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EC number: 274-581-6 | CAS number: 70356-09-1
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Comparable to guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- limit dose of 16000 mg/kg bw
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 1-[4-(1,1-dimethylethyl)phenyl]-3-(4-methoxyphenyl)propane-1,3-dione
- EC Number:
- 274-581-6
- EC Name:
- 1-[4-(1,1-dimethylethyl)phenyl]-3-(4-methoxyphenyl)propane-1,3-dione
- Cas Number:
- 70356-09-1
- Molecular formula:
- C20H22O3
- IUPAC Name:
- 1-(4-tert-butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione
- Test material form:
- solid
- Details on test material:
- - Name of test material : BMDBM
- Substance type: light yellowish powder
- Physical state: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: W. Gassner, Sulzfeld, Germany
- Weight at study initiation: 90 - 115 g
- Fasting period before study: 16 h
- Housing: 5 animals per Makrolon Type III cage with autoclaved sawdust as bedding
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 4 % w/v aqueous gum arabic solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 40 % w/v as suspension
- Amount of vehicle: 40 mL/kg bw - Doses:
- limit dose of 16000 mg/kg bw
- No. of animals per sex per dose:
- 10 males and 10 females
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequently on the day of dosing and daily thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology (5 males and 5 females of the treated group and all organs with abnormal macroscopic appearance)
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 16 000 mg/kg bw
- Remarks on result:
- other: all animals survived at this dose
- Mortality:
- There were no mortalities in either the treated or control group.
- Clinical signs:
- other: Signs of reaction to treatment, observed shortly after dosing included pitoerection (only in control animals) and abnormal body carriage (hunched posture). These signs were accompanied by slight lethargy immediately after dosing in male rats only.
- Body weight:
- other body weight observations
- Remarks:
- Body weight gains in all treated rats were comparable with those of the control animals throughout the two week observation period.
- Gross pathology:
- Autopsy findings for rats killed at termination were considered to be normal.
- Other findings:
- HISTOPATHOLOGY:
The marked loss of sperm as well as the accumulation of cellular debris in the epididymal tubules of the 5 males examined and the slight vacuolation of hepatocytes (3 male and 2 female animals) may be attributable to treatment with butyl methoxydibenzoylmethane (BMDBM). The testes of all examined animals appeared normal.
Hemosiderin deposits occur commonly in the spleen of rats whereas hemopoiesis in the same organ occurs at a time of stress. Furthermore, the spleen is a hemopoietic organ in the embryo and up some weeks after birth. So indications of spleen hemopoiesis could also be remains of animal development. Unfortunately, no data of control animals were provided for comparison, so that attributing these findings uniquely to BMDBM treatment is not justified. Peribronchial lymphoid hyperplasia and focal interstitial pneumonitis are stages of evolution of chronic murine pneumonia. Small round infiltrates in the liver and focal interstitial nephritis may be considered as a bacterial infection.
Mitotic cells in kidneys, liver, stomach, duodenum, pancreas, adrenals, and epididymis are signs of growing organs.
Any other information on results incl. tables
Table 2: Acute toxicity signs as reaction to treatment with BMDBM
Day |
Control Males |
Control Females |
16000 mg/kg bw Males |
16000 mg/kg bw Females |
1 |
15A |
15A |
15A / 21A / 1A |
15B / 21A |
15A |
15A |
15A |
15B |
|
15A |
15A |
15A |
15B |
|
2 |
15A |
15A |
15A |
15B |
3 |
15A |
15A |
15A |
15B |
4 |
N |
N |
N |
15A |
5 |
N |
N |
N |
N |
6-14 |
N |
N |
N |
N |
Signs of toxicity coding: 1. Lethargy, 15. Piloerection, 21. Hunched posture
Degree of reaction: A = slight, B = Moderate, C = Severe, N = No abnormalities detected
Table 3: Body weight gains of rates dosed once with BMDBM
Group |
Sex |
Bodyweight [g]a) |
Bodyweight gain [g] |
||
Day 1 |
Day 8 |
Day 15 |
|||
Control |
Male |
108 |
167 |
214 |
106 |
Female |
99 |
152 |
178 |
79 |
|
16000 mg/kg bw |
Male |
106 |
166 |
218 |
112 |
Female |
101 |
151 |
175 |
74 |
a)Average of 10 animals per group per sex
Table 4: Autopsy findings after acute oral toxicity study with BMDBM
Group |
Sex |
Organs examined |
Autopsy findings |
Control |
Male |
As listed in table 1 |
Within normal limits |
Female |
As listed in table 1 |
Within normal limits |
|
16000 mg/kg bw |
Male |
As listed in table 1 |
Within normal limits |
Female |
As listed in table 1 |
Within normal limits |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After oral administration of 16000 mg/kg bw of BMDBM as suspension in 4 % gum arabic in water w/v to male and female rats, no mortality was observed.
- Executive summary:
Oral application of a suspension containing 16000 mg/kg bw by gavage to male and female rats resulted in no mortality within 14 days of post-observation. Also vehicle-treated animals showed no mortality. Both groups exhibited clinical signs in the first 4 days after treatment of which the most abundant was piloerection; the animals treated with BMDBM but not the controls showed signs of lethargy and hunched posture. Body weights and gross necropsy were in normal limits in all animals. Histopathological changes were observed mainly in the epididymes and spleen of treated animals, but no causal connection could be developed as animals suffered from a bacterial infection and pneumonia.
Taken together, the test item BMDBM has a LD50 (rat, oral) of >16000 mg/kg bw and therefore does not need to be classified under GHS and CLP.
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