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EC number: 241-533-0 | CAS number: 17540-75-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 Oct 1999 - 10 Jan 2000
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4-sec-butyl-2,6-di-tert-butylphenol
- EC Number:
- 241-533-0
- EC Name:
- 4-sec-butyl-2,6-di-tert-butylphenol
- Cas Number:
- 17540-75-9
- Molecular formula:
- C18H30O
- IUPAC Name:
- 4-(butan-2-yl)-2,6-di-tert-butylphenol
- Test material form:
- liquid
- Details on test material:
- Appearance: Colorless to yellow liquid.
Storage: At room temperature under a nitrogen blanket.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Harlan Sprague Dawley, Inc.
- Age at study initiation: Young adult animals
- Weight at study initiation: males 245-268 g; females 175-203 g
- Fasting period before study: Yes
- Housing: Housed individually in suspended stainless steel cages
- Diet: Available ad libtum (PMI Certified Rodent Chow #5002 (Purina Mills, Inc.))
- Water: Free acces to municipal tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 – 23
- Humidity (%): 34 - 74
- Air changes (per hr): approx 10-15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 10 November 1999 to 10 Januari 2000
Administration / exposure
- Route of administration:
- oral: gavage
- Details on oral exposure:
- GAVAGE METHOD: A ball tipped stainless steel gavage needle attached to a syringe
Frequency: single dosage, on day 0.
MAXIMUM DOSE VOLUME APPLIED:
6.67 mL/kg body weight.
Density of substance (0.90 g/mL)
DOSAGE PREPARATION:
Test substance was administered as received from the sponsor and dispensed fresh on the day of dosing. - Doses:
- 6000 mg/kg body weight
5000 mg/kg body weight
2000 mg/kg body weight - No. of animals per sex per dose:
- 6000 mg/kg body weight - 5 females
5000 mg/kg body weight - 5 males and 5 females
2000 mg/kg body weight - 5 females - Control animals:
- no
- Details on study design:
- Individual doses were calculated based on the animal's fasted (day 0) body weight.
- Duration of observation period following administration: 14 days
- Frequency of observations: twice on day 0 (post dose) and thereafter daily
Mortality/Viability: twice daily
Body weights: Individual body weights were obtained for the LD50 study animals prior to fasting (day -1), prior to dosing on day 0 and for all surviving animals on days 7 and 14. Animals found dead after day 0 were also weighed.
Clinical signs: At periodic intervals on the day of dosing (Day 0) and once daily thereafter, until Day 14.
- Necropsy of survivors performed: All LD50 study animals which died spontaneously during the study or were euthanized by carbon dioxide inhalation at study termination (day 14) were necropsied. - Statistics:
- The LD50 and 95% confidence intervals were calculated for females using a computer adaption of the method Litchfield and Wilcoxon.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 6 662 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 3 920.1 - <= 11 320.4
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 6000 mg/kg body weight - 2/5 females
5000 mg/kg body weight - 0/5 males and 2/5 females
2000 mg/kg body weight - 0/5 females
All mortality occured by study day 5 - Clinical signs:
- other: The most notable clinical abnormalities observed during the study included decreased activity, wobbly gait, breathing abnormalities, soft/mucoid stools, decreased defecation,decreased food consumption, fecal/urine stain, rough haircoat, hunched posture, o
- Gross pathology:
- Gross internal findings observed in the animals that died included two incidences of abnormal content in the small intestine. No significant gross internal findings were observed at necropsy on study day 14.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- An acute oral toxicity study with ISONOX-132 in rats was performed similar to OECD 401. The acute oral LD50 of ISONOX-132 in the male rat was estimated to be > 5000 mg/kg body weight . In the female rat, the oral LD50 was determined to be 6662 mg/kg body weight. Therefore the substance does not need to classified according to GHS and CLP criteria.
- Executive summary:
An acute oral toxicity study with ISONOX-132 in rats was performed according to OECD 401 . The doses applied were 6000 mg/kg body weight in 5 females, 5000 mg/kg body weight in 5 males and 5 females and 2000 mg/kg body weight in 5 females. Mortallity occurred on day 5 for 2 females that were dosed 5000 mg/kg body weight and 2 females that were dosed 6000 mg/kg body weight. The most notable clinical abnormalities observed during the study were decreased activity, wobbly gait, breathing abnormalities, soft/mucoid stools, decreased defecation,decreased food consumption, fecal/urine stain, rough haircoat, hunched posture, ocular discharge, dark material around the facial area and most of the time a gain in weight. Gross internal findings observed in the animals that died included two incidences of abnormal content in the small intestine. No significant gross internal findings were observed at necropsy at the end of the study. Based on this the acute oral LD50 of ISONOX-132 in the male rat was estimated to be > 5000 mg/kg body weight. and in the female rat, the oral LD50 was determined with method litchfield and wilcoxon to be 6662 mg/kg body weight. ISONOX-132 does not need to be classified according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and according toRegulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).
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