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EC number: 258-203-7 | CAS number: 52821-24-6
- 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
Acute toxicity: oral
The acute toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017); to evaluate the toxic effects of administration of 2-(3-hydroxypropyl)-6- [(3-hydroxy propyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No. 52821-24-6) in rat by the oral route. 50% mortality observed at 2956.76 mg/kg bw in treated rats. Therefore, the acute oral median lethal dose (LD50) of 2-(3-hydroxypropyl)-6-[(3-hydroxy propyl)amino]-1H- benz[de]isoquinoline-1,3(2H)-dione in rat was estimated to be 2956.76 mg/kg b.wt.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- Prediction is done using OECD QSAR toolbox version 3.3 and the supporting QMRF report has been attached.
- Qualifier:
- according to guideline
- Guideline:
- other: refer below
- Principles of method if other than guideline:
- Prediction is done using OECD QSAR Toolbox version 3.3
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data available
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- No data available
- Doses:
- No data available
- No. of animals per sex per dose:
- No data available
- Control animals:
- not specified
- Details on study design:
- No data available
- Statistics:
- No data available
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 2 956.76 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality observed
- Mortality:
- 50% mortality observed at 2956.76 mg/kg bw in treated rats.
- Clinical signs:
- other: No data available
- Gross pathology:
- No data available
- Other findings:
- No data available
- Interpretation of results:
- other: not classified based on CLP criteria
- Conclusions:
- The acute toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017); to evaluate the toxic effects of administration of 2-(3-hydroxypropyl)-6-[(3-hydroxy propyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No. 52821-24-6) in rat by the oral route. 50% mortality observed at 2956.76 mg/kg bw in treated rats. Therefore, the acute oral median lethal dose (LD50) of 2-(3-hydroxypropyl)-6-[(3-hydroxypropyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione in rat was estimated to be 2956.76 mg/kg b.wt.
- Executive summary:
The acute toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017); to evaluate the toxic effects of administration of 2-(3-hydroxypropyl)-6 -[(3-hydroxypropyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No. 52821-24-6) in rat by the oral route. 50% mortality observed at 2956.76 mg/kg bw in treated rats. Therefore, the acute oral median lethal dose (LD50) of 2-(3-hydroxypropyl)-6-[(3-hydroxypropyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione in rat was estimated to be 2956.76 mg/kg b.wt. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that 2-(3-hydroxypropyl)-6- [(3-hydroxy propyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No. 52821-24-6) does not exhibit acute toxicity via the oral route.
Reference
The
prediction was based on dataset comprised from the following
descriptors: LD50
Estimation method: Takes average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
((((((((("a"
or "b" or "c" )
and ("d"
and (
not "e")
)
)
and "f" )
and ("g"
and (
not "h")
)
)
and ("i"
and (
not "j")
)
)
and "k" )
and "l" )
and "m" )
and ("n"
and "o" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Imides (Acute toxicity) by
US-EPA New Chemical Categories
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as SN1 OR SN1 >> Iminium Ion
Formation OR SN1 >> Iminium Ion Formation >> Aliphatic tertiary amines
OR SN1 >> Nitrenium Ion formation OR SN1 >> Nitrenium Ion formation >>
Secondary aromatic amine by DNA binding by OECD ONLY
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Direct
Acylation Involving a Leaving group OR Acylation >> Direct Acylation
Involving a Leaving group >> Acetates by Protein binding by OECD ONLY
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as No alert found by DNA binding by
OASIS v.1.3
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as AN2 OR AN2 >> Michael-type
addition on alpha, beta-unsaturated carbonyl compounds OR AN2 >>
Michael-type addition on alpha, beta-unsaturated carbonyl compounds >>
Four- and Five-Membered Lactones OR AN2 >> Schiff base formation OR AN2
>> Schiff base formation >> Dicarbonyl compounds OR AN2 >> Schiff base
formation by aldehyde formed after metabolic activation OR AN2 >> Schiff
