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REACH

pymetrozine (ISO); (E)-4,5-dihydro-6-methyl-4-(3-pyridylmethyleneamino)-1,2,4-triazin-3(2H)-one

EC number: 602-927-1 | CAS number: 123312-89-0

Life Cycle description
Uses advised against

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Administrative data

Link to relevant study record(s)

Reference

Endpoint:: long-term toxicity to aquatic invertebrates
Type of information:: experimental study
Adequacy of study:: key study
Study period:: 02 Nov 1994 to 23 Nov 1994
Reliability:: 1 (reliable without restriction)
Rationale for reliability incl. deficiencies:: guideline study
Qualifier:: according to guideline
Guideline:: EPA OPP 72-4 (Fish Early Life-Stage and Aquatic Invertebrate Life-Cycle Studies)
Version / remarks:: Federal Insecticide, Fungicide, And Rodenticide Act (FIFRA) 72-4, 1992
Deviations:: no
GLP compliance:: yes
Analytical monitoring:: yes
Details on sampling:: Analytical determination of test material concentration (active ingredient) was performed with samples collected from test vessels on days 0, 7, 14, and 21. The samples were stored in 40 mL amber glass vials. Samples or extracts were refrigerated if not analyzed on the day of collection. Samples collected from replicate 1 test vessels on day 0, from replicate 2 vessels on day 7, from replicate 3 vessels on day 14, and from replicate 4 vessels on day 21 were analyzed. The alternate replicate samples were refrigerated for possible later analysis. If the analysis of the primary sample resulted in a value outside the acceptable range (70 to 130% of nominal), the back-up sample was then analyzed and only the results of the back-up samples are reported unless the analysis of the back-up sample resulted in a similar value.
Vehicle:: no
Details on test solutions:: Stock solutions were prepared 6 times during the test by bringing 0.153 g of test substance to a final volume to 1000 mL with deionized water. The test substance was supplied with a diluter that maintained the final test concentrations during the study.
Test organisms (species):: Daphnia magna
Details on test organisms:: TEST ORGANISM
- Common name: Daphnid
- Age of test organisms: <24 hours
Test type:: flow-through
Water media type:: freshwater
Limit test:: no
Total exposure duration:: 21 d
Hardness:: 164 - 168 mg/L as CaCO3
Test temperature:: 19.1 - 20.8 °C
pH:: 7.6 - 8.0
Dissolved oxygen:: 7.8 - 8.9 mg/L
Conductivity:: 540 - 460 µmhos/cm
Nominal and measured concentrations:: - Nominal concentrations: 0.0 mg/L (control), 0.032, 0.060, 0.12, 0.25, and 0.50 mg/L.
- Mean measured concentrations: <0.00250 (Control; LOD), 0.0251, 0.0515, 0.102, 0.234 and 0.462 mg/L. A detailed overview of the measured concentrations over time is presented in 'Any other information on materials and methods incl. tables'.
Details on test conditions:: TEST SYSTEM
- Test vessel: 270 mL glass beakers, 5 cm depth
- Fill volume: 270 mL
- Aeration: Aeration was not required to maintain dissolved oxygen concentrations above acceptable levels.
- Type of flow-through: The test substance was supplied to the test vessels under flowthrough conditions by an intermittent flow proportional diluter. The diluter allowed test media to contact only glass or Teflon® surfaces. The diluter was calibrated before and after the test. During the test the diluter was activated 407 times, resulting in an average of 18 volume additions per 24 hours in each test vessel.
- No. of organisms per vessel: 10
- No. of vessels per concentration: 4
- No. of vessels per control: 4
- Feeding: Daphnids were fed a yeast/trout chow suspension (≈ 5 mg/L) and the freshwater alga, Selenastrum capricornutum (≈ 108 cells/L) at least once per day

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water, hardness adjusted to 160 - 180 mg CaCO3/L
- Alkalinity: 116 - 123 mg/L as CaCO3
- Culture medium different from test medium: Same

OTHER TEST CONDITIONS
- Adjustment of pH: Yes, pH of the test medium was adjusted to 6.5 - 7.0 with phosphoric acid
- Photoperiod: A 16 hour light and 8 hour dark photoperiod was automatically maintained. A 15 minute transition period was provided between dark and light.
- Light quality: White fluorescent lights
- Light intensity: 40 footcandles

WATER QUALITY MEASUREMENTS
Dissolved oxygen (YSI model 57), pH (Beckman model pHI 12), conductivity (Cole Parmer), and temperature (Beckman model pHI 12) were measured and recorded at the beginning of the test and daily thereafter in each test chamber as long as living animals were present in those vessels. The temperature in one vessel was continuously recorded. Hardness and alkalinity were measured in the dilution water weekly during the test.

EFFECT PARAMETERS MEASURED: Survival of first generation daphnids on day 21, sublethal effects, time to first brood, number of young per female, and length and dry weight of surviving daphnids.
The number of surviving adult daphnids and the occurrence of sublethal effects (immobilization) were determined daily during the test. Dead test organisms were removed when first observed. The number of young
produced was determined and recorded daily after the onset of reproduction, and the young were removed from each test vessel at these times. At the termination of the test the surviving adults were removed,
blotted, and measured with a caliper from the apex of the helmet to the base of the spine. They were then dried at approximately 60°C for 72 hours, transferred to a desiccator at room temperature for approximately
48 hours, and individually weighed.

RANGE-FINDING STUDY
A screening test was conducted for 16 days under static renewal conditions. Nominal concentrations of test substance were 0 mg/L (control), 0.005, 0.05, 0.5, 5, and 50 mg/L. Test solutions were renewed on days 6 and 10 of the study. After 16 days of exposure there was at least 90% survival at 0.0 (control), 0.005, and 0.05 mg/L, 15% survival at 0.5 mg/L, and 0% survival at 5 and 50 mg/L. The total number of young produced during the test was 643 for the controls, 614 at .005 mg/L, 641 at 0.05 mg/L, and 0 at 0.5, 5, and 50 mg/L.
Reference substance (positive control):: no
: Key result
Duration:: 21 d
Dose descriptor:: NOEC
Effect conc.:: 0.025 mg/L
Nominal / measured:: meas. (geom. mean)
Conc. based on:: test mat.
Basis for effect:: reproduction
Remarks:: along with mean dry weight and length of adults
Remarks on result:: other: See 'Any other information on results' for an overview of all derived effect values.
Duration:: 21 d
Dose descriptor:: LOEC
Effect conc.:: 0.051 mg/L
Nominal / measured:: meas. (geom. mean)
Conc. based on:: test mat.
Basis for effect:: reproduction
Remarks:: along with mean dry weight and length of adults
Details on results:: A complete overview of the results is presented in 'Any other information on results incl. tables'.
- Control results: There was 98% control survival after 21 days of exposure. Production of young by the first generation daphnids was first observed on day 9 in the control, and first generation control daphnids produced an average of 58.4 young during the 21-day exposure. At the end of the test the control daphnids had an average dry weight of 0.49 mg, and an average length of 3.9 mm.
- Effects of the test substance: The survival of adults was significantly reduced at 0.102, 0.234, and 0.462 mg/L test substance in comparison to the control. Sublethal effects other than a visual size difference (less active than controls) were noted at 0.102, 0.234, and 0.462 mg/L but were not observed after day 7 of exposure and these data were not statistically analyzed. Immobilization was not observed at any tested concentration. The mean number of young per surviving female was significantly lower than the controls at 0.0515, 0.102, 0.234, and 0.462 mg/L test substance. The mean time to first brood was significantly different from the control at 0.102, 0.234 and 0.462 mg/L. The length and dry weight of surviving daphnids were significantly different than the control at 0.0515, 0.102, 0.234, and 0.462 mg/L test substance.
Reported statistics and error estimates:: Survival of first-generation daphnids on day 21, the time to first brood, the number of young per female (computed as the sum of the number of young per female each day), and the mean length and the mean dry weight of surviving daphnids were statistically analyzed. Immobilization of first generation daphnids or their offspring was not observed in test vessels containing the test substance. Sublethal effects, other than immobilization noted earlier in the test, were not observed after day 7 of exposure and were not statistically analyzed.

Results of the toxicity test were interpreted by standard statistical techniques using TOXSTAT 3.3 (Gulley, et.al., 1990). Shapiro-Wilk's test was used to determine that data were normally distributed, and Bartlett's test was used to determine that variances were homogeneous. The assumptions of homogeneity of variance and normality were met in each case and a parametric one-way analysis of variance (ANOVA) followed by Dunnett's or William's test was used to compare treatment to control means. The no observed effect concentration (NOEC) is the highest tested concentration at which a measured biological parameter was not significantly different from the control (alpha= 0.05). The lowest observed effect concentration (LOEC) is the lowest tested concentration at which a measured biological parameter was significantly different than the control. The maximum acceptable toxicant concentration (MATC) is calculated as the geometric mean of the NOEC and the LOEC. Because immobilization was not observed, the 21 day median effective concentration (EC50) was calculated by the probit method (Stephan, 1983) using survival data.
Validity criteria fulfilled:: yes
Remarks:: see 'Any other information on materials and methods incl. tables'
Conclusions:: The 21-day NOEC was 0.0251 mg/L.
Executive summary:: The chronic toxicity of the test substance to the daphnid, Daphnia magna, is determined in a study according to FIFRA 72-4(b) Guideline and in compliance with GLP criteria. The test was conducted for 21 days. The test was conducted with five concentrations of test substance and a dilution water control at 20±2°C. 40 daphnids (10 per replicate) were exposed to each concentration for 21 days under flow through conditions. Nominal concentrations of the test substance were: 0.0 mg/L (control), 0.032, 0.060, 0.12, 0.25, and 0.50 mg/L. Mean measured concentrations after correction for matrix spike recoveries were: 0.0 mg/L (control), 0.0251, 0.0515, 0.102, 0.234, and 0.462 mg/L. Mean measured concentrations of the test substance were used for all calculations. Daphnids used in the test were produced from an in-house culture. They were less than 24 hours old and in good condition at the beginning of the study. The dilution water was dechlorinated tap water adjusted to a hardness of 160 - 180 mg/L. Control survival was 98% after 21 days of exposure and first generation control daphnids produced an average of 58.4 young after 21 days of exposure. water quality parameters were within acceptable limits throughout the testing period. Measured biological endpoints were the survival of first generation daphnids, the time to first brood, production of young by the first generation daphnids, the dry weight and length of first generation daphnids at the conclusion of the test, and first generation sublethal effects. Survival was significantly different from the control at 0.102, 0.234, and 0.462 mg/L. sublethal effects other than a visualsize difference were not observed at the end of the test. Effects noted earlier in the test were not observed after 7 days of exposure. The mean time to first brood was significantly different from the control at 0.102, 0.234 and 0.462 mg/L. The mean number of young per surviving female was significantly lower than the controls at 0.0515 0.102, 0.234, and 0.462 mg/L test substance. The length and dry weight of surviving daphnids were significantly different from the control at 0.0515, 0.102, 0.234, and 0.462 mg/L test substance. The most sensitive biological endpoints when comparisons are made between the treatments of the test substance and the controls are offspring production, weight, and length of surviving first generation daphnids. Based on these findings, the 21-d NOEC was determined to be 0.0251 mg/L.

Description of key information

All available data was assessed and the studies representing the worst-case effects were included as weight-of-evidence studies. Other studies are included as supporting information. The weight-of-evidence studies are considered to be worst-case and were selected for the CSA.

- 21-d NOEC = 0.0251 mg/L in freshwater invertebrates (Daphnia magna), EPA OPP 72-4, Boeri, 1995

Key value for chemical safety assessment

Fresh water invertebrates

Effect concentration:: 0.025 mg/L

Additional information

Table: Overview of available data on long-term toxicity to aquatic invertebrates

Species	Guideline / GLP	Endpoint	Effect value	Comment	Reference
Daphnia magna	EPA OPP 72-4 / GLP	21-d NOEC	0.0251 mg/L	Flow-through regime. Mean measured concentrations were used for the effect values.	Boeri, 1995

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Biological endpoint	Mean measured concentration of the test substance (mg/L)
Biological endpoint	<0.00250	0.0251	0.0515	0.102	0.234	0.462
Percent survival at Day 21	98	98	80	25*	0**	0**
Mean day of first brood	9.8	9.8	10.8	16.0*	>21.0**	>21.0**
Immobilization	NO	NO	NO	NO	NO	NO
Mean young per surviving daphnid	58.4	58	19.8*	3.2*	0.0**	0.0**
Mean dry weight of surviving adults (mg)	0.49	0.52	0.37*	0.29*	--**	--**
Mean length of surviving adults (mm)	3.9	3.9	3.4*	2.9*	--**	--**

