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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 May 2018 - 15 November 2018
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
13 April 2004
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Test item information
Identification: Photomer 4250
Appearance: Colourless to pale yellow liquid
Batch: 17C13003
Purity/Composition: UVCB
Test item storage: At room temperature protected from light
Stable under storage conditions until: 14 March 2019 (expiry date)

For Certificate of Analysis see Appendix 4.

Additional information
Test Facility test item number: 209236/A
Purity/Composition correction factor: No correction factor required
Analytical monitoring:
yes
Details on sampling:
Samples for possible analysis were taken from all test concentrations and the control according to the schedule below.
Frequency at t=0 h and t=48 h
Volume 2.0 mL from the approximate centre of the test vessels
Storage Not applicable, samples were transferred to the analytical laboratory at the Test Facility and analysed on the day of sampling.
At the end of the exposure period, the replicates were pooled at each concentration before sampling.
Vehicle:
no
Details on test solutions:
The batch of Photomer 4250 tested was a colourless to pale yellow liquid mixture and not completely soluble in test medium at the loading rates initially prepared. No correction was made for the purity/composition of the test item. The preparation of test solutions was performed under dimmed light.

Preparation of test solutions started with loading rates individually prepared at 1.0 to 100 mg/L. A 68-minute period of magnetic stirring was applied to ensure maximum dissolution of the test item in test medium. The obtained mixtures were allowed to settle for a period of one hour. Thereafter, the aqueous Water Accommodated Fractions (WAFs) were collected by means of siphoning and used as test concentrations. All test solutions were clear and colorless at the end of the preparation procedure.
Test organisms (species):
Daphnia magna
Details on test organisms:
Species: Daphnia magna (Crustacea, Cladocera) (Straus, 1820), at least third generation, obtained by a cyclical 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 ordiscoloured animals and there was no delay in the production of the first brood.
Characteristics: Daphnia, less than 24 hours old, from parental daphnids of more than two weeks old.
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Post exposure observation period:
Not applicible
Test temperature:
20-21 °C
pH:
7.8-9.1
Dissolved oxygen:
>=3mg/ml
Salinity:
NA
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 27 mg/L
Nominal / measured:
meas. (initial)
Conc. based on:
other: WAF
Basis for effect:
mobility
Details on results:
Samples taken from all test concentrations and the control were analysed. The measured concentrations at the start of the test were 0.36, 2.8 and 27 mg/L in WAFs prepared at loading rates of 1.0, 10 and 100 mg/L, respectively. During the exposure period, the concentrations remained stable, i.e. were at 85-88% relative to the initial concentrations at the end of the test.

Based on these results, the initially measured concentrations were used to express the effect parameters. It should be noted that a relatively high test item concentration was detected in the control at the end of the test. The source of this could not be identified. Considering the problems encountered during the chemical analysis, and that no effect were observed in the control throughout the test, it is assumed that the contamination likely occurred during sampling or sample treatment and thus had no effect on the test results and interpretation.

No immobility was observed in the control and the two lowest test concentrations throughout the exposure period. At the highest test concentration, 0 and 30% immobility were observed after 24 and 48 hours of exposure, respectively.

The responses recorded in this test allowed for reliable determination of an EC50

Number of Introduced Daphnids and Incidence of Immobility

Time (h) Replicate Photomer 4250; Loading rate (mg/L)
Control 1.0 10 100
0 A 5 5 5 5
B 5 5 5 5
C 5 5
D 5 5
Total introduced 20 10 10 20

24 A 0 0 0 0
B 0 0 0 0
C 0 0
D 0 0
Total immobilised 0 0 0 0
Effect % 0 0 0 0

48 A 0 0 0 1
B 0 0 0 2#
C 0 2
D 0 1
Total immobilised 0 0 0 6
Effect % 0 0 0 30
# Microscopic observation revealed no test item attached to the daphnids.
Validity criteria fulfilled:
yes
Conclusions:
In conclusion, the 48h-EC50 for Daphnia magna exposed to Photomer 4250 was beyond the range of concentrations tested, i.e. exceeded a measured concentration of 27 mg/L being considered to be the maximum solubility of the test item in test medium at a loading rate of 100 mg/L.
Executive summary:

The objective of the study was to evaluate Photomer 4250 for its ability to generate acute toxic effects on the mobility of Daphnia magna during an exposure period of 48 hours and, if possible, to determine the EC50 at 24 and 48 hours of exposure.

The study procedures described in this report were based on the OECD guideline No. 202, 2004. In addition, procedures were based on the test methods described in the OECD series on testing and assessment number 23, 2000.

The batch of Photomer 4250 tested was a colourless to pale yellow liquid mixture and not completely soluble in test medium at the loading rates initially prepared.

Water Accommodated Fractions (WAFs) were individually prepared at loading rates ranging between 1.0 and 100 mg/L and used as test concentrations.

A combined limit/range-finding test was performed. Twenty daphnids per group (5 per replicate, quadruplicate) were exposed to an untreated control and to a WAF prepared at a loading rate of 100 mg/L, in a limit test. In addition ten daphnids per group (5 per replicate, duplicate) were exposed to WAFs individually prepared at loading rates of 1.0 and 10 mg/L in the combined range-finding test. The total exposure period was 48 hours and samples for analytical confirmation of exposure concentrations were taken at the start and at the end of the test. Due to the test item being sensitive to light, the test was performed in the dark.

Samples taken from all test concentrations and the control were analysed. The measured concentrations at the start of the test were 0.36, 2.8 and 27 mg/L in WAFs prepared at loading rates of 1.0, 10 and 100 mg/L, respectively. During the exposure period, the concentrations remained stable, i.e. were at 85-88% relative to the initial concentrations at the end of the test. Based on these results, the initially measured concentrations were used to express the effect parameters.

No immobility was observed in the control and the two lowest test concentrations throughout the exposure period. At the highest test concentration, 0 and 30% immobility were observed after 24 and 48 hours of exposure, respectively.

The study met the acceptability criteria prescribed by the study plan and was considered valid.

In conclusion, the 48h-EC50 for Daphnia magna exposed to Photomer 4250 was beyond the range of concentrations tested, i.e. exceeded a measured concentration of 37 mg/L being considered to be the maximum solubility of the test item in test medium at a loading rate of 100 mg/L.

Description of key information

Category Chronic 4

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
27 mg/L

Additional information