base formation by aldehyde formed after metabolic activation >> Geminal
Polyhaloalkane Derivatives OR AN2 >> Shiff base formation after aldehyde
release OR AN2 >> Shiff base formation after aldehyde release >>
Specific Acetate Esters OR AN2 >> Shiff base formation for aldehydes OR
AN2 >> Shiff base formation for aldehydes >> Geminal Polyhaloalkane
Derivatives OR Non-covalent interaction OR Non-covalent interaction >>
DNA intercalation OR Non-covalent interaction >> DNA intercalation >>
Coumarins OR Non-covalent interaction >> DNA intercalation >> DNA
Intercalators with Carboxamide Side Chain OR Non-specific OR
Non-specific >> Incorporation into DNA/RNA, due to structural analogy
with nucleoside bases OR Non-specific >> Incorporation into DNA/RNA,
due to structural analogy with nucleoside bases >> Specific Imine
and Thione Derivatives OR Radical OR Radical >> Generation of reactive
oxygen species OR Radical >> Generation of reactive oxygen species >>
N,N-Dialkyldithiocarbamate Derivatives OR Radical >> Radical mechanism
via ROS formation (indirect) OR Radical >> Radical mechanism via ROS
formation (indirect) >> Coumarins OR Radical >> Radical mechanism via
ROS formation (indirect) >> Geminal Polyhaloalkane Derivatives OR
Radical >> Radical mechanism via ROS formation (indirect) >> Nitro
Azoarenes OR Radical >> Radical mechanism via ROS formation (indirect)
>> Nitroarenes with Other Active Groups OR Radical >> Radical mechanism
via ROS formation (indirect) >> p-Substituted Mononitrobenzenes OR
Radical >> Radical mechanism via ROS formation (indirect) >> Single-Ring
Substituted Primary Aromatic Amines OR Radical >> Radical mechanism via
ROS formation (indirect) >> Specific Imine and Thione Derivatives OR SN1
OR SN1 >> Alkylation after metabolically formed carbenium ion species OR
SN1 >> Alkylation after metabolically formed carbenium ion species >>
Polycyclic Aromatic Hydrocarbon Derivatives OR SN1 >> Nucleophilic
attack after carbenium ion formation OR SN1 >> Nucleophilic attack after
carbenium ion formation >> Specific Acetate Esters OR SN1 >>
Nucleophilic attack after diazonium or carbenium ion formation OR SN1 >>
Nucleophilic attack after diazonium or carbenium ion formation >>
Nitroarenes with Other Active Groups OR SN1 >> Nucleophilic attack after
metabolic nitrenium ion formation OR SN1 >> Nucleophilic attack after
metabolic nitrenium ion formation >> Single-Ring Substituted Primary
Aromatic Amines OR SN1 >> Nucleophilic attack after reduction and
nitrenium ion formation OR SN1 >> Nucleophilic attack after reduction
and nitrenium ion formation >> Nitro Azoarenes OR SN1 >> Nucleophilic
attack after reduction and nitrenium ion formation >> Nitroarenes with
Other Active Groups OR SN1 >> Nucleophilic attack after reduction and
nitrenium ion formation >> p-Substituted Mononitrobenzenes OR SN1 >>
Nucleophilic substitution on diazonium ions OR SN1 >> Nucleophilic
substitution on diazonium ions >> Specific Imine and Thione Derivatives
OR SN2 OR SN2 >> Acylation OR SN2 >> Acylation >> Specific Acetate
Esters OR SN2 >> Acylation involving a leaving group OR SN2 >>
Acylation involving a leaving group >> Geminal Polyhaloalkane
Derivatives OR SN2 >> Acylation involving a leaving group after
metabolic activation OR SN2 >> Acylation involving a leaving group after
metabolic activation >> Geminal Polyhaloalkane Derivatives OR SN2 >>
Alkylation, direct acting epoxides and related after P450-mediated
metabolic activation OR SN2 >> Alkylation, direct acting epoxides and
related after P450-mediated metabolic activation >> Polycyclic Aromatic
Hydrocarbon Derivatives OR SN2 >> Alkylation, nucleophilic substitution
at sp3-carbon atom OR SN2 >> Alkylation, nucleophilic substitution at
sp3-carbon atom >> Sulfonates and Sulfates OR SN2 >> Alkylation, ring
opening SN2 reaction OR SN2 >> Alkylation, ring opening SN2 reaction >>
Four- and Five-Membered Lactones OR SN2 >> Direct acting epoxides formed
after metabolic activation OR SN2 >> Direct acting epoxides formed after
metabolic activation >> Coumarins OR SN2 >> Direct acting epoxides
formed after metabolic activation >> Quinoline Derivatives OR SN2 >> DNA
alkylation OR SN2 >> DNA alkylation >> Vicinal Dihaloalkanes OR SN2 >>
Internal SN2 reaction with aziridinium and/or cyclic sulfonium ion
formation (enzymatic) OR SN2 >> Internal SN2 reaction with aziridinium
and/or cyclic sulfonium ion formation (enzymatic) >> Vicinal
Dihaloalkanes OR SN2 >> Nucleophilic substitution at sp3 Carbon atom OR
SN2 >> Nucleophilic substitution at sp3 Carbon atom >> Specific Acetate
