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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19-08-1996 to 23-08-1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP study, method is clear and all criteria are met so the study is valid, by read-across based on a chemical category. However data is missing on the stability of the test substance and since no analysis has been performed the actual exposure remains uncertain.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP Monitoring Authority, Dep. Health UK, 1996

Analytical monitoring:

no

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: For the purpose of the definitive study the test material was prepared using a preliminary solution in dimethylsulphoxide.
An amount of test material (200 mg) was dissolved in 2.0 mL of solvent prior to dispersal in approximately 15 mL of reverse osmosis water with the aid of ultrasonic disruption for about 30 minutes. This mixture was then dispersed in approximately 4 litres of dechlorinated tap water with the aid of ultrasonic disruption for about 1 hour prior to adjusting the volume to 20 litres to give a 10 mg/L test concentration. The test vessels were furnished with shielded propeller stirrers in order to maintain a homogenous dispersion of the test material.

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: Golden orfe
- Strain: Leuciscus idus
- Source: Xotic Fish Centre, Alfreton, Derbyshire, UK
- Length at study initiation (length definition, mean, range and SD): Mean standard length of 5.4 cm (s.d. = 0.2)
- Weight at study initiation (mean and range, SD): Mean weight of 1.66 g (s.d. = 0.17) at the end of the definitive study


ACCLIMATION
- Acclimation period: From 12 August 1996 to 19 August 1996. The lighting cycle was controlled to give a 16 hours light and
8 hours darkness cycle.
- Acclimation conditions (same as test or not): Yes
- Type and amount of food: commercial Tetramin® flake food
- Feeding frequency: Daily, but discontinued 48 hours prior to the start of the definitive study
- Health during acclimation (any mortality observed): No mortality

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

100 mg/L CaCO3

Test temperature:

21 °C

pH:

7.6-8.0

Dissolved oxygen:

8.0-8.5 mg/L

Nominal and measured concentrations:

nominal: 10 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 20 litre glass exposure vessels
- Type: closed
- Aeration: shielded propeller stirrers
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.83 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water dechlorinated by passage through an activated carbon filter

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Any mortalities and sub-lethal effects of exposure were recorded at 3, 6, 24, 48, 72 and 96 hours after the start of exposure. The criteria of death were taken to be the absence of both respiratory movement and response to physical stimulation.

TEST CONCENTRATIONS
- Range finding study: In the range-finding study 3 fish were exposed to a series of nominal test concentrations of 1.0 and 10 mg/L.
- Results used to determine the conditions for the definitive study: The results showed no mortalities at the test concentrations of 1.0 and 1 O mg/L. However, during the preliminary solubility work performed precipitation of the test material was observed at concentrations in excess of 10 mg/L indicating this to be the maximum limit of water solubility of the test material under these test conditions.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

There were no mortalities in 20 fish exposed to a test concentration of 10 mg/L for a period of 96 hours.

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of Pentasize 68 to the freshwater fish golden orfe (Leuciscus idus) has been investigated and gave a 96-Hour LC50 of greater than 10 mg/L nominal. Correspondingly the No Observed Effect Concentration was greater than or equal to 10 mg/L nominal. All criteria are met so the study is valid. However data is missing on the stability of the testsubstance and since no analysis has been performed the actual exposure remains uncertain.

Executive summary:

A study was performed to assess the acute toxicity of the test material, Pentasize 68, to golden orfe (Leuciscus idus) in accordance with OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC) and the Guidelines of the German Water Hazard Classification Scheme (Bewertung Wassergