Reaction products of furan-2,5-dione and octadec-1-ene

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

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 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, 2009

Analytical monitoring:

yes

Details on sampling:

- Sampling method: Samples for concentration control analysis were taken from each freshly prepared solution (0 h and 24 h) from additionally prepared test vessels without daphnids and at the end of each exposure interval (after approx. 24 h and 48 h) from all test vessels with mobile daphnids and the lowest concentration with 100% immobilisation.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Water accommodated fraction (WAF) of the test substance were prepared according to OECD 23. Fresh test solutions were prepared at 0 and 24 hours. The test substance was homogenized by shaking the container before removal for weighing. The stock solutions were prepared by weighing the test substance on a glass coverslip then adding this to 1L of test medium in a 2 L glass flask. The stock solutions were shaken for approximately 10 min at 20 ± 2 °C.
- Differential loading: yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The test groups 22 - 100 mg/L appeared turbid after preparation. Since the test substance was homogenously dispersed in the test medium, no attempt was made to separate any potentially undissolved components. The daphnids were exposed to the entire loaded mass of test substance.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Source: Daphnia magna STRAUS was originally supplied from "Institut National de Recherche Chimique Appliquée, France", and has been breeded from 1978 in the Laboratories of BASF.
- Age at study initiation (mean and range, SD): <24 hours old
- Food type: Unicellular algae Desmodesmus subspicatus, cultured continuously at the test facility
- Frequency: Daily
- Photoperiod: 16 hours light, 8 hours dark
- Culture media: synthetic fresh water (Elendt M4) prepared according to OECD 202
- Renewal of the culture water: Twice weekly

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

2.2 - 3.2 mmol/L (total hardness)

Test temperature:

19.5 - 20.0 °C

pH:

7.5 - 8.5

Dissolved oxygen:

> 3 mg/L (8.4 - 9.2 mg/L)

Nominal and measured concentrations:

Nominal (loading rate): 4.6, 10, 22, 46 and 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers (nominal volume 100 mL), test volume 50 mL. All test vessels were saturated for at least 24-h before use with solution to reduce the possibility of test substance loss during the test by adsorption to the test vessel. This solution was discarded and fresh test solution was used to start the test.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline: M4 medium with the properties:
Total hardness: 2.20 - 3.20 mmol/L
Alkalinity up to pH 4.3: 0.8 - 1.0 mmol/L
Ratio Ca/Mg ions: about 4:1
pH value: 7.5 - 8.5
Conductivity: 550 - 650 microS/cm

OTHER TEST CONDITIONS
- Photoperiod: 16:8 hours, diffuse light (about 172 - 654 lux at a wave length of 400-750 nm)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Observations: mobile daphnids after 24 and 48 h
Measurements: Temperature, pH and oxygen content after 0, 24 and 48 h

TEST CONCENTRATIONS
Nominal test concentrations: 4.6, 10, 22, 46 and 100 mg/l. A control was tested in parallel.

Reference substance (positive control):

yes

Remarks:

potassium dichromate (K2Cr2O7)

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

36.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 27.4 - 49.6 mg/L

Key result

Duration:

48 h

Dose descriptor:

EL0

Effect conc.:

4.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EL0

Effect conc.:

22 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Mortality of control: no
- Effects: After 24 h effects could be observe at 46 mg/L (one daphnid was immobilized) and 100 mg/L (two daphnids were immobilized). After 48 h one daphnid was immobilized at 10 mg/L and 8 daphnids at 22 mg/L. The maximum amount of daphnids (18 daphnids) were immobilized at 100 mg/L.
- Effect concentrations exceeding solubility of substance in test medium: The test groups 22 - 100 mg/L appeared turbid after preparation. The daphnids at concentrations 46 and 100 mg/L were covered with test substance at the end of exposure (48h).

Results with reference substance (positive control):

Tests with a reference substance, potassium dichromate (K2Cr2O7), are conducted monthly. Reference substance tests are conducted according to OECD 202 guidelines and in accordance with GLP, but without a GLP status.
The EC50(24h) of the reference substance potassium dichromate was 1.10 mg/L. Date of the last control experiment: 15 Mar 2010, project number: 50E0063/043039.