Esters OR SN2 >> Nucleophilic substitution at sp3 carbon atom after
thiol (glutathione) conjugation OR SN2 >> Nucleophilic substitution at
sp3 carbon atom after thiol (glutathione) conjugation >> Geminal
Polyhaloalkane Derivatives OR SN2 >> SN2 at an activated carbon atom OR
SN2 >> SN2 at an activated carbon atom >> Quinoline Derivatives OR SN2
>> SN2 attack on activated carbon Csp3 or Csp2 OR SN2 >> SN2 attack on
activated carbon Csp3 or Csp2 >> Nitroarenes with Other Active Groups by
DNA binding by OASIS v.1.3
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as SN1 AND SN1 >> Iminium Ion
Formation AND SN1 >> Iminium Ion Formation >> Aliphatic tertiary amines
AND SN1 >> Nitrenium Ion formation AND SN1 >> Nitrenium Ion formation >>
Secondary aromatic amine by DNA binding by OECD ONLY
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Non binder, without OH or NH2
group by Estrogen Receptor Binding
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as Non binder, impaired OH or NH2
group OR Non binder, MW>500 OR Non binder, non cyclic structure by
Estrogen Receptor Binding
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OASIS v1.3
Domain
logical expression index: "j"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Direct
acylation involving a leaving group OR Acylation >> Direct acylation
involving a leaving group >> Carbamates OR Acylation >> Ester
aminolysis OR Acylation >> Ester aminolysis >> Amides OR Acylation >>
Ester aminolysis >> Dithiocarbamates OR Acylation >> Ring opening
acylation OR Acylation >> Ring opening acylation >> beta-Lactams OR SN2
OR SN2 >> SN2 Reaction at a sp3 carbon atom OR SN2 >> SN2 Reaction at a
sp3 carbon atom >> Activated alkyl esters and thioesters by Protein
binding by OASIS v1.3
Domain
logical expression index: "k"
Referential
boundary: The
target chemical should be classified as Acylation AND Acylation >>
Direct Acylation Involving a Leaving group AND Acylation >> Direct
Acylation Involving a Leaving group >> Acetates by Protein binding by
OECD ONLY
Domain
logical expression index: "l"
Referential
boundary: The
target chemical should be classified as No superfragment by
Superfragments ONLY
Domain
logical expression index: "m"
Referential
boundary: The
target chemical should be classified as Bioavailable by Lipinski Rule
Oasis ONLY
Domain
logical expression index: "n"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 0.158
Domain
logical expression index: "o"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 2.51
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 956.76 mg/kg bw
- Quality of whole database:
- The data is Klimicsh 2 and from OECD QSAR toolbox version 3.3 (2017).
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Various studies including predicted results from the validated model and experimental study has been investigated for acute oral toxicity to a greater or lesser extent for the test chemical 2-(3-hydroxypropyl) -6 -[(3-hydroxypropyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No. 52821-24-6) along with its structurally similar read across substance 1,3-dioxo-1H-benz(de)isoquinoline-2(3H) butyric acid (Isodibut) (CAS No. 88909-96-0).The predicted data for target chemical 2-(3-hydroxypropyl)-6 -[(3-hydroxypropyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No. 52821-24-6) has been compared with the experimental data (in vivo experiments in rodents i.e. most commonly in rats and mice) for read across substance. The studies are summarized as below:
The acute toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017); to evaluate the toxic effects of administration of 2-(3-hydroxypropyl)-6 -[(3-hydroxypropyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No. 52821-24-6) in rat by the oral route. 50% mortality observed at 2956.76 mg/kg bw in treated rats. Therefore, the acute oral median lethal dose (LD50) of 2-(3-hydroxypropyl)-6-[(3-hydroxypropyl)amino]-1H- benz[de]isoquinoline-1,3(2H)- dione in rat was estimated to be 2956.76 mg/kg b.wt.
Similarly based on the prediction done by using the Danish (Q)SAR Database, the acute toxicity study was estimated to evaluate the toxic effects of administration of 2-(3-hydroxypropyl)-6-[(3-hydroxypropyl) amino]-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No. 52821 -24 -6) in rat by the oral route. 50% mortality observed at 3600.0 mg/kg/day in treated rats. Therefore, the acute oral median lethal dose (LD50) of 2-(3-hydroxypropyl)-6-[(3-hydroxypropyl) amino]-1H-benz[de]isoquinoline-1,3(2H)-dione in rat was estimated to be 3600.0 mg/kg/day.
