[No public or meaningful name is available]

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

yes

Remarks:

see below

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Principles of method if other than guideline:

Modifications:
In view of the difficulties associated with the evaluation of aquatic toxicity of poorly water soluble test items, a modification of the standard method for the preparation of aqueous media was performed. In cases where the test item is a complex mixture and is poorly soluble in water, an approach endorsed by several important regulatory authorities in the EU and elsewhere (ECETOC 1996, OECD 2000 and Singer et al 2000), is to expose organisms to a Water Accommodated Fraction (WAF) of the test item.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Details on test solutions:

Due to the low aqueous solubility and complex nature of the test item, for the purposes of the test, the test medium was prepared as a Water Accommodated Fraction (WAF).

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

static

Water media type:

other: Reconstituted Water

Limit test:

no

Total exposure duration:

48 h

Test conditions

Test temperature:

21°C to 22°C

pH:

pH at beginning: 7.7 to 7,8
pH-48h: 7,7 to 7,9

Dissolved oxygen:

Dissolved oxyden at beginning: 8.5 mg O2/L
Dissolved oxyden-48h: 8,8 mg O2/L

Nominal and measured concentrations:

Nominal Loading rate was determined according to a range-finding test: 10, 18, 32, 56, 100 mg/L

Reference substance (positive control):

yes

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Basis for effect:

mobility

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

56 mg/L

Basis for effect:

mobility

Effect concentrations 3

Key result

Duration:

48 h

Dose descriptor:

LOELR

Effect conc.:

100 mg/L

Basis for effect:

mobility

Details on results:

A sub-lethal effect of exposure was observed in the 100 mg/L loading rate WAF test group. The response was trapping at the surface.

Results with reference substance (positive control):

potassium dichromate: EC50, 48h = 1.2 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Daphnia magna 48h EL50 is greater than 100 mg/L loading rate as Water-Accomodated-Fraction (WAF). The NOELR was 56 mg/L loading rate WAF. The LOELR was 100 mg/L loading rate WAF.

Executive summary:

Short-term toxicity to aquatic invertebrates of the test item was evaluated according to OECD Guideline 202 (Daphnia sp., Acute Immobilisation Test). Daphnids (Daphnia magna) were exposed for 48 hours to the water accommodated fraction (WAF) of the test item at nominal loading rates of 10, 18, 32, 56, and 100 mg/L. Exposure of daphnids to the test item gave EL50 values of greater than 100 mg/L loading rate WAF. The no observed effect loading rate (NOELR) was 56 mg/L loading rate WAF, and the lowest observed effect loading rate (LOELR) was 100 mg/L loading rate WAF. This results in the test item being unclassified for short-term toxicity to aquatic invertebrates, according to GHS criteria.