Validity criteria fulfilled:

yes

Remarks:

≤ 10% mortality in the control and O2 concentration > 3 mg/L in the control and test vessels

Conclusions:

The 48 hour EC50 values for ASA in this acute toxicity study with Daphnia magna was 36.3 mg/L based on the loading rate of the test substance.

Executive summary:

In a test performed according to OECD 202, Daphnia magna were exposed to the nominal loading rates of 4.6, 10, 22, 46 and 100 mg/L test substance in 4 replicates of each 5 animals. Although at high concentrations the water solubility seemed to be exceeded, the EC50(48 h) was estimated to be 36.6 mg/L based on observed immobilization at lower concentrations.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

This study was conducted on 2,5-furandione, dihydro-, mono-C15- 20-alkenyl derivatives (CAS 68784-12-3), an analogue substance used as the source of information for the assessment of the target substance through read-across. Therefore, this study is informative for evaluation of the environmental fate and toxicity of the target substance, Reaction products of furan-2,5-dione and octadec-1-ene (known here as n-ODSA EC 701-338-8; no CASRN available), and it is adequate for classification and risk assessment.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, 2009

Specific details on test material used for the study:

As a result of increasingly rigorous criteria being applied to the analysis of commercial material used in physical property/toxicity testing, the identity of the material has been modified to reveal a more accurate and precise depiction of the commercial substance. This enhancement is reflected in changes in chemical identifiers such as EC and/or CAS numbers from those noted in earlier versions of data records or in study reports.

Analytical monitoring:

yes

Details on sampling:

- Sampling method: Samples for concentration control analysis were taken from each freshly prepared solution (0 h and 24 h) from additionally prepared test vessels without daphnids and at the end of each exposure interval (after approx. 24 h and 48 h) from all test vessels with mobile daphnids and the lowest concentration with 100% immobilisation.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Water accommodated fraction (WAF) of the test substance were prepared according to OECD 23. Fresh test solutions were prepared at 0 and 24 hours. The test substance was homogenized by shaking the container before removal for weighing. The stock solutions were prepared by weighing the test substance on a glass coverslip then adding this to 1L of test medium in a 2 L glass flask. The stock solutions were shaken for approximately 10 min at 20 ± 2 °C.
- Differential loading: yes
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The test groups 22 - 100 mg/L appeared turbid after preparation. Since the test substance was homogenously dispersed in the test medium, no attempt was made to separate any potentially undissolved components. The daphnids were exposed to the entire loaded mass of test substance.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna STRAUS
- Source: Daphnia magna STRAUS was originally supplied from "Institut National de Recherche Chimique Appliquée, France", and has been breeded from 1978 in the Laboratories of BASF.
- Age at study initiation (mean and range, SD): <24 hours old
- Food type: Unicellular algae Desmodesmus subspicatus, cultured continuously at the test facility
- Frequency: Daily
- Photoperiod: 16 hours light, 8 hours dark
- Culture media: synthetic fresh water (Elendt M4) prepared according to OECD 202
- Renewal of the culture water: Twice weekly

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

2.2 - 3.2 mmol/L (total hardness)

Test temperature:

19.5 - 20.0 °C

pH:

7.5 - 8.5

Dissolved oxygen:

> 3 mg/L (8.4 - 9.2 mg/L)

Nominal and measured concentrations:

Nominal (loading rate): 4.6, 10, 22, 46 and 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers (nominal volume 100 mL), test volume 50 mL. All test vessels were saturated for at least 24-h before use with solution to reduce the possibility of test substance loss during the test by adsorption to the test vessel. This solution was discarded and fresh test solution was used to start the test.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline: M4 medium with the properties:
Total hardness: 2.20 - 3.20 mmol/L
Alkalinity up to pH 4.3: 0.8 - 1.0 mmol/L
Ratio Ca/Mg ions: about 4:1
pH value: 7.5 - 8.5
Conductivity: 550 - 650 microS/cm

OTHER TEST CONDITIONS
- Photoperiod: 16:8 hours, diffuse light (about 172 - 654 lux at a wave length of 400-750 nm)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Observations: mobile daphnids after 24 and 48 h
Measurements: Temperature, pH and oxygen content after 0, 24 and 48 h

TEST CONCENTRATIONS
Nominal test concentrations: 4.6, 10, 22, 46 and 100 mg/l. A control was tested in parallel.