The above study is supported by the experimental study conducted by Efimov , et al. (1986) (United States Patent Document. #4598081), in which the toxicity of 1,3-dioxo-1H-benz(de)isoquinoline-2(3H) butyric acid (Isodibut) (CAS No. 88909-96-0) was examined by way of experiment performed on rats. Mature animals both male and female, weighting 180 to 220 g (rats) were used for said experiment. 1,3-dioxo-1H-benz(de)isoquinoline-2(3H) butyric acid (Isodibut) was administered perorally. The drug was introduced in the form of a starch suspension through a gastric tube. A total of 36 rats were used in the experiment. Rats were given dosages of 3000 mg/kg bw to 6000 mg/kg bw. The animals were kept under observation for 5 days. The symptoms of the acute lethal poisoning by 1,3-dioxo-1H-benz(de)isoquinoline-2(3H) butyric acid (Isodibut) was characterized by flaccidity, hypodynamia, and lower respiration rhythm. Only a few animals showed a short-time initial excitation. 6-8 hours later the animals laid down on the side, their condition became comatose, followed by death. That is the animals died slowly, as a rule, during the first 24-26 hours. Doses of up to 3000 mg/kg bw caused no deaths but 2 animals died at 3500 mg/kg bw, 1 animal died at 4000 mg/kg bw, 3 animals died at 4500 mg/kg bw, 4 animals died at 5000 mg/kg bw, 4 animals died at 5500 mg/kg bw and 5 animals died at 6000 mg/kg bw. Thus, the acute oral median lethal dose (LD50) of 1,3-dioxo-1H-benz(de)isoquinoline-2(3H) butyric acid (Isodibut) (CAS No. 88909-96-0) in rat was observed to be 4000 (3030 to 5280) mg/kg b.wt. Therefore, according to CLP criteria for acute toxicity rating for the chemicals, it infers that 1,3-dioxo-1H-benz(de)isoquinoline-2(3H) butyric acid (Isodibut) (CAS No. 88909-96-0) does not exhibit acute toxicity via the oral route.
Similarly, the experimental study conducted by Efimov , et al. (1986) (United States Patent Document. #4598081), in which the toxicity of 1,3-dioxo-1H-benz (de)isoquinoline-2(3H) butyric acid (Isodibut) (CAS No. 88909-96-0) was examined by way of experiment performed on white mice. Mature animals both male and female, weighting 18 to 22 g (white mice) were used for said experiment. 1,3-dioxo-1H-benz(de)isoquinoline -2(3H) butyric acid (Isodibut) was administered perorally. The drug was introduced in the form of a starch suspension through a gastric tube. A total of 51 mice were used in the experiment. Mice were treated with 1,3-dioxo-1H-benz(de)isoquinoline-2(3H) butyric acid (Isodibut) at the dosages of 1260, 1500, 2000, 3500, 3750, 4000, 4500, 4750, 5000 and 5250 mg/kg bw orally. The animals were kept under observation for 5 days. The symptoms of the acute lethal poisoning by 1,3-dioxo- 1H-benz(de)isoquinoline-2(3H) butyric acid (Isodibut) was characterized by flaccidity, hypodynamia, and lower respiration rhythm. Only a few animals showed a short-time initial excitation. 6-8 hours later the animals laid down on the side, their condition became comatose, followed by death. It was observed that 3 animals died at 3750 mg/kg bw, 2 animals at 4000 mg/kg bw, 4 animals at 4500 mg/kg bw, 5 animals at 4750 mg/kg bw, 3 animals at 5000 mg/kg bw and 5 animals died at 5250 mg/kg bw. Thus, the acute oral median lethal dose (LD50) of 1,3-dioxo-1H-benz(de)is oquinoline-2(3H) butyric acid (Isodibut) (CAS No. 88909-96-0) in mice was observed to be 3700 mg/kg b.wt. Therefore, according to CLP criteria for acute toxicity rating for the chemicals, it infers that 1,3-dioxo-1H-benz(de)isoquino line-2(3H) butyric acid (Isodibut) (CAS No. 88909-96-0) does not exhibit acute toxicity via the oral route.
So, based on the above mentioned studies for target substance 2-(3-hydroxypropyl)-6 -[(3-hydroxy propyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No. 52821-24-6) and the read across substance 1,3-dioxo-1H-benz(de)isoquinoline-2(3H) butyric acid (Isodibut) (CAS No. 88909-96-0), the median lethal dose (LD50) value was found to be in the range of 2956.76 mg/kg b.wt to 4000.0 mg/kg/day. Thus,on the basis of these LD50 value and by comparing these studies with the criteria of CLP regulation, it infers that the test substance 2-(3-hydroxypropyl)-6 -[(3-hydroxypropyl)amino]-1H-benz [de]isoquinoline- 1,3(2H)-dione (CAS No. 52821-24-6) does not classify as an acute oral toxicant.
Justification for classification or non-classification
Based on the above mentioned studies on 2-(3-hydroxypropyl)-6 -[(3-hydroxypropyl) amino]-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No. 52821-24-6) and to its read across substance 1,3-dioxo-1H-benz(de)isoquinoline-2(3H) butyric acid (Isodibut) (CAS No. 88909 -96 -0), it can be found that LD50 oral value is greater than 2000 mg/kg b.wt. Thus, according to CLP regulation, it infers that the test substance 2-(3-hydroxypropyl)-6 -[(3-hydroxypropyl)amino]-1H-benz [de]isoquinoline-1,3(2H)-dione (CAS No. 52821-24-6) does not classify as an acute oral toxicant.
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