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EC number: 214-046-6 | CAS number: 1074-82-4
- 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
Estimated LD50 was considered to be 2015.7 mg/kg bw when Wistar female rats were treated with 1h-isoindole-1,3 (2h)-dione, potassium salt orally by gavage.
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:
- Data is from QSAR Toolbox 3.3.
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Prediction is done using QSAR Toolbox version 3.3
- GLP compliance:
- not specified
- Test type:
- other: no data
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of the test material: Potassium phthalimide
- Molecular formula: C8H5NO2K
- Molecular Weight: 185.223 g/mole
- Substance type: Organic
- Smiles: c12c(C(=O)[NH-]C1=O)cccc2.[K+] - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- No data available
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- No data available
- Doses:
- 2015.7 mg/kg bw
- No. of animals per sex per dose:
- 3 animals
- Control animals:
- not specified
- Details on study design:
- No data available
- Statistics:
- No data available
- Preliminary study:
- No data available
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 015.7 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50 % mortality observed
- Mortality:
- No data available
- Clinical signs:
- other: No data available
- Gross pathology:
- No data available
- Other findings:
- No data available
- Interpretation of results:
- other: Not Classified
- Conclusions:
- Estimated LD50 was considered to be 2015.7 mg/kg bw when Wistar female rats were treated with 1h-isoindole-1,3(2h)-dione, potassium salt orally by gavage.
- Executive summary:
Based on the prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, acute oral toxicity was estimated in Wistar female rats were treated with 1h-isoindole-1,3(2h)-dione, potassium salt in the concentration of 2015.7 mg/kg bw orally by gavage. LD50 was estimated to be 2015.7 mg/kg bw for Wistar female rats.
Reference
The
prediction was based on dataset comprised from the following
descriptors: LD50
Estimation method: Takes average value from the 8 nearest neighbours
Domain logical expression:Result: In Domain
((((((("a"
or "b" or "c" or "d" or "e" )
and "f" )
and ("g"
and (
not "h")
)
)
and ("i"
and (
not "j")
)
)
and ("k"
and (
not "l")
)
)
and ("m"
and (
not "n")
)
)
and ("o"
and "p" )
)
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 Aryl AND Fused carbocyclic
aromatic AND Fused saturated heterocycles AND Imide by Organic
Functional groups
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Aryl AND Fused carbocyclic
aromatic AND Fused saturated heterocycles AND Imide AND Overlapping
groups by Organic Functional groups (nested)
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Amide, aromatic attach [-C(=O)N]
AND Aromatic Carbon [C] AND Carbonyl, olefinic attach [-C(=O)-] AND
Carbonyl, one aromatic attach [-C(=O)-] AND Miscellaneous sulfide (=S)
or oxide (=O) AND Nitrogen, two or tree olefinic attach [>N-] AND
Olefinic carbon [=CH- or =C<] by Organic functional groups (US EPA)
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Anion AND Aromatic compound AND
Carbonic acid derivative AND Carboxylic acid derivative AND Cation AND
Heterocyclic compound by Organic functional groups, Norbert Haider
(checkmol)
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as Bioavailable by Lipinski Rule
Oasis ONLY
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Group 1 - Alkali Earth
Li,Na,K,Rb,Cs,Fr AND Group 14 - Carbon C AND Group 15 - Nitrogen N AND
Group 16 - Oxygen O by Chemical elements
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as Group 16 - Sulfur S OR Group 17
- Halogens Br OR Group 17 - Halogens Cl OR Group 17 - Halogens
F,Cl,Br,I,At by Chemical elements
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding alerts for skin sensitization by OASIS v1.3
Domain
logical expression index: "j"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Ester
aminolysis OR Acylation >> Ester aminolysis >> Amides OR Michael
Addition OR Michael Addition >> Michael addition on conjugated systems
with electron withdrawing group OR Michael Addition >> Michael addition
on conjugated systems with electron withdrawing group >>
alpha,beta-Carbonyl compounds with polarized double bonds OR
Nucleophilic addition OR Nucleophilic addition >> Addition to
carbon-hetero double bonds OR Nucleophilic addition >> Addition to
carbon-hetero double bonds >> Ketones by Protein binding alerts for skin
sensitization by OASIS v1.3
Domain
logical expression index: "k"
Referential
boundary: The
target chemical should be classified as High gene expression AND High
gene expression >> N-Acylamides by Keratinocyte gene expression
Domain
logical expression index: "l"
Referential
boundary: The
target chemical should be classified as Not possible to classify
according to these rules by Keratinocyte gene expression
Domain
logical expression index: "m"
Referential
boundary: The
target chemical should be classified as H-acceptor-path3-H-acceptor by
in vivo mutagenicity (Micronucleus) alerts by ISS
Domain
logical expression index: "n"
Referential
boundary: The
target chemical should be classified as Polycyclic Aromatic Hydrocarbons
by in vivo mutagenicity (Micronucleus) alerts by ISS
Domain
logical expression index: "o"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -2.36
Domain
logical expression index: "p"
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:
- 2 015.7 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from QSAR Toolbox 3.3
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
Acute oral toxicity:
In different studies, 1h-isoindole-1,3(2h)-dione, potassium salt (CAS no 1074-82-4) has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in vivo estimations in rodents, i.e. most commonly in mice and rats for 1h-isoindole-1,3(2h)-dione, potassium salt along with the study available on structurally similar read across substance phthalimide (CAS no 85-14-6). The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.
Based on the prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, acute oral toxicity was estimated in Wistar female rats were treated with 1h-isoindole-1,3(2h)-dione, potassium salt in the concentration of 2015.7 mg/kg bw orally by gavage. LD50 was estimated to be 2015.7 mg/kg bw for Wistar female rats.
In another prediction done by Danish EPA Model (2017), acute oral toxicity was estimated in mice by using N-potassium phthalimide orally. LD50 was estimated to be 2300 mg/kg bw for mice.
It is further supported experimental data given by J check (2017) on structurally similar read across phthalimide (CAS no 85-14-6), Crj:CD (SD) male and female rats were treated with phthalimide in the concentration of 2000 mg/kg bw in 1 % Carboxymethylcellulose sodium orally to gauge the acute oral toxicity in single dose study. No mortality was observed in treated male and female rats at 2000 mg/kg bw. Similarly, No effects on general appearance and Body weight of treated male and female rats were observed at 2000 mg/kg bw. In addition, No gross pathological and histopathological changes were observed in treated male and female rats at 2000 mg/kg bw Therefore, LD50 was considered to be > 2000 mg/kg bw when rat were treated phthalimide orally by gavage.
In addition to above experimental data study given by OECD SIDS (2005) for similar read across, male and female rats were treated with phthalimide in the concentration of 501, 794, 1260, 2000, 3160, 5000, 7940, 10000 mg/kg bw as a 20% suspension in corn oil orally by gavage. One female died at 10000 mg/kg bw and No mortality was observed in treated male and female rats at 501, 794, 1260, 2000, 3160, 5000, 7940 mg/kg bw. Reduced appetite, reduced activity, and slight lethargy for two to three days were observed in surviving animals. No gross pathological changes were observed in viscera of treated male and female rats. Therefore, LD50 was considered to be > 10000 mg/kg bw when rat were treated phthalimide orally.
Thus based on the above predictions and studies on 1h-isoindole-1,3(2h)-dione, potassium salt and its read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus comparing this value with the criteria of CLP regulation, 1h-isoindole-1,3(2h)-dione, potassium salt can be not classified for acute oral toxicity.
Justification for classification or non-classification
Based on the weight of evidence for target 1h-isoindole-1,3(2h)-dione, potassium salt (CAS no 1074-82-4) and its read across phthalimide (CAS no 85-14-6) is likely to be non hazardous by oral route of exposure.
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