Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

The target substance is a mono-constituent organotin substance that consists of a tin as central metal element with two octyl-ligands. The source substance Dioctyltin oxide (DOTO) (EC Number 212-791-1 and CAS 870-08-6) is also an organotin compound that has the identical structure elements as the target substance in respect of the tin-alkyl moiety.
According to WHO IPCS CIRCAD (2006) organotin compounds are characterized by a tin–carbon bond and have the general formula RxSn(L)(4−x), where R is an organic alkyl or aryl group and L is an organic (or sometimes inorganic) ligand. The organotin moiety is significant toxicologically. The anionic ligand influences physicochemical properties but generally has little or no effect on the toxicology.
Since the target substance and the source substances share the identical organotin moiety, and the organotin moiety is generally recognized as the relevant toxophore of organotins and the toxicity estimates (AE) respectively toxicity limits for organotins are expressed as tin, the overall ecotoxicity/systemic toxicity of the target can be interpolated by assessing the (eco-)toxicity of the source (WHO IPCS CIRCAD, 2006, BAUA AGS TRGS 900, 2014, Summer KH, Klein D and Greim H, 2003).
The purity of the source and target substance are expected to be similar, based on the manufacturing method. The impurity profile is not expected to have strong effects on substance properties and any impurity of (eco-)toxicological relevance of the source substances is expected to be present in the target substance. Consequently, the hazard profiles of the source substances, including those of their impurities, are intrinsically covered. Differences in impurities are not expected and thus do not have an impact on the (eco-)toxic properties.

References
BAUA (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin (Federal Institute for Occupational Safety and Health)) AGS (Ausschuss für Gefahrstoffe (Committee on Hazardous Substances)) TRGS (Technical Rules for Hazardous Substances) 900 (2014). Begründung zu n-Octylzinnverbindungen, April 2014.
Summer KH, Klein D, Griem H (2003). Ecological and toxicological aspects of mono- and disubstituted methyl-, butyl-, octyl-, and dodecyltin compounds - Update 2002. GSF National Research Center for Environment and Health, Neuherberg, for the Organotin Environmental Programme (ORTEP) Association.
World Health Organization (WHO) International Programme on Chemical Safety (IPCS) Concise International Chemical Assessment Document (CICAD) 73 Mono- and disubstituted methyltin, butyltin, and octyltin compounds (2006). Published under the joint sponsorship of the United Nations Environment Programme, the International Labour Organization, and the World Health Organization, and produced within the framework of the Inter-Organization Programme for the Sound Management of Chemicals

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.09 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: LC50 of the test material is greater than the limit of solubility of the test substance. Aqueous solubility of the test material is between 0.05 and 0.18 mg/L

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 October 2002 to 13 December 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The study was performed to GLP and in line with the standardised guidelines OECD 203 and EU method C.1 with no deficiencies thought to influence the accuracy of the presented results. The study was reported to a high standard. Since the test material DOTO (di-n-octyltin oxide) is in the same category of substances as the registration substance it is considered acceptable to use a read-across approach to address this endpoint.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material:
PHYSICO-CHEMICAL PROPERTIES
- Melting point: melting with decomposition from approximately 282 °C
- Vapour pressure: 0.00042 Pa at 25 °C
- Water solubility (under test conditions): <0.0000152 g/L at 20 °C
- Log Pow: Calculated estimate of 9.26 (method not validated for this class of material)

OTHER PROPERTIES (if relevant for this endpoint)
- Results of test for ready biodegradability: not readily biodegradable
- Results of short-term toxicity testing on invertebrates (Daphnia magna): 48 hour EC50 >water solubility under the conditions of the study (between 0.09 and 0.54 mg/L); EC50 >0.21 mg/L (geometric mean of the solubility of the test material).
- Results of growth inhibition study on algae (Desmodesmus subspicatus): 72 hours ErC50 >0.0018 mg/L; the test material exhibited little or no difference on the growth rate of the algae, the ErC50 of the test material is considered to be greater than the water solubility.

Analytical monitoring:

yes

Details on sampling:

- Sampling method: In duplicate, samples of the newly prepared (clean) control medium and the newly prepared (clean) exposure medium were taken at t = 0 h and t = 48 h. Two of the same spent media were sampled again at 24 h and 72 h. 100 mL samples were collected in 125 mL Nalgene bottles. One set of samples was transferred to the analytical laboratories immediately after sampling. All other samples were stored in a freezer.
- Sample storage conditions before analysis: <-18 °C

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 0.3 g of test material was weighed and transferred to an Erlenmeyer flask with a tap at the bottom. An aliquot of 3 litres of DSWL-E was added and the contents of the flask was stirred for 16 hours followed by 6 hours standing and 2 hours aeration. The aqueous phase was tapped off and the aerated for 2 hours.
- Controls: DSWL-E was used as a control

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Length at study initiation : 2.7 ± 0.20 cm
- Weight at study initiation : 0.17 ± 0.046 g
- Feeding during test The fish were not fed during the test

ACCLIMATION
- Acclimation conditions (same as test or not): The fish were cultured under the same conditions as the test

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

209 mg/L

Test temperature:

24 ± 1 °C (23.0-24.2 °C measured in the control aquarium)

pH:

7.8-8.2

Dissolved oxygen:

Lowest value measured: 7.5 mg O2/L

Nominal and measured concentrations:

A water soluble fraction was prepared for the performance of the test. 0.04-0.18 mg/L of the test material were measured using ICP-AES analysis.