Biological endpoint	NOEC (mg/L)	LOEC (mg/L)	MATC (mg/L)	EC50 (mg/L)
First generation survival	0.0515	0.102	0.0725	0.0735
First generation sublethal effects	0.102	>0.102	>0.102	0.0735
Mean time to first brood	0.102	0.234	0.154	---
Number of young produced	0.0251	0.0515	0.036	---
Mean dry weight of first generation	0.0251	0.0515	0.036	---
Mean length of first generation	0.0251	0.0515	0.036	---

Mean measured concentration of the test substance (mg/L)	Replicate	Mean length (mm)	Mean dry weight (mg)
<0.00250 (control)	1	3.9	0.50
	2	4.0	0.52
	3	3.8	0.47
	4	3.9	0.48
0.0251	1	3.9	0.54
	2	3.9	0.53
	3	3.8	0.49
	4	3.9	0.50
0.0515	1	3.3	0.30
	2	3.2	0.32
	3	3.4	0.41
	4	3.5	0.45
0.0102	1	2.9	0.27
	2	3.1	0.40
	3	2.8	0.25
	4	2.7	0.23
0.234	1	--	--
	2	--	--
	3	--	--
	4	--	--
0.462	1	--	--
	2	--	--
	3	--	--
	4	--	--

Mean measured concentration of the test substance (mg/L)	Replicate	Number of live organisms
		Day of exposure
		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21
<0.00250 (control)	1	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	9	9	9	9
	2	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10
	3	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10
	4	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10
0.0251	1	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10
	2	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10
	3	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10	10
	4	10	10	10	10	10	10	10	10	10	10	9	9	9	9	9	9	9	9	9	9	9	9
0.0515	1	10	10	10	10	10	10	10	10	10	10	10	10	10	9	9	9	9	9	9	9	9	9
	2	10	10	10	10	10	10	10	10	10	10	10	10	10	9	9	9	9	9	9	9	9	8
	3	10	10	10	10	10	10	10	10	10	9	9	9	9	9	9	9	9	9	9	9	9	9
	4	10	10	10	9	9	9	9	9	9	8	8	8	8	6	6	6	6	6	6	6	6	6
0.0102	1	10	10	10	9	9	9	8	8	8	8	8	8	8	8	8	8	7	6	5	5	5	5
	2	10	10	10	8	8	6	6	5	5	5	5	5	5	5	5	4	3	3	2	2	2	2
	3	10	10	10	9	9	9	9	9	9	8	8	8	8	7	6	6	5	5	4	4	3	2
	4	10	10	10	9	9	9	6	5	4	3	3	3	2	2	2	1	1	1	1	1	1	1
0.234	1	10	10	10	6	2	1	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2	10	10	10	8	7	3	1	1	1	1	1	1	0	0	0	0	0	0	0	0	0	0
	3	10	10	10	7	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	4	10	10	10	7	4	1	1	1	1	1	1	1	0	0	0	0	0	0	0	0	0	0
0.462	1	10	10	10	6	2	1	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2	10	10	8	5	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	3	10	10	10	3	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	4	10	10	9	7	2	2	2	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0

Mean measured concentration of the test substance (mg/L)	Replicate	Number of affected organisms
		Day of exposure
		0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21
<0.00250 (control)	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
0.0251	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
0.0515	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
	4	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
0.0102	1	0	0	0	0	0	0	0	1	1	3	3	4	4	4	4	5	6	6	5	5	5	5
	2	0	0	0	0	0	0	0	2	2	3	3	3	3	3	3	2	1	1	2	2	2	2
	3	0	0	0	0	0	0	0	3	3	2	3	3	3	5	6	5	4	5	4	4	3	2
	4	0	0	0	0	0	0	3	2	2	1	1	1	0	0	2	1	1	1	1	1	1	1
0.234	1	0	0	0	6	2	1	1	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-
	2	0	0	0	8	7	3	1	1	1	1	1	1	-	-	-	-	-	-	-	-	-	-
	3	0	0	0	7	5	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
	4	0	0	0	7	4	1	1	1	1	1	1	1	-	-	-	-	-	-	-	-	-	-
0.462	1	0	0	2	6	2	1	1	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-
	2	0	0	1	5	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
	3	0	0	2	3	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-
	4	0	0	1	7	2	2	2	1	1	-	-	-	-	-	-	-	-	-	-	-	-	-