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EC number: 404-800-4 | CAS number: 118832-72-7 IRGANOX L 118
- 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:
- 1988-02-02 to 1988-08-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study, GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Iso(C10-C14)alkyl (3,5-di-tert-butyl-4-hydroxyphenyl)methylthioacetate
- EC Number:
- 404-800-4
- EC Name:
- Iso(C10-C14)alkyl (3,5-di-tert-butyl-4-hydroxyphenyl)methylthioacetate
- Cas Number:
- 118832-72-7
- Molecular formula:
- C30H52O3S
- IUPAC Name:
- 11-methyldodecyl 2-{[(3,5-di-tert-butyl-4-hydroxyphenyl)methyl]sulfanyl}acetate
- Details on test material:
- - Physical state: liquid
- Analytical purity: commercial grade
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- This test system permits the detection of point mutations induced by the test material or its metabolites in histidine-requiring strains of Salmonella typhimurium and in tryptophan-requiring strain of Escherichia coli.
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98, TA 100 and E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Range in the cytotoxicity test: 0.08 - 5000 µg/ 0.1 mL
Range in the mutagenicity test without and with microsomal activation: 5 - 5000 µg/ 0.1 mL. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethylformamide
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethylformamide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: TA 98 and TA 1538: 2-nitrofluorene; TA 100, E.coli WP2 uvrA: N-ethyl-N'-nitro-N-nitrosoguanidine; TA 1535: sodium azide; TA 1537: 9(5)-aminoacridine hydrochloride monohydrate
- Remarks:
- without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethylformamide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: TA 98, TA 100, TA 1537 and TA 1538: benzo(a)pyrene; TA 1535, E.coli WP2uvrA: 2-aminoanthracene
- Remarks:
- with S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
NUMBER OF REPLICATIONS: 3 per experiment, two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: colony count
TEST PERFORMANCE
A preliminary toxicity test on strain TA100 was carried out with the concentrations ranging from 0.08 to 5000 µg/0.1 mL. The protocol used was the same as in the mutagenicity test. Accordingly, the concentration of 5000 µg/0.1 mL was used as the highest in the mutagenicity test and the tests were performed with the following concentrations of the test substance without and with microsomal activation: 5, 10, 50, 100, 500, 1000 and 5000 µg/0.1 mL. The substance was dissolved in the negative control item dimethylformamide. Each Petri dish contained: 1) approx. 20 mL of minimum agar (agar, (bacteriological grade) plus salts and glucose), 2) 0.1 mL of a solution of the test substance or the vehicle and 0.1 mL of a bacterial culture in 2.0 mL of soft agar. For the Salmonella strains the soft agar was composed of: 100 mL of 0.6% agar solution with 0.6% NaCL and 10 mL of an aqueous solution of 1-histidine, 0.5 mM and +biotin 0.5 mM. For the E. coli strain the 1-histidine and the +biotin were replaced by 1- tryptophan, 0.5 mM in bidistilled water. In the experiments without microsomal activation 0.5 mL of M/10 sodium phosphate buffer was added. In the experiments in which the substance was metabolically activated, the buffer was replaced by 0.5 mL of an activation mixture. 1 mL activation mixture contained: 0.1 mL S9 fraction of liver from rats (Tif:RAIf(SPF)) induced with Aroclor 1254 and 0.9 mL of a solution of co-factors. - Evaluation criteria:
- Criteria for a positive response:
The test substance is considered to be mutagenic in this test system if one or both of the following conditions are met:
- At least a reproducible doubling of the mean number of revertants per plate above that of the negative control at any concentration for one or more of the following strains: S. typhimurium TA 98, TA 1535, TA 1537, TA 1538 and E.coli WPuvrA.
- A reproducible increase of the mean number of revertants per plate for any concentration above that of the negative control by at least a factor of 1.5 for strain S. typhimurium TA 100.
Generally a concentration-related effect should be demonstrable. - Statistics:
- A statistical analysis was not performed.
Results and discussion
Test results
- Species / strain:
- other: S.typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538 and Escherichia coli WP2 uvrA
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: At the concentrations of 312.5 µg/0.1 ml and above the substance precipitated in soft agar.
