5-hept-6-enyloxolan-2-one

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Test dates: Dec. 05, 2012 to Mar. 07, 2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

other: State Enviromnental Protection Administration of China. The Guidelines for the test of chemical (HJ/T 153-2004).

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

Issued on: 24 November 2010

Analytical monitoring:

yes

Details on sampling:

The test solutions were filtering by 0.45µm filter before used. The solutions were analyzed immadiatel, otherwise the samples were stored at 4°C until analysis and must be analysised in two days.
Analysis of the tests solutions at 0h and 96h and 24h 48h and 72h (before and after the renewal) after the start of the test.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION

1313mg was accurately weighed (the purity of the test substance is 99.14%) then repeatedly dissolved in a 500ml beaker with 1L test water, transferred to a 20L flask with a final volume of 13L, the nominal concentration of 100mg /iLstock~solution of thetest substancel was obtained.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Strain: Brachydanio rerio
- Source: Kang Da Farm (Batch number - FBr20121029-1)

ACCLIMATION
- Acclimation period: 36 days
- Acclimation conditions: flow-through under the same conditions of water quality (Dechlorinated tap water), temperature (23 °C ± 2 °C), light and dark period (14h light / 10h dark). The dissolved oxygen concentration during acclimation was kept. at least 80 % of the air saturation value.
- Feeding frequency during acclimation: fed daily until 24 hours before the start of the test
- Health during acclimation: No mortality during 7 days before the start of the test,

FEEDING DURING TEST (as applicable) : The fish were not fed during the exposure.

Test type:

semi-static

Water media type:

other: Dechlorinated tap water

Limit test:

no

Total exposure duration:

96 h

Hardness:

127 mg/L (expressed as CaCO3)

Test temperature:

23 °C ± 2 °C

pH:

8.38

Dissolved oxygen:

≥ 60%

Nominal and measured concentrations:

Nominal concentration: 10.0, 15 .0, 22.5, 33.8 and 50.6 mg/L
Measured concentration: 10.26, 14.68, 21.22, 32.26, 47.52 mg/L

Details on test conditions:

TEST SYSTEM
- 3 L Test vessel
- Aeration: no
- Renewal rate of test solution: Every 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 3
- Biomass loading rate: 0.583 g/L

OTHER TEST CONDITIONS
- Adjustment of pH: No
- LIGHT : Artificial light of white fluorescent lamp,14h light/ 10h darkness
- the fish were not fed during the exposure

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Mortality and visible abnormality of the test fish were recorded at 3h, 24h, 48h, 72h and 96h. The temperature, pH and dissolved oxygen of each test group were measured at 0h, 96h and 24h, 48h, 72h (before and after the renewal).

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

17.6 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% confidence limits: 16.6 mg/L - 18.7 mg/L

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

16.9 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% confidence limits: 15.6 mg/L - 18.2 mg/L

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

16.9 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% confidence limits: 15.5 mg/L - 18.5 mg/L

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

15.7 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% confidence limits: 14.1 mg/L - 17.5 mg/L

Key result

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

22.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

Sensitivity test of K2Cr2O7 with Zebra fish showed thatn the 24h-LC50 of the reference substance was 269 mg/L to zebra fish and the 95% confidence limits was 222 to 344 mg/l.

Sublethal observations / clinical signs:

Mortality

The cumulative mortality of blank control was 0% at the end of the test, which met the criterion for the validity of the test.

The cumulative mortality of 10.0 mg/L, 15 .0 mg/L, 22.5 mg/L, 33.8 mg/L and 50.6 mg/L test groups were 4.8%, 33.3%, 100%, 100% and 100% at the end of the test.

 

Table 6.1.1.1: Cumulative mortality (%)

Nominal concentration (mg/L)	Number of test fish	Cumulative mortality
		3h	24h	48h	72h	96h
Blank control	21	0	0	0	0	0
10.0	21	0	0	0	0	4.8
15.0	21	0	9.5	19	19	33.3
22.5	21	95.2	100	100	100	100
33.8	21	100	100	100	100	100
50.6	21	100	100	100	100	100

 

Observed abnormal response

 

No abnormal response was observed in blank control.

Observed abnormal responses during the test were reduced. activity, overturn and loss of equilibrium, lying on the bottom, spasmodic swimming and pigmentation and so on.

 

