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EC number: 205-502-5 | CAS number: 141-79-7
- 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
Endpoint summary
Administrative data
Description of key information
The acute oral LD50 of Mesityl oxide was greater than 300 but less than 2000 mg/kg body weight (OECD 423). A weight of evidence approach based on pre-guideline studies identified a 4-hr LC50 of 1130 ppm (4530 mg/m3) in rats. The acute dermal LD50 was reported to be 5150 mg/kg for the rabbit.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy
- Age at study initiation: 9-10 weeks
- Weight at study initiation: approx. 200-250 gr
- Fasting period before study: Overnight prior to dosing (Day –1) up to 4 hours after dosing.
- Housing: 5 if 1 sex/cage during acclimatisation; 3 if 1 sex/cage during study
- Diet (e.g. ad libitum): with the exception of the fasting procedure described above
- Water (e.g. ad libitum):
- Acclimation period: aproximately 3-4 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): Approximately 15 to 25 air changes per hour
- Photoperiod (hrs dark / hrs light): Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
IN-LIFE DATES: From: 3-jun-2010 To: 29-jun-2010 - Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 % in water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 and 30 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 3 female animals at 2000 mg/kg
6 female animals at 300 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy performed: yes (including early decedent)
- Other examinations performed: clinical signs, body weight - Statistics:
- None
- Preliminary study:
- A first sub-group of three female animals was dosed at 2000 mg/kg body weight (step 1). The three animals were found dead at 30 minutes, 4 hours after dosing and, the last one, on Day 2. The clinical signs recorded on the day of dosing were: salivation, lachrymation, difficult breathing, lack of consciousness, mucosal reddening. At necropsy examination, no abnormalities were recorded with the exception of a single animal (died between 2 and 4 hours post dose) which showed abnormal, clear content in the stomach.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Mortality:
- 2000 mg/kg: 3/3 animals. The three animals were found dead at 30 minutes, 4 hours after dosing and, the last one, on Day 2
300 mg/kg: 0/6 animals. - Clinical signs:
- other: 2000 mg/kg: salivation, lachrymation, difficult breathing, lack of consciousness, mucosal reddening. 300 mg/kg: lethargy (or, later, hunched posture), reduced activity lachrymation, semiclosed eyes and piloerection. Presence of clinical signs arose at 30
- Gross pathology:
- 2000 mg/kg: no abnormalities were recorded with the exception of a single animal (died between 2 and 4 hours post dose) which showed abnormal, clear content in the stomach.
300 mg/kg: no abnormalities were recorded at post mortem examination. - Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- These results indicate that the test item, Mesityl oxide, has severe toxic effects at 2000 mg/kg while some toxic effect, shortly reversible, were observed following oral administration of a single dose at a level of 300 mg/kg.
The mortality pattern demonstrates the LD50 to be greater than 300 but less than 2000 mg/kg body weight. - Executive summary:
The acute toxicity of Mesityl oxide (purity 99.87%) was investigated after a single oral administration to female Sprague Dawley rats followed by a 14-day observation period (Dose volume: 10 ml/kg; Vehicle:0.5% carboxymethylcellulose acqueous solution). The animals were sacrificed at the end of the observation period and subjected to necropsy examination. A first sub-group of three female animals was dosed at 2000 mg/kg body weight (step 1). The three animals were found dead at 30 minutes, 4 hours after dosing and, the last one, on Day 2. The clinical signs recorded on the day of dosing were: salivation, lachrymation, difficult breathing, lack of consciousness, mucosal reddening. At necropsy examination, no abnormalities were recorded with the exception of a single animal (died between 2 and 4 hours post dose) which showed abnormal, clear content in the stomach. Two sub-groups of three female animals were subsequently dosed at 300 mg/kg body weight (steps 2 and 3). In step 2, the following clinical signs were recorded: lethargy (or, later, hunched posture), lachrymation, semiclosed eyes and piloerection. In step 3, clinical signs were as follows: hunched posture, reduced activity, lachrymation and piloerection. In both steps, presence of clinical signs arose at 30 minutes after dosing. Recovery started from 4 hours after dosing and was completed by Day 2. No toxicologically relevant effects on the body weight gain were observed and no abnormalities were recorded at post mortem examination in these animals. These results indicate that Mesityl oxide, has severe toxic effects at 2000 mg/kg while some toxic effect, shortly reversible, were observed following oral administration of a single dose at a level of 300 mg/kg. The mortality pattern demonstrates the LD50to be greater than 300 but less than 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 300 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Principles of method if other than guideline:
- Pre-guideline study.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Long-Evans
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 70-150g - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass chamber
- Exposure chamber volume: no data
- Method of holding animals in test chamber: no data
- Source and rate of air: 6 l/min
- Method of conditioning air: no data
- System of generating vapours: the compound was introduced by means of a syringe oparating at a constant rate. A heating coil was used to vaporize the undiluted liquid.