Details on test conditions:

TEST SYSTEM
- Test vessel: Beakers
- Type : closed (covered with a watch glass)
- Material, size, headspace, fill volume: 2 L, all glass
- Aeration: The vessels were not aerated during the test
- Renewal rate of test solution (frequency): The exposure media were replaced after 24 hours.
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The groundwater was obtained from a locality near Linschoted (the Netherlands), HYDRON Medden Nederlan NV Utrecht, the Netherlands.
- Total organic carbon: 1.55 mg/L
Composition:
6.05 mg/L CO2
164 mg/L Hydrocarbon dioxide
< 2 mg/L Carbonate
<1 mg/8.03 mg/L Silicate
0.004 mg/L Manganese
0.069 mg/L Fluoride
<1 mg/L Sulphate
1.22 mmol/L Na^+
0.20 mmol/L K^+
1.38 mmol/L Ca2^2+
0.71 mmol/L Mg^2+
2.81 mmol/L Cl^-
0.65 mmol/L SO4^2-
1.39 mmol/L HCO3^-
46.25 µmol/L B
1.82 µmol/L Mn
7.22 µmol/L Li
0.59 µmol/L Rb
0.57 µmol/L Sr
0.16 µmol/L Br
0.26 µmol/L Mo
0.10 µmol/L Cu
0.10 µmol/L Zn
0.04 µmol/L Co
0.02 µmol/L I
0.01 µmol/L Se
0.05 µmol/L V
0.36 µmol /L Fe
0.67 µmol/L Na2EDTA
- Conductivity: 26.7 Ms.m^-1
- Culture medium different from test medium: Culture medium was the same used in the test

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Dead and living animals were counted after 3, 24, 48, 72 and 96 hours. The condition (swimming behaviour, colour or any other visual behavioural or morphological abnormalities) were assessed at the same time as mortality observations and compared with the control animals.

TEST CONCENTRATIONS
- Range finding study: The results of the range finding test indicated that no adverse effects were expected within the water solubility of the test material. Therefore the test was carried out using a limited test prepared as the WSF (water soluble fraction) of the test material.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.09 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: LC50 of the test material is greater than the limit of solubility of the test substance. Aqueous solubility of the test material is between 0.05 and 0.18 mg/L

Details on results:

- Behavioural abnormalities: There were no abnormalities in the control medium or the WSF at the end of the test, and all fish were in good condition.
- Mortality of control: No mortalities occurred in the control

Sublethal observations / clinical signs:

Table 1: Results of chemical analysis

Dose	Measured Concentration mg/L
	t = 0 h (clean)	t = 24 h (spent)	t = 48 h (clean)	t = 72 h (spent)
0	<0.04	<0.04	<0.04	<0.04
WSF	0.04	0.05	0.18	0.15
WSF	0.06	0.05	0.13	0.14

 

Table 2: Condition of the fish

Time (h)	Dose
	0	WSF
0	10a	10a
3	10a	10b
24	10a	10b
48	10a	10b
72	10a	10b
96	10a	10b
a = Conditions of all fish, visually assessed, normal (=good) b = Conditions of all fish, visually assessed, equal to that of the control fish

 

Table 3: Summary of results

Parameter	Effect	Dose	Measured concentration
3h LC50	Mortality	WSF	>aqueous solubility
24h LC50	Mortality	WSF	>aqueous solubility
48h LC50	Mortality	WSF	>aqueous solubility
72h LC50	Mortality	WSF	>aqueous solubility
96h LC50	Mortality	WSF	>aqueous solubility
96H LC100	Mortality	WSF	>aqueous solubility
96h NOEC	Mortality	WSF	≥aqueous solubility
96h NOEC	Condition	WSF	≥aqueous solubility

 

Table 4: Temperature measurements in control aquarium

Time (h)	Temperature (°C)
	C	S
0	23
24		23.9
48	23	24
72		24.2
96		24.1
c = clean s = spent

 

Table 5: pH and oxygen (mg/L) measurements

Time (h)	Concentration
	0				WSF
	pH		O2		pH		O2
	C	S	C	S	C	S	C	S
0	8.1		8.7		8.1		8.6
3				7.5
24	7.9	7.9	8.6	8.0	8.2	7.9	8.6	8.2
48	8.2	7.8	8.8	7.8	8.2	7.9	8.7	8.3
72	8.2	7.9	8.7	7.9	8.2	7.9	8.8	8.3
96		7.9		7.9		7.9		8.1
c = clean s = spent

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions of the study, the 96 h LC50 of the test material in zebra fish (Brachydanio rerio), was found to be greater than the water solubility of the test material.

Executive summary:

The acute toxicity of the test material to fish in Brachydanio rerio (zebra fish) was determined in a semi-static test conducted in accordance with OECD 203 and EU Method C.1 and in line with GLP. Due to the insolubility of the test material the study was performed with a water soluble fraction as a limit test. Under the conditions of the study, the 96 h LC50 of the test material was found to be greater than the water solubility of the test material.

Description of key information

LC50 = >0.09 mg/L (geometric mean of the solubility of the test substance.)  LC50 > water solubility (Aqueous solubility of the test material is between 0.05 and 0.18 mg/L), dioctyltin oxide, OECD 203 and EU Method C.1, Hooftman & de Wolf 2004

Additional information

The acute toxicity of the test material to fish was determined in a semi-static test conducted in accordance with OECD 203 and EU Method C.1 and in line with GLP in Brachydanio rerio (zebra fish). Due to the insolubility of the test material the study was performed with a water soluble fraction as a limit test. Under the conditions of the study, the 96 h LC50 of the test material was found to be greater than the water solubility of the test material (between 0.05 and 0.18 mg/L under the conditions of this study).

 

As the study was performed on a read-across substance in the same category as the registered substance (di-n-octyltin oxide), it was assigned a reliability score of 2 (reliable with acceptable restrictions) in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.