Reference substance (positive control):

yes

Remarks:

potassium dichromate (K2Cr2O7)

Key result

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

36.3 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 27.4 - 49.6 mg/L

Key result

Duration:

48 h

Dose descriptor:

EL0

Effect conc.:

4.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EL0

Effect conc.:

22 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Mortality of control: no
- Effects: After 24 h effects could be observe at 46 mg/L (one daphnid was immobilized) and 100 mg/L (two daphnids were immobilized). After 48 h one daphnid was immobilized at 10 mg/L and 8 daphnids at 22 mg/L. The maximum amount of daphnids (18 daphnids) were immobilized at 100 mg/L.
- Effect concentrations exceeding solubility of substance in test medium: The test groups 22 - 100 mg/L appeared turbid after preparation. The daphnids at concentrations 46 and 100 mg/L were covered with test substance at the end of exposure (48h).

Results with reference substance (positive control):

Tests with a reference substance, potassium dichromate (K2Cr2O7), are conducted monthly. Reference substance tests are conducted according to OECD 202 guidelines and in accordance with GLP, but without a GLP status.
The EC50(24h) of the reference substance potassium dichromate was 1.10 mg/L. Date of the last control experiment: 15 Mar 2010, project number: 50E0063/043039.

Validity criteria fulfilled:

yes

Remarks:

≤ 10% mortality in the control and O2 concentration > 3 mg/L in the control and test vessels

Conclusions:

The 48 hour EC50 values for ASA in this acute toxicity study with Daphnia magna was 36.3 mg/L based on the loading rate of the test substance.

Executive summary:

In a test performed according to OECD 202, Daphnia magna were exposed to the nominal loading rates of 4.6, 10, 22, 46 and 100 mg/L test substance in 4 replicates of each 5 animals. Although at high concentrations the water solubility seemed to be exceeded, the EC50(48 h) was estimated to be 36.6 mg/L based on observed immobilization at lower concentrations.

Description of key information

The key study was a semi-static acute daphnid toxicity test on the freshwater invertebrate, Daphnia magna, by read-across from an analogue substance.  

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

36.3 mg/L

Additional information

The substance was shown to exhibit toxicity to the freshwater invertebrate Daphnia magna, by read-across based on a chemical category. The 48-h EL₀ and EL₅₀ values reported from the semi-static and static tests were 4.6 mg/L and 36.3 mg/L, respectively, based on loading rates.

This information is from the substance 2,5-furandione, dihydro-,mono-C15-20-alkenylderivatives (CAS 68784-12-3, a mixture of a hexadecenyl- and octadecenyl succinic anhydrides, and also known as Pentasize^TM68, AS 1100^TMand AS 1000^TM), an analogue used for the assessment of several endpoints through read-across. The hypothesis for read-across between the substance being registered (Reaction products of furan-2,5-dione and octadec-1-ene; known here as n-ODSA EC 701-338-8; no CASRN available), and the analogue substance is a common functional group: a 2,5-furandione, dihydro- structure, also known as a succinic anhydride, to which is attached a long-chain monounsaturated olefin. In the environment, the anhydride moiety is quickly hydrolysed to form a dioic acid.  When the substance to be registered and the analogue substance are compared, changes in the purity of the starting olefin stock, or small differences in the length (between sixteen and twenty) or arrangement (linear or branched) of the carbon chain are not anticipated to significantly affect the environmental fate properties or the toxicity of the substances. For each endpoint study based upon read-across, the analogue approach is substantiated by an evaluation provided in the Analogue Approach Report Format (AARF) attached to the endpoint study summary file. The AARF allows the read-across information to fulfil the information requirements of the REACH Annexes VII-X, to be the basis for classification and labelling decisions, and for risk assessment.