Table 6.1.1.2: Observed abnormal response

Nominal concentration (mg/L)	replicate	Result of observation Left column: affected fish / Total fish; Right column: Symptoms
		3h		24h		48h		72h		96h
Blank control	1	0/7	N	0/7	N	0/7	N	0/7	N	0/7	N
	2	0/7	N	0/7	N	0/7	N	0/7	N	0/7	N
	3	0/7	N	0/7	N	0/7	N	0/7	N	0/7	N
10.0	1	7/7	RA (7)	7/7	RA (7)	7/7	DC (1) RA (4) IMM (2)	6/7	RA (6)	7/7	RA (5) AS (2)
	2	7/7	RA (7)	7/7	RA (7)	7/7	RA (7)	6/7	RA (6)	7/7	RA (6) IMM (1)
	3	7/7	RA (7)	7/7	RA (7)	7/7	RA (4) IMM (3)	6/6	RA (6)	6/6	RA (3) IMM (3)
15.0	1	7/7	LB (1) RA (3) IMM (3)	6/6	DC (6) OLE (1)RA (1) IMM (4)	6/6	DC (6) LB (1)RA (1) IMM (4)	6/6	LB (1)RA (2) IMM (3)	6/6	LB (3) IMM (3)
	2	7/7	OLE (2)AS (1) IMM (4)	7/7	DC (7) LB (3) IMM (4)	5/5	DC (5) LB (1) OLE (3)RA (1)	5/5	OLE (5)	4/4	OLE (4)
	3	7/7	AS (1) IMM (6)	6/6	DC (4) RA (3) IMM (3)	6/6	LB (2) OLE (3) IMM (1)	6/6	OLE (5)RA (1)	4/4	OLE (3)RA (1)
22.5	1	1/1	LB (1)	-	-	-	-	-	-	-	-
	2	-	-	-	-	-	-	-	-	-	-
	3	-	-	-	-	-	-	-	-	-	-
33.8	1	-	-	-	-	-	-	-	-	-	-
	2	-	-	-	-	-	-	-	-	-	-
	3	-	-	-	-	-	-	-	-	-	-
50.6	1	-	-	-	-	-	-	-	-	-	-
	2	-	-	-	-	-	-	-	-	-	-
	3	-	-	-	-	-	-	-	-	-	-

Note: “N”: Nornral; “-”: All test fish died; “RA”: Reduced activity; “OLE”: overturn and loss of equilibrium; “LB”: lying on the bottom; “IMM”: Immobilized at the bottom; “DC”: pigmentation.

 

The body weight and length of test fish

 

The body weight and length of 10 test fish in blank control were measured when the test finish. The average and standard deviation of test fish of body weight was 0.250 g ± 0.0269 g and 25.99 mm ± 0.8431 mm of the body length.

 

Measurement of temperature, pH and dissolved oxygen of test solution

 

During the test, the measurement values of pH temperature dissolved oxygen ranged from 7.59 to 8.21, 21.2 °C to 23.8°C and 60% to 102%, respectively. The dissolved oxygen concentrations were kept at least 60 percent of the air saturation value, which met the criterion for the validity of the test.

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the test, the 96h LC50 of test substance (based on the actual concentration) was 15.7 mg/L for Zebra fish (Brachydanio rerio) and the 95% confidence limits is 14.1 mg/L to 17.5 mg/L. The lowest concentration causing 100% mortality at 96h (LC100) was 22.5 mg/L test group.

Executive summary:

The acute toxicity of the test item to zebra fish was conducted according to OECD 203 "Fish acute toxicity test".

 

In an acute aquatic toxicity study performed in accordance with OECD guideline 203 and GLP, groups (21/dose) of zebra fish (Brachydanio rerio) were exposed to test substance at concentrations of 0 (blank), 10, 15, 22.5, 33.8 or 50.6 mg/L (nominal) for 96 hours under semi-static conditions. Mortality and behavioural effects were recorded at 3, 24, 48, 72 and 96 hours. A preliminary range-finding test was also conducted on 5 fish/ dose at 1, 5, 10, 50 or 100 mg/L and animals were observed for 96 hours.

 

Mortalities (96 hour) at 0 (blank), 10, 15, 22.5, 33.8 or 50.6 mg/L were 0, 4.8, 33.3, 100, 100 or 100%, respectively. Abnormal response include Reduced activity, loss of equilibrium and the presence of moribund fish. LC50 values at 24, 48, 72 or 96 hours were calculated to be 17.6 (16.6-18.7), 16.9 (15.6-18.2), 16.9 (15.5-18.5) or 15.7 (14.1-17.5) mg/L, respectively.

 

Under the test conditions, the 96 hour LC50 for test substance is less than 15.7 mg/L in zebra fish (Brachydanio rerio).

Description of key information

OCDE 203, key study, validity 2:

96h-LC50 = 15.7 mg/L (95% CL: 14.1 - 17.5 mg/L).

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

15.7 mg/L

Additional information

To assess the short term toxicity of the registered substance to fish, one data point is available

This value (Guangdong, 2013) is assessed as a key datapoint. The acute toxicity of the test item to zebra fish was conducted according to OECD 203 "Fish acute toxicity test".

 

In an acute aquatic toxicity study performed in accordance with OECD guideline 203 and GLP, groups (7/dose) of zebra fish (Brachydanio rerio) were exposed to test substance at concentrations of 0 (control), solvent control (acetone), 10, 15, 22.5, 33.8 and 50.6 mg/L (nominal) for 96 hours under static conditions. Mortality was recorded at 3, 24, 48, 72 and 96 hours. A preliminary range-finding test was also conducted on 5 fish/ dose at  1.0, 5.0, 10.0, 50.0 and 100.0 mg/L and animals were observed for 96 hours.

 

Mortalities (96 hour) at 0 (control),  10, 15, 22.5, 33.8 or 50.6 mg/L were 0, 4.8, 33.3, 100, 100 or 100%, respectively. LC50 values at 24, 48, 72 or 96 hours were calculated to be be 17.6 (16.6-18.7), 16.9 (15.6-18.2), 16.9 (15.5-18.5) or 15.7 (14.1-17.5) mg/L, respectively. 

 

Under the test conditions, the 96 hour LC₅₀ for test substance is 15.7 mg/L in zebra fish (Brachydanio rerio).