Sodium 4-(4-substitutedanilino)-4-substituedbut-2-enoate

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

Study period:

08 Jul - 10 Jul 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Standard Concerning Testing Facility Relating to New Chemical Substances

Version / remarks:

March 31, 2011; No. 0331-8, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare; March 29, 2011, No. 6, Manufacturing Industries Bureau, Ministry of Economy, Trade and Industry; No. 110331010, Environmental Policy Bureau, Ministry of the Environment, Japan.

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: control, 100 mg/L
- Sampling method: At the initiation of exposure: an aliquot of remaining unused test solution of each test group was taken; At the termination of exposure: an aliquot was taken from mid-depth of each replicate, without agitation (n = 1)

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 0.0592 g of the test substance was weighed with the electronic balance. A stock solution was prepared by mixing the test substance with the dilution water to make a volume of 100 mL and then stirred for 48 h with a magnetic stirrer at 20 ± 1 °C. The test solution at 100 mg/L was prepared by diluting the whole volume of the stock solution with the dilution water to a volume of 500 mL.
- Eluate: no
- Differential loading: no
- Controls: yes, dilution water

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Source: National Institute for Environmental Studies, Japan
- Feeding during test: no
- Age at study initiation: < 24 h

ACCLIMATION
- Acclimation period: 14 d
- Acclimation conditions: the same as test
- Food type: Commercial condensed live Chlorella -V12 and commercial feed for fish (YCT, suspended yeast, dried alfalfa and Tetramin)
- Amount and frequency: 0.1 - 0.2 mg C (organic carbon)/ daphnid / day
- Health during acclimation: 0 % immobilisation; no abnormalitie were observed.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

250 mg CaCO3/L

Test temperature:

20.0 - 20.1 °C

pH:

7.9 - 8.0

Dissolved oxygen:

8.2 - 8.6 mg/L

Nominal and measured concentrations:

nominal: control, 100 mg/L
measured: control, 105 mg/L

Details on test conditions:

TEST SYSTEM
- Type: covered with lid
- Material, size, headspace, fill volume: glass, 100 mL, headspace: 0 mL, fill volume: 100 mL
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration: 4
- No. of vessels per control: 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: artificial reconstituted water, Elendt M4
- Culture medium different from test medium: no
- Intervals of water quality measurement: at initiation and termination of exposure

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/8 hour dark
- Light intensity: Room lighting = 5.31 - 10.20 μE/m²/s (measured)

EFFECT PARAMETERS MEASURED:
- immoblization after 24 h and 48 h

RANGE-FINDING STUDY
- Test concentrations: 10 and 100 mg/L test substance
- Results used to determine the conditions for the definitive study: yes; no effects were observed in the range-finding study

Reference substance (positive control):

yes

Remarks:

potassium dichromate (at 6-month intervals)

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 105 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Cumulative immobilization of control: 0 %

Results with reference substance (positive control):

- Results with reference substance valid? yes
- EC50 (48 h) = 0.97 mg/L
- Historical EC50 (48 h) = 0.81 ± 0.12 mg/L (mean ± S.D., n = 25)

Any other information on results incl. tables

Table 1. Concentrations of the test substance in the test solutions

Nominal concentration of the test substance (mg/L)	Measured concentration of the test substance (mg/L)
	0 h	48 h	mean
Dilution water control	< 0.15 ^#1	< 0.15 ^#1	-
100	105 [105]	105 [105]	105 [105]

[ ] : Percentage to the nominal concentration ( % )

^#1: less than quantification limit

Applicant's summary and conclusion

Validity criteria fulfilled:

yes