4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

other: Commission Regulation (EC) No 440/2008 of 30 May 2008, Part C: Methods for the determination of ecotoxicity, Publication No. L142, C.1. "Acute Toxicity for Fish".

Qualifier:

according to guideline

Guideline:

other: Guidance document on aquatic toxicity testing of difficult substances and mixtures, OECD series on testing and assessment number 23, December 14, 2000.

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Identification: Kephalis
Appearance: Pale yellow liquid
Batch: PE00097828
Purity/Composition: 85.2% (sum of two peaks)
Test substance storage: In refrigerator (2-8°C) protected from light
Stable under storage conditions until: a14 March 2015 (expiry date)
Chemical name (IUPAC): 4-(1-ethoxyvinyl)-3,3,5,5,-tetramethylcyclohexanone (main component)
CAS Number: 36306-87-3
EC Number: 252-961-2
Molecular formula: C14H24O2
Molecular weight: 224.4 g/mol

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

Kephalis: Solutions containing 4.6, 10, 22, 46 and 100% of the SS prepared at a loading rate of 100 mg/l.
Control: Test medium without test substance or other additives

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Species: Carp (Cyprinus carpio, Teleostei, Cyprinidae) Linnaeus, 1758

Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands.

Mean length:
Range-finding test: 2.1 ± 0.2 cm
Final test: 2.3 ± 0.1 cm

Mean weight:
Range-finding test: 0.24 ± 0.06 g
Final test: 0.31 ± 0.05 g

Characteristics: F1 from a single parent-pair bred in UV-treated water.

Reason for selection: This system has been selected as an internationally accepted species.

Total fish used: 54

Test type:

semi-static

Water media type:

freshwater

Total exposure duration:

96 h

Remarks on exposure duration:

Semi-static, with one renewal of test solutions (48 hours)

Hardness:

Adjusted ISO medium with a hardness of 180 mg CaCO3 per litre

Test temperature:

20-24°C

pH:

pH: 6.0-8.5

Dissolved oxygen:

oxygen > 60% of air saturation

Nominal and measured concentrations:

Nominal: 4.6, 10, 22, 46 and 100% of a saturated solution
Measured: 2.6, 5.9, 14, 198 and 53 mg/L

Reference substance (positive control):

yes

Remarks:

pentachlorophenol (PCP); WIL Research Europe Project 508111 (Batch K 14-06)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

5.9 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

9.1 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% confidence interval could not be determined

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

14 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Results with reference substance (positive control):

The study procedure described in this report was based on the OECD guideline No. 203, 1992.
This reference test was carried out to check the sensitivity of the test system as used by WIL Research Europe. The reference substance was pentachlorophenol (PCP, SIGMA, Art. P2604, Batch MKBK1499V).
Concentrations: 0.10, 0.22 and 0.46 mg/l in ISO-medium.
During the test the pH, oxygen concentration and the temperature of the medium were within the optimal ranges for fish.
Under the conditions of the present test PCP induced no lethal effects in carp at 0.10 mg/l. The
96h-LC50 for carp exposed to PCP was 0.32 mg/l. This effect was already reached within 48 hours of exposure.
The range of the 96h-LC50 for carp is generally between 0.10 and 0.46 mg/l based on historical data of reference tests performed approximately every 3 months from April 1988 until the end of 2000, and annually since then. Hence, the sensitivity of carp originating from the present batch for PCP falls within the range of sensitivities generally observed during the past years.
The raw data and report from this study are kept in the WIL Research Europe archives. The test described above was performed under GLP-conditions with a QA-check.

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the present study the 96h-LC50 was 9.1 mg/l (95% confidence interval could not be determined).

Description of key information

The acute toxicity of the test item to Carp has been investigated and based on the mean measured test concentrations gave a 96-Hour LC50 value of 9.1 mg/l (95% confidence interval could not be determined). The study was performed according to GLP and OECD Guideline 203.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

9.1 mg/L

Additional information

Based on the results of a range-finding test, the definitive test was conducted at test concentrations of 4.6, 10, 22, 46 and 100% of a saturated solution prepared at a loading rate of 100 mg/L. The test was performed under semi-static conditions for 96 hours. Test solutions were renewed after 48 hours.

Samples for analysis of test concentrations were taken at the start and at the end of both refreshment periods or at the time when all fish in a given concentration were found dead. Because Kephalis was light sensitive and volatile, the exposure took place under dimmed light conditions and in airtight closed vessels with headspace reduced to minimum.

Based on the analytical results, the average exposure concentrations were calculated to be 2.6, 5.9, 14, 19 and 53 mg/l in solutions corresponding respectively to the 4.6, 10, 22, 46 and 100% SS. The study met the acceptability criteria prescribed by the protocol and was considered valid.