1,3-dihydro-1,3-dioxo-2H-isoindole-2-hexanoic acid

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to internationally accepted guideline. No deviations from guideline protocol.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3-dihydro-1,3-dioxo-2H-isoindole-2-hexanoic acid

EC Number:

224-675-8

EC Name:

1,3-dihydro-1,3-dioxo-2H-isoindole-2-hexanoic acid

Cas Number:

4443-26-9

Molecular formula:

C14H15NO4

IUPAC Name:

6-(1,3-dioxo-2,3-dihydro-1H-isoindol-2-yl)hexanoic acid

Details on test material:

Name of test material (as cited in study report): PAC
Lot/Batch number: 5 A 7990
Specification
Purity: 99.48%
Water solubility: 200 mg/l

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

yes

Details on test solutions:

Daily preparation of a stock solution containing 500 mg/l of substance and 0.01% of methylcellulose, used as solubility coadjuvant agent. Solution made with the aid of an ultrasonic device.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Source: Incontri con la natura, Ciriè (Torino), Italia.
- Age at study initiation (mean and range, SD): no data
- Length at study initiation (length definition, mean, range and SD): 3,5 cm
- Weight at study initiation (mean and range, SD): 0,404 g
- Method of breeding: no data
- Feeding during test: no

ACCLIMATION
- Acclimation period: 1 month
- Acclimation conditions (same as test or not): not stated
- Type and amount of food: Feed JBL-JBL during the acclimation period, amount not stated
- Feeding frequency: daily

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

50 mg CaCO3/L

Test temperature:

23°C

pH:

see table "Test conditions"

Dissolved oxygen:

see table "Test conditions"

Nominal and measured concentrations:

Nominal: 500 mg/L. The treatment solutions were changed every 24 h. The analyses of the actual concentrations were performed at 0 and 24 h of the treatment period, indicating a good correlation between nominal and measured concentrations (less than 10% of variation).
But the data of the analytical measurements are not present in the report.

Details on test conditions:

TEST SYSTEM
- Type: semistatic
- Volume of test vessel: 10 L
- Aeration: no
- Renewal rate of test solution (frequency): daily interval
- No. of organisms per vessel: 10 animals/vessel
- No. of vessels per concentration (replicates): 1 vessel/concentration
- No. of vessels per control (replicates): 1 vessel
- No. of vessels per vehicle control (replicates): 1 vessel

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water from the municipal main system.

OTHER TEST CONDITIONS
- Photoperiod: 12/16h photoperiod daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality

TEST CONCENTRATIONS
- Test concentrations: 500 mg/L (limit test)

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Effect concentrations 4

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

500 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Details on results:

No mortality, no observed adverse effects

Any other information on results incl. tables

Sublethal observations / clinical signs:

Loss in concentration of the test substance over test period: 4.34 %

Validity criteria for acute fish test according to OECD Guideline 203:

	fulfilled	Not fullfilled
Mortality of control animals <10%	YES
Concentration of dissolved oxygen in all test vessels > 60% saturation	YES

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

see above

Conclusions:

No mortality was observed. The substance is not toxic to fish.

Executive summary:

The acute toxicity of PAC in B. rerio was studied by means of a semi-static test. 10 fish/group were exposed to 0 and 500 mg/l PAC in aqueous 0.01% methylcellulose. A further group of 10 fish was exposed to water in the absence of vehicle. The exposure lasted for 96-hours and the solutions were changed every 24 hours. Analyses of the test substance solutions were performed at 0 and 24 hours of the treatment period, indicating a good correlation between nominal and measured concentrations (less than 10% of variation).