4-methyl-salicylamide

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: According to official guidelines and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Type:

Constituent

Test material form:

solid: crystalline

Details on test material:

Identification: V250208
Appearance: Off-white crystals
Batch: F8A
Purity/Composition: >96 %
<3 % 4-methylsalicylacid
<1 % 4-methylsalicylacid-methylester
<0.5 % water
Test item storage: At room temperature protected from light
Stable under storage conditions until: 03 September 2016 (expiry date)
Molecular formula: C8H9NO2
Molecular weight: 151.16

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Frequency: at t=0 h and t=48 h
Volume: 3.0 mL from the approximate centre of the test vessels.
Storage: Samples were stored in a freezer until analysis.

Test solutions

Vehicle:

no

Details on test solutions:

The batch of V250208 tested consisted of off-white crystals with a purity of at least 96% and was not completely soluble in test medium at the loading rate initially prepared.

Preparation of test solutions started with a loading rate of 100 mg/L applying a two (combined limit/range-finding test) or three-day (final test) period of magnetic stirring to ensure maximum dissolution of the test item in the test medium. Afterwards, the test solution was filtered through a 0.45 μm membrane filter (RC55 Whatman) to remove the undissolved fraction. The obtained WSF was used as the highest test concentration. Lower concentrations were prepared by subsequent dilutions of this WSF in test medium. All aqueous solutions were clear and colourless.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Species: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions.
Source: In-house laboratory culture with a known history.
Reason for selection: This system has been selected as an internationally accepted invertebrate species.
Validity of batch: Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
Characteristics: For the test selection of young daphnids with an age of < 24 hours, from parental daphnids of more than two weeks old.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Test temperature:

19 - 20°C

pH:

7.8 - 8.2

Nominal and measured concentrations:

Solutions containing 10, 18, 32, 56 and 100% of the WSF prepared at a loading rate of 100 mg/L.

Analytically results showed that measured concentrations were in agreement with nominal at the start of the exposure (92-94% relative to nominal) and remained stable during the test period (98-99% relative to initial).

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

60 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% confidence interval between 54 and 79 mg/L

Details on results:

The 48h-EC50 was 60 mg/L based on analytically confirmed nominal concentrations (95% confidence interval between 54 and 79 mg/L).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The 48h-EC50 was 60 mg/L based on analytically confirmed nominal concentrations (95% confidence interval between 54 and 79 mg/L).