Methyl anthranilate

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

adult fish: sub(lethal) effects

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 EPI Suite

Qualifier:

according to guideline

Guideline:

other: Modeling database

Principles of method if other than guideline:

ECOSAR v1.1

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

other: Fish

Test type:

not specified

Water media type:

not specified

Total exposure duration:

28 d

Key result

Duration:

28 d

Dose descriptor:

LC50

Effect conc.:

7.22 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: other details not available

Validity criteria fulfilled:

not specified

Conclusions:

On the basis of EPI suite, ECOSAR version 1.11, the LC 50 value for long term toxicity to fish was predicted to be 7.22mg/l for test chemical in 28 days.
Based on this value it can be concluded that the substance is non- toxic to aquatic environment and cannot be classified as per the criteria mentioned in CLP regulation.

Executive summary:

Based on the prediction done by EPI suite, ECOSAR version 1.11, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program, the LC 50 value for long term toxicity to aquatic invertebrates was predicted.

On the basis of this program, the LC 50 value for long term toxicity to fish was predicted to be 7.22 mg/l for test chemical in 28 days. Based on this value it can be concluded that the substance is non- toxic to aquatic environment and cannot be classified as per the criteria mentioned in CLP regulation.

Description of key information

Based on the prediction done by EPI suite, ECOSAR version 1.11, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program, the LC 50 value for long term toxicity to aquatic invertebrates was predicted.

On the basis of this program, the LC 50 value for long term toxicity to fish was predicted to be 7.22 mg/l for test chemical in 28 days. Based on this value it can be concluded that the substance is non- toxic to aquatic environment and cannot be classified as per the criteria mentioned in CLP regulation.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

7.22 mg/L

Additional information

Predicted study for target chemical and experimental study for its structurally similar read across chemical have been reviewed to determine the long term toxicity of test chemical to fish and their results are summarized below.

The first study was based on the prediction done by EPI suite, ECOSAR version 1.11, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program, the LC 50 value for long term toxicity to aquatic invertebrates was predicted. On the basis of this program, the LC 50 value for long term toxicity to fish was predicted to be 7.22 mg/l for test chemical in 28 days. Based on this value it can be concluded that the substance is non- toxic to aquatic environment and cannot be classified as per the criteria mentioned in CLP regulation.

Next study was reviewed from Arch. Environ. Contain. Toxicol. in this an experiment was conducted to determine the long term toxicity of test chemical to fish by using 28-day Larval Test. In this test organism used was Oryzias latipes (Japanese Medaka) and it was fed Brine shrimp twice a day during the experiment. The Stock solutions of test chemical were prepared by dissolving test chemical in Lake Superior water, using a high speed stirrer. Stock solutions were transferred to a glass stock bottle inside the vented diluter enclosure using Teflon tubing and air pressure. During each test, a predetermined volume (ml/min) of stock solution was continuously pumped from the stock bottle into the mixing cell of the diluter system. Sampling was done twice weekly and alternately from each complete set of replicate tanks (6 tanks). The analytical monitoring was done by using A Hewlett Packard 5730 A gas chromatograph (GC) equipped with a flame ionization detector (FID) linked to an HP 3350 lab automation system. The experiment was conducted in Continuous-flow mini-diluter exposure systems in Glass aquaria of size 18.5 × 14.0 × 13.0 cm deep. The number of organisms per vessel were 20 and photoperiod of 16 h was given to test organisms. The measured concentration of test chemical were determined to be 0.27 ± 0.07, 0.47 ± 0.16, 0.92 ± 0.33, 1.92 ± 0.45 and 4.85 ± 0.82 mg/Land it control tank it was determined to be <0.25 mg/L. The statistical method used to calculate maximum acceptable test chemical(toxicant) concentrations (MATCs) was one-way analysis of variance with an F-test of significance (p = 0.05) Growth data and normalized hatch and survival data and to subsequent analysis with Dunnett's one-sided comparison (p = 0.05) was used. After exposure of test chemical for 28 days to Oryzias latipes the MATC for test lies between 0.92 and 1.92 mg/L and chronic value was determined to be 1.33 mg/L.

Last study was reviewed from Aquatic Toxicology (1990) in this an experiment was conducted to determine the long term toxicity of test chemical to fish determined by using early life stage (ELS) in which fish are exposed during embryogenesis and larval development. The test organism used in this study was Danio rerio (previous name: Brachydanio rerio).Fertilized eggs of zebra fish (Brachydanio rerio) in the blastula stage were obtained from a stock culture at the TNO laboratory of 50-100 eggs (<6 h after spawning) 40 eggs per concentration were used Upon completion of hatching (4-5 days), the fry were transferred into two vessels per concentration of test chemical. The test solution was prepared by using vehicle DMSO (dimethyl suiphoxide) but the DMSO concentrations were kept below 100 µl/L the ratio between the concentrations was 1.8.DMSO were verified in solvent control experiments. The experiment was conducted in semi-static condition using reconstituted water which was prepared from groundwater obtained from a locality near Linschoten, to which several salts were added at 24 + 2°C temperature. The Photoperiod given was of 12 h. The test solutions were renewed 3 times a week. The analytical monitoring of test chemical was done before and after renewal of the test solutions by using Waters 710B HPLC equipped with a Waters 6000A pump and a Kratos Spectro324 flow UV detector at 220/240 nm and a Guard 30-40/zm precolumn (Chrompack) and a Vydac 201 TPB 5 pm 100 mm × 3 mm column (Chrompack) were used. After 28 days of exposure of test chemical to fish the Differences in mean survival in the experimental concentrations were tested against blank control by means of a χ2 test and the lethal concentration at which 50% mortality (LC50) was observed and NOEC value was determined to be 39 mg/L( 95% confidence (30-51) )and 1.8 mg/L respectively.

By considering results of all the study mentioned above the LC50 value of test chemical was determined to be in range of 1.33 to 39 mg/L after exposure of test chemical for 28 days to fish. By considering range EC50 value it is concluded that test chemical non-toxic to aquatic organisms and cannot be classified as per CLP regulation.