RANGE-FINDING/SCREENING STUDIES:
Nine concentrations of the test substance ranging from 0.08 to 5000 µg/0.1 ml were tested to determine the highest concentration to be used in the mutagenicity assay. No cytotoxicity was observed. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Experiment I
TA 98 | TA 100 | TA 1535 | TA 1537 | TA 1538 | WP2 uvrA | |||||||
Dose (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
solvent control | 16 | 26 | 94 | 96 | 13 | 8 | 6 | 13 | 10 | 15 | 23 | 24 |
5 | 18 | 24 | 103 | 113 | 12 | 11 | 6 | 13 | 8 | 21 | 24 | 20 |
10 | 12 | 29 | 99 | 97 | 16 | 10 | 5 | 16 | 8 | 18 | 18 | 20 |
50 | 9 | 27 | 92 | 104 | 13 | 11 | 11 | 13 | 8 | 21 | 22 | 27 |
100 | 19 | 30 | 102 | 94 | 14 | 11 | 5 | 12 | 6 | 15 | 16 | 20 |
500 | 16 | 23 | 100 | 107 | 20 | 9 | 6 | 10 | 9 | 19 | 21 | 22 |
1000 | 18 | 28 | 108 | 109 | 14 | 9 | 7 | 17 | 6 | 15 | 16 | 24 |
5000 | 20 | 26 | 105 | 96 | 7 | 13 | 9 | 10 | 7 | 13 | 18 | 21 |
solvent control | 16 | 25 | 106 | 112 | 14 | 10 | 9 | 18 | 9 | 17 | 25 | 21 |
positive control A | 156 | 236 | 384 | 978 | 311 | 97 | 27 | 159 | 224 | 155 | 546 | 465 |
positive control B | 245 | 271 | 783 | 912 | 495 | 85 | 377 | 133 | 399 | 107 | 1263 | 581 |
Experiment II
TA 98 | TA 100 | TA 1535 | TA 1537 | TA 1538 | WP2 uvrA | |||||||
Dose (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
solvent control | 15 | 29 | 109 | 106 | 19 | 9 | 5 | 8 | 8 | 16 | 27 | 24 |
5 | 19 | 34 | 110 | 92 | 14 | 6 | 6 | 6 | 6 | 12 | 27 | 20 |
10 | 16 | 31 | 108 | 86 | 17 | 11 | 3 | 7 | 13 | 15 | 26 | 21 |
50 | 21 | 28 | 114 | 84 | 13 | 4 | 8 | 12 | 6 | 17 | 28 | 16 |
100 | 17 | 30 | 115 | 97 | 14 | 7 | 6 | 9 | 6 | 15 | 31 | 17 |
500 | 22 | 29 | 109 | 89 | 17 | 11 | 5 | 5 | 11 | 16 | 32 | 25 |
1000 | 18 | 36 | 104 | 88 | 12 | 8 | 6 | 6 | 7 | 17 | 32 | 16 |
5000 | 20 | 32 | 108 | 80 | 15 | 9 | 5 | 7 | 9 | 18 | 25 | 20 |
solvent control | 17 | 22 | 121 | 93 | 17 | 8 | 8 | 14 | 10 | 19 | 24 | 21 |
positive control A | 142 | 340 | 561 | 1083 | 290 | 72 | 16 | 208 | 242 | 173 | 524 | 372 |
positive control B | 250 | 276 | 843 | 1395 | 415 | 58 | 183 | 114 | 361 | 198 | 1189 | 456 |
Positive controls:
Without S9 mix:
TA 98, TA 1538: 2-nitrofluorene, 1.0 (A) and 2.0 (B) µg/0.1 mL dimethylsulfoxide
TA 100: 4N-ethyl-N'-nitro-N-nitrosoguanidine, 3.0 (A) and 5.0 (B) µg/0.1 ml dimethylsulfoxide
TA 1535: sodium azide, 0.5 (A) and 1.0 (B) µg/0.1 ml bidistilled water
TA 1537: 9(5)- aminoacridine hydrochloride monohydrate, 40 (A) and 80 (B) µg/0.1 mL dimethylsulfoxide
WP2 uvrA: N-ethyl-N'-nitro-N-nitrosoguanidine, 2.0 (A) and 5.0 (B) µg/0.1 ml dimethylsulfoxide
With S9-Mix:
TA 98, TA 100, TA 1537, TA 1538: benzo(a)pyrene, 5.0 (A) and 10 (B) µg/0.1 ml dimethylsulfoxide
TA 1535: 2-aminoanthracene, 2.0 (A) and 4.0 (B) µg/0.1 mL dimethylsolfoxide
WP2 uvrA: 2-aminoanthracene, 40 (A) and 80 (B) µg/0.1 ml dimethylsulfoxide
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative - Executive summary:
A GLP-compliant Salmonella typhimurium and E. coli reverse mutation assay was carried out according to OECD Guideline 471. Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 as well as E. coli strain WP2uvrA were tested for the induction of base-pair substitutions or frameshift mutations. The experiment was conducted in the presence and absence of a rat liver S-9-microsomal activation system and at concentrations of 5-5000 μg per plate. The experiment was repeated independently for confirmation. At concentrations of 312.5 µg/0.1 ml and above the substance precipitated in soft agar. No evidence of a mutagenic potential was observed. In the experiments performed without and with microsomal activation, comparison of the number of back-mutant colonies in the controls and the cultures treated with the various concentrations of the test substance revealed no marked deviations. Cytotoxicity did not occur up to and including the highest dose tested. Based on this result, no evidence of the induction of point mutations was detectable in the strains of S. typhimurium and Escherichia coli used in these experiments.
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