- Temperature, humidity, pressure in air chamber: no data - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 4 h
- Concentrations:
- 450, 900, 1800 and 3600 ppm
- No. of animals per sex per dose:
- 6
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 1 130 ppm
- 95% CL:
- 950 - 1 345
- Exp. duration:
- 4 h
- Remarks on result:
- other: 4.53 mg/l
- Mortality:
- 450 ppm, no death
900 ppm, 1 death
1800 ppm, 6 deaths occuring within 24 hours
3600 ppm, 6 deaths during or shorthly after exposure - Clinical signs:
- other: 450 and 900 ppm, mild eye irritation 1800 ppm, moderate eye irritation and marked vasodilatation. 3600 ppm, severe disconfort and pulmonary diffculty, most rats became comatose after 2 hours
- Body weight:
- no data
- Gross pathology:
- no data
- Interpretation of results:
- toxic
- Remarks:
- Migrated information category 3 Criteria used for interpretation of results: other: Regulation (EC) No 1272/2008
- Executive summary:
Hine et al. (1960) determined the 4-hr LC50 in rats to be 1130 ppm.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 4 530 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: publication
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- No data
- Duration of exposure:
- No data
- Doses:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- No data
- Statistics:
- No data
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 5 150 mg/kg bw
- 95% CL:
- > 4 260 - < 8 420
- Mortality:
- No data
- Clinical signs:
- other: No data
- Gross pathology:
- No data
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
- Executive summary:
The acute dermal LD50 was reported to be 5150 mg/kg for the rabbit.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 150 mg/kg bw
Additional information
Oral route
In an OECD 423 study, the acute toxicity of Mesityl oxide (purity 99.87%) was investigated after a single oral administration to female Sprague Dawley rats followed by a 14-day observation period (Dose volume: 10 ml/kg; Vehicle:0.5% carboxymethylcellulose acqueous solution) (Corvaro, 2010a). The animals were sacrificed at the end of the observation period and subjected to necropsy examination. A first sub-group of three female animals was dosed at 2000 mg/kg body weight (step 1). The three animals were found dead at 30 minutes, 4 hours after dosing and, the last one, on Day 2. The clinical signs recorded on the day of dosing were: salivation, lachrymation, difficult breathing, lack of consciousness, mucosal reddening. At necropsy examination, no abnormalities were recorded with the exception of a single animal (died between 2 and 4 hours post dose) which showed abnormal, clear content in the stomach. Two sub-groups of three female animals were subsequently dosed at 300 mg/kg body weight (steps 2 and 3). In step 2, the following clinical signs were recorded: lethargy (or, later, hunched posture), lachrymation, semiclosed eyes and piloerection. In step 3, clinical signs were as follows: hunched posture, reduced activity, lachrymation and piloerection. In both steps, presence of clinical signs arose at 30 minutes after dosing. Recovery started from 4 hours after dosing and was completed by Day 2. No toxicologically relevant effects on the body weight gain were observed and no abnormalities were recorded at post mortem examination in these animals. These results indicate that Mesityl oxide, has severe toxic effects at 2000 mg/kg while some toxic effect, shortly reversible, were observed following oral administration of a single dose at a level of 300 mg/kg. The mortality pattern demonstrates the LD50 to be greater than 300 but less than 2000 mg/kg body weight.
Inhalation
Hine et al. (1960) determined the 4-hr LC50 in rats and mice to be 1130 (4530 mg/m3) and 2000 to 4000 ppm, respectively.
Smyth et al. (1942) found that 12,000 ppm mesityl oxide killed rats and guinea pigs after 1 hr of exposure. Eight-hour exposures of rats to 2500, 1000, and 500 ppm killed 100, 68, and 30 percent of the test animals, respectively.Hart et al. (1939) exposed mice to concentrations of 6000 to 24,000 ppm mesityl oxide in air. Clinical signs of toxicity were ocular and nasal irritation, labored breathing, convulsions, narcosis, vasodilation, cyanosis, and death. The time to death was concentration dependent, and ranged from 23 to 135 min.
Carpenter et al. (1949) subjected groups of six male or female rats to acute 4-hr exposures of increasing concentrations of mesityl oxide until two to four of the animals died within a 14-day observation period. They found that a concentration of 1000 ppm was necessary to produce this mortality.
Dermal route
The acute dermal LD50 was reported to be 5150 mg/kg for the rabbit (Topping et al., 1994).
Justification for selection of acute toxicity – oral endpoint
GLP guideline study
Justification for selection of acute toxicity – inhalation endpoint
Weight of evidence approach
Justification for selection of acute toxicity – dermal endpoint
Only data available. Data from handbook or collection of data
Justification for classification or non-classification
Regulation (EC) No 1272/2008
Annex VI Table 3.1 |
Classification |
Labelling |
|||
Hazard Class |
Hazard Statement |
Pictogram |
Hazard Statement |
Suppl. Hazard |
Acute Tox. 4 * Acute Tox. 4 * Acute Tox. 4 * |
H332 H312 H302 |
GHS07 Wng |
H332 H312 H302 |
Annex VI Table 3.2 |
Classification |
Risk phrases |
Indication(s) of danger |
Xn; R20/21/22 |
20/21/22 |
Xn |
Concentration Limits | |
Concentration | Classification |
C = 5 % |
Xn; R20/21/22 |
Proposed self classification
According to Regulation (EC) No 1272/2008
Classification |
Labelling |
|||
Hazard Class |
Hazard Statement |
Pictogram |
Hazard Statement |
Suppl. Hazard |
Acute Tox. 3 Acute Tox. 4 |
H331 H302 |
GHS06 |
H331 H302 |
According to Directive 67/548/EEC
Classification |
Risk phrases |
Indication(s) of danger |
Xn; R20/22 |
20/22 |
Xn |
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