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EC number: 700-641-2 | CAS number: 1261240-30-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 22 July 2010
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- dated 30 May 2008
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-tert-butyl-2-(5-tert-butyl-2-oxo-2,3-dihydro-1-benzofuran-3-yl)phenyl 3,5-di-tert-butyl-4-hydroxybenzoate
- EC Number:
- 700-641-2
- Cas Number:
- 1261240-30-5
- Molecular formula:
- C37H46O5
- IUPAC Name:
- 4-tert-butyl-2-(5-tert-butyl-2-oxo-2,3-dihydro-1-benzofuran-3-yl)phenyl 3,5-di-tert-butyl-4-hydroxybenzoate
- Test material form:
- other: Crystalline powder
- Details on test material:
- Batch No.: S25211001
Purity: 99.15%
Stability in solvent: Not indicated
Storage: at room temperature, light protected.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOIaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- (1) Details on test animals:
Number of animals for the pre-test: 2 females
Number of animals for the main study: 16 females
Number of animals per group 4 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1
Age: Pre-test: 11-12 weeks (beginning of treatment); main study: 9-10 weeks (beginning of treatment)
Identifcation: The animals were distributed into the test groups at random. All animals belonging to the same experimental group were kept in one cage. In the main experiment, the animals were identified by tail tags. In the pre-experiment, animals were identified by cage number.
Acclimatisation: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
(2) Details on environmental conditions
Housing: group
Cage type: Makrolon Type II (pre-test) / III (main study), with wire mesh top
Bedding: granulated soft wood bedding
Feed: pelleted standard diet, ad libitum
Water: tap water, ad libitum
Environment: Temperature: 22+/-2 degree C; Relative humidity: 30-65% (acclimation period), 45-65% (main study); Artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 10, 25, 50% (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear with test item concentrations of 10, 25, and 50% (w/v) in dimethylformamide. The application volume, 25 VL/ear/day, was spread over the entire dorsal surface ( Φ - 8 mm) of each ear once daily for three consecutive days. A further group of mice was treated with an equivalent volume of the relevant vehicle alone (control animals).
- Positive control substance(s):
- other: α-Hexylcinnamaldehyde
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables. However, both biological and statistical significance were considered together.
Results and discussion
- Positive control results:
- Test item concentration % (w/v) Group Measurement DPM DPM-BG No. of lymph nodes DPM per lymph node S.I. Result
- BGI 15 - - - -
- BGII 22 - - - -
0 1 3814 3796 8 474.4 1.00
5 2 6461 6443 8 805.3 1.70
10 3 6878 6860 8 857.4 1.81
25 4 22393 22375 8 2796.8 5.90
Vehicle: acetone: olive oil (4+1 v/v)
BG=Background (1 mL 5% trichloroacetic acid) in duplicate
1= Control Group
2-4= Test Group
S.I. = Stimulation Index
DPM-BG= The mean value was taken from the figures BGI and BGII
DPM per lymph node= since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled.
Calculation of the EC3 value (EC3=Estimated concentration for a S.I. of 3) = 14.4% (w/v)
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.04
- Variability:
- no data
- Test group / Remarks:
- Test item concentration: 10% (w/v)
Number of animal per group: 4 females (nulliparous and non-pregnant)
- Key result
- Parameter:
- SI
- Value:
- 1.07
- Variability:
- no data
- Test group / Remarks:
- Test item concentration 25% (w/v);
Number of animal per group: 4 females (nulliparous and non-pregnant)
- Key result
- Parameter:
- SI
- Value:
- 0.95
- Variability:
- no data
- Test group / Remarks:
- Test item concentration: 50% (w/v)
Number of animal per group: 4 females (nulliparous and non-pregnant)
Any other information on results incl. tables
Viability/Mortality: No deaths occurred during the study period.
Clinical Signs: No systemic findings were observed during the study period. On day 4 to 6, the animals treated with a test item concentration of 10 and 25% showed an erythema of the ear skin (Score 1). Animals treated with 50% test item concentration showed an erythema of the ear skin (Score 1) on day 4 and 6 and Score 2 on day 5.
Body Weights: The body weight of the animals, recorded prior to the first application and prior to treatment with 3HTdR, was within the range commonly recorded for animals of this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test substance was not a skin sensitiser under the test condition of this study.
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