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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 vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-07-04 to 1989-02-07
- 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:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5395 (In Vivo Mammalian Cytogenics Tests: Erythrocyte Micronucleus Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: EEC (19 September 1984), Mutagenicity (Micronucleus Test). Official Journal of the European Communities No L 251 137-139.
- GLP compliance:
- yes
- Type of assay:
- micronucleus 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
Constituent 1
Test animals
- Species:
- hamster
- Strain:
- other: Cricetulus griseus
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Tierfarm, Sisseln
- Weight at study initiation: females 31-34 g, males 30-35 g (tolerability test), females 21-31 g, males 22-34 g (mutagenicity test).
- Assigned to test groups randomly: yes
- Housing: Individually
- Diet: ad libitum (NAFAG No. 924)
- Water: tap water, ad libitum
- Acclimation period: At least 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 - 23
- Humidity (%): 50 - 84
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: arachis oil
- Details on exposure:
- The preparation was administered orally to groups of 24 female and 24 male animals each in the negative and in the 5000 mg/kg bw dose group. The positive control group consisted of 8 female and 8 male animals. Treatment consisted of a single application. 16, 24 and 48 hours after application 8 female and 8 male animals per sampling time were sacrificed by dislocation of the cervical vertebrae.
- Duration of treatment / exposure:
- Single exposure
- Frequency of treatment:
- Once
- Post exposure period:
- 16, 24, 48 hrs
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- In the tolerability test: 2 females and 2 males
In the mutagenicity test: 24 females and 24 males in the treatment groups and in the negative control groups. 8 females and 8 males in the positive control group - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- yes (CPA; Cyclophosphamide)
Examinations
- Tissues and cell types examined:
- Bone marrow was harvested from the shafts of both femurs with fetal calf serum. After centrifugation small drops of the sediment mixture were transferred on the end of a slide, spread out with the aid of a polished cover glass and air-dried. Within 24 hours, the slides were stained in undiluted May-Grünwald solution for 3 min then in May-Grünwald solution/water 1/1 for 2 min. After being rinsed in distilled water, the slides were left immersed in diluted Giemsa solution (16.6%), for 10 min. After rinsing with distilled water and air-drying, the slides were cleared in Xylene and mounted.
- Details of tissue and slide preparation:
- The slides of five animals from each sex showing the best differentiation between mature and polychromatic erythrocytes were selected for later scoring. The slides of five female and five male animals each of the negative control group and of the dosage group sacrificed at 16, 24 and 48 hours post treatment were examined. From the animals of the positive control group which were sacrificed 24 hours after application, the slides of five female and five male animals were scored. 1000 polychromatic erythrocytes per animal each were scored for the incidence of micronuclei. To determine the mitotic activity of the red compartment, the ratio of polychromatic to normochromatic erythrocytes was calculated for each animal by counting a total of 1000 erythrocytes. A low proportion of polychromatic erythrocytes is indicative for a mitosis inhibiting activity of the test substance.
- Evaluation criteria:
- - The quality of the slides must allow a clear differentiation between polychromatic and normochromatic erythrocytes.
- The result obtained with the positive control has to fulfill the criteria given for a positive response. - Statistics:
- The significance of difference was assessed by X2-test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
Three groups of four Chinese hamsters (two females and two males) are treated with three different doses, one receiving the maximum dose of 5000 mg/kg, or the highest applicable dose, and the other two doses of 1/5 and 1/25 of that amount respectively. The animals are treated with a single dose. The observation period corresponds to the interval between administration and sacrifice of the animals in the mutagenicity test, plus one day. In this experiment the dose of 5000 mg/kg was determined as the highest applicable in the mutagenicity assay
POSITIVE CONTROL
The positive control (cyclophosphamide, 64 mg/kg, sampling time 24 hours) yielded a marked increase of the percentage of micronucleated cells. Here the mean percentage of polychromatic erythrocytes with micronuclei was 1.00. In comparison with the negative control (0.08) this value is highly significant (p <0.05), confirming an appropriate sensitivity of the test system.
Any other information on results incl. tables
Experimental Result
Sacrifice | Treatment | Sex | polychromatic erythrocytes (average) |
normochromatic erythrocytes (average) |
ratio of p / n erythrocytes |
number of polychromatic erythrocytes with micronuclei (average) |
% of polychromatic erythrocytes with micronuclei (average) |
16 h | Control | female | 510 | 490 | 1 | 0.6 | 0.06 |
male | 603 | 397 | 1.5 | 0 | 0 | ||
5000 mg/kg | female | 548 | 452 | 1.2 | 0.6 | 0.06 | |
male | 632 | 368 | 1.7 | 0.8 | 0.08 | ||
24 h | Control | female | 512 | 488 | 1 | 1 | 0.1 |
male | 573 | 427 | 1.3 | 0.6 | 0.06 | ||
5000 mg/kg | female | 544 | 456 | 1.2 | 0.4 | 0.04 | |
male | 657 | 343 | 1.9 | 0.4 | 0.04 | ||
48 h | Control | female | 581 | 419 | 1.4 | 0.6 | 0.06 |
male | 648 | 352 | 1.8 | 0.2 | 0.02 | ||
5000 mg/kg | female | 485 | 515 | 0.9 | 0.8 | 0.08 | |
male | 605 | 395 | 1.5 | 0.4 | 0.04 | ||
Positive Control |
|||||||
48 h | Control | female | 512 | 488 | 1 | 1 | 0.1 |
male | 573 | 427 | 1.3 | 0.6 | 0.06 | ||
64 mg/kg | female | 523 | 477 | 1.1 | 12.6 | 1.26 | |
male | 581 | 419 | 1.4 | 7.4 | 0.74 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
- Executive summary:
The test item was assessed in the micronucleus assay for its potential to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow cells of the Chinese hamster. The test item was administered orally to groups of 24 female and 24 male animals at 0 (vehicle control) or 5000 mg/kg bw. 16, 24 and 48 hours after application 8 females and 8 males per sampling time were sacrificed and bone-marrow smears were prepared. There was no significant increase in the number of micronucleated polychromatic erythrocytes in the animals treated with the dose of 5000 mg/kg bw of the test item as compared with the negative control animals at all three sampling times. The positive control group (cyclophosphamide) consisted of 8 female and 8 male animals and showed the appropriate response, thus confirming sensitivity of the test system. In conclusion, it can be stated that during the study described and under the experimental conditions reported, the test item did not induce micronuclei as determined by the micronucleus test in the bone marrow cells of the Chinese hamster.
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