79) were exposed to the test article in dimethyl sulfoxide (1% final concentration) at concentrations of 10, 30, 50, 100, 300, and 1000 µg/mL for 4 hours (fixation interval of 18 hours) with metabolic activation and 18 hours without metabolic activation. Another set of cultures were exposed to concentrations of 50, 100, 300, and 1000 µg/mL for 4 hours (fixation interval of 28 hours) with metabolic activation and 28 hours without metabolic activation. Cytotoxic effects were evident from 100 µg/mL and above. However, toxicity was observed only in the presence of test article precipitation (> 100 µg/mL). Positive controls induced the appropriate response. Per culture, 100 metaphase were scored for structural chromosome aberrations. There was no evidence of chromosome aberration induced over background. Both in the absence and presence of S9-mix, the test article did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations or the number of polyploid cells (CCR, 1997).
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation 1272/2008. Based on the criteria laid down in Regulation (EC) No.1272/2008, classification for genetic toxicity is not warranted.
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.
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