N-hydroxyphthalimide

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Justification for type of information:

Data is from computational model developed by USEPA

Qualifier:

according to guideline

Guideline:

other: Modelling database

Principles of method if other than guideline:

Prediction done using ECOSAR v.1.11 model

GLP compliance:

no

Specific details on test material used for the study:

- Name of the test material: N-Hydroxyphthalimide
- IUPAC name: 2-hydroxy-1H-isoindole-1,3(2H)-dione
- Molecular formula: C8H5NO3
- Molecular Weight: 163.132 g/mol
- Substance type: Organic
- Smiles: c12c(C(=O)N(C1=O)O)cccc2

Analytical monitoring:

not specified

Vehicle:

not specified

Test organisms (species):

other: Fish

Test type:

not specified

Water media type:

freshwater

Total exposure duration:

96 h

Test temperature:

25 Deg.C

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

6 297.041 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: ECOSAR Class:Neutral Organics

Validity criteria fulfilled:

not specified

Conclusions:

Based on the EPI Suite ECOSAR version 1.10 prediction model, the 96 hours LC50 was estimated to be 6297.041 mg/l on Fish for substance 2-hydroxy-1H-isoindole-1,3(2H)-dione (CAS no.524-38-9 ) on the basis of mortality effects.

Executive summary:

The short term toxicity on fish was predicted for test substance 2-hydroxy-1H-isoindole-1,3(2H)-dione (CAS: 524-38-9) using the EPI Suite ECOSAR version 1.10. On the basis of effects observed in a static freshwater system, the lethal concentration LC50 value for the substance is estimated to be 6297.041mg/l for fish for 96 h duration. Based on this value, it can be concluded that the test chemical 2-hydroxy-1H-isoindole-1,3(2H)-dione can be considered as non toxic to fish at predicted concentrations and can be considered to be not classified as per the criteria mentioned in CLP regulation.

Description of key information

The short term toxicity on fish was predicted for test substance 2-hydroxy-1H-isoindole-1,3(2H)-dione (CAS: 524-38-9) using the EPI Suite ECOSAR version 1.10. On the basis of effects observed in a static freshwater system, the lethal concentration LC50 value for the substance is estimated to be 6297.041mg/l for fish for 96 h duration. Based on this value, it can be concluded that the test chemical 2-hydroxy-1H-isoindole-1,3(2H)-dione can be considered as non toxic to fish at predicted concentrations and can be considered to be not classified as per the criteria mentioned in CLP regulation.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

6 297.041 mg/L

Additional information

Four studies including experimental data and predicted report from reliable models for short term fish toxicity endpoint of test chemical 2-hydroxy-1H-isoindole-1,3(2H)-dione (Cas no. 524-38-9) with relevant read across chemicals which are structurally similar to target chemical were summarized as follows:

First prediction using EPI Suite ECOSAR version 1.10 model, for target chemical 2-hydroxy-1H-isoindole-1,3(2H)-dione (CAS: 524-38-9) wherein the short term toxicity on fish was estimated on the basis of effects in a static freshwater system. The lethal concentration LC50 value for the substance was estimated to be 6297.041mg/l for fish for 96 h duration. Based on this value, it can be concluded that the test chemical 2-hydroxy-1H-isoindole-1,3(2H)-dione can be considered as non toxic to fish at predicted concentrations and can be considered to be not classified as per the criteria mentioned in CLP regulation.

Above result is supported by experimental study for read across chemical Phthalimide i.e 1H-isoindole-1,3(2H)-dione (Cas no. 85-41-6). The acute toxicity test of Phthalimide to Oryzias latipes was conducted according to OECD Guideline 203 (Fish, Acute Toxicity Test) at the dose concentration- control, 55.6 mg/L, 100.0 mg/L (nominal concentrations) at 24±1 degreeC test temp., 6.6 - 7.1 pH and 5.1 - 11.0 mg/l (Saturated concentration at 24°C is 8.25 mg/l) dissolved oxygen in semi static freshwater condition for 96 hrs. During experiment the lethal concentration (LC50) was determined to be 100 mg/l with 95% confidence limit of 55.6 ->100 mg/l. Thus it is concluded that the test substance Phthalimide is non toxic to fish and thus not consider for the aquatic classification as per the CLP criteria. (Japan chemicals collborative knowledge database (J-check); 2017)

Data for the same read across (Phthalimide i.e 1H-isoindole-1,3(2H)-dione (Cas no. 85-41-6)) from different source (Spec.Sci.Rep.Fish.No.207, Fish Wildl.Serv., U.S.D.I., Washington, DC:157 p.) indicated that a short term toxicity study to Petromyzon marinus was carried out for 24 hrs. Test was performed under static conditions. After exposure to test animal at dose conc.5 mg/l of test chemical Phthalimide, no mortality effects were observed on fish. Thus, the NOEC value was considered to be 5 mg/l.

A supporting study from authorative data source (HPVIS) of another read across chemical N-Methylphthalimide (2-methyl-1H-isoindole-1,3(2H)-dione-Cas no. 550-44-7) was also reviewed. The acute fish toxicity study conducted according to OECD guideline 203 for chemical N-Methylphthalimide (2-methyl-1H-isoindole-1,3(2H)-dione) on fish species Rainbow trout (Oncorhynchus mykiss). The Rainbow Trout Mortalities (LC50) after a 24, 48, 72 and 96-h exposure to N-Methylphthalimide (2-methyl-1H-isoindole-1,3(2H)-dione) were reported as -

LC50 (48 , 72 and 96h) 110 mg/L (95% CI = 93 - 131 mg/L)

LC50 (24h) 125 mg/L (95% CI = 111 - 140 mg/L)

Thus based on the all available results for acute fish toxicity, it can be considered that the test chemical 2-hydroxy-1H-isoindole-1,3(2H)-dione (Cas no. 524-38-9) is non toxic to fish at environmentally relevant concentrations and can be considered to be not classified as per the criteria mentioned in CLP regulation.