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EC number: 404-360-3 | CAS number: 119313-12-1 CG 25-369; IRGACURE 369; TK 11-319
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: assessment
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: toxicokinetics assessment was completed according to ECHA Guidance on information requirements and chemical safety assessment, Chapter R.7c, R.7.12 Guidance on Toxicokinetics (November 2012, version 1.1)
Data source
Reference
- Reference Type:
- other: assessment
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ECHA Guidance on information requirements and chemical safety assessment, Chapter R.7c, R.7.12 Guidance on Toxicokinetics (November 2012, version 1.1)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
- EC Number:
- 404-360-3
- EC Name:
- 2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
- Cas Number:
- 119313-12-1
- Molecular formula:
- C23H20N2O2
- IUPAC Name:
- 2-benzyl-2-(dimethylamino)-1-[4-(morpholin-4-yl)phenyl]butan-1-one
- Test material form:
- other: crystal
Constituent 1
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Oral absorption: the substance is a moderate molecular compound and is not readily soluble in water. It does not contain hydrolysable groups. Tthe substance as such has a low potential to hydrolyse in the dark. However, as it is a photoinitiator, it would be expected to rapidly degrade in the environment upon exposure to nature light.
Although some unspecific symptoms of intoxication were observed in the acute oral toxicity study (reversible within 10 days in all of the animals), the test result LD50 > 5000 mg/kg bw/day indicated that no signs of systemic toxicity were present. System effects observed in the repeated dose toxicity study (28 day) showed oral absorption took place. Since the substance has low water solubility and relatively large particle size, it is estimated that oral/GI absorption is low.
Respiratory absorption: since the substance has low water solubility, relatively large particle size, low volatility and low vapour pressure, respiratory absorption is anticipated to be low.
Dermal absorption: although some unspecific symptoms of intoxication (reversible within 8 days in all animals) were observed in the acute dermal toxicity study, the test result LD50 > 2000 mg/kg bw/day indicated that no signs of systemic toxicity is present. In skin sensitisation (GPMT) test, erythema was observed in one of the four animals in the pre-test (during 24 h after the occlusive application of 30% of the test substance in Vaseline). Due to limited information, it is difficult to assess further. Thanks to its low vapour pressure and log P value of 2.9, it is anticipated that the substance has dermal absorption. However, the dermal absorption could be low because of its low water solubility. - Details on distribution in tissues:
- In both acute oral and dermal toxicity studies, some unspecific symptoms of intoxicaiton were observed, which were reversible within 8-10 days in all animals. System effect such as liver and kidney effects were observed in 28-day oral toxicity study. Based on these observations, the substance could be considered to have transported. Considering its low water solubility and log P value of 2.91, it is estimated that distribution of the substance is low. Not being a lipophilic substance, the substance would be unlikely to accumulate with the repeated intermittent exposure patterns normally encountered in the workplace but may accumulate if exposures are continuous. There is no evidence to indicate substance will accumulate in fat or in other tissues.
- Details on excretion:
- The 28-day oral toxicity study noted the urine effect as follows: urine analysis revealed an increased number of epithelia in the sediment as well as a slightly increased incidence of reducing substances in the urine in the high-dose group, particularly among the males. These findings were reversible.
In comparison to characteristics favourable for urinary excretion, it is estimated that the urine effect in 28-day oral toxicity study is an adaptable change as a result of excretion of metabolism of the substance.
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- No metabolism studies on the substance could be found in the literature.
The 28-day oral toxicity study indicated that in the high-dose group there was a slight anaemia which proved to be completely reversible within the follow-on observation period. In the same dose group some clinico-chemical parameters differed from the control values. Although these changes were not statistically significant, they were assessed as being substance-related. After the end of the follow-on observation period these differences could no longer be measured. Based on the changes above, the substance is expected to be metabolised.
Applicant's summary and conclusion
- Conclusions:
- System effects which were observed in the repeated dose toxicity study (28 day, oral) showed oral absorption took place. Since the substance has low water solubility and relatively large particle size, it is estimated that oral/GI absorption is low. Respiratory and dermal absorption are anticipated to be low.
There are no metabolism studies available. Based on the changes in blood chemistry and different clinico-chemical parameters in the 28-day oral toxicity study, the substance is expected to be metabolised. Urine effect of excretion for the substance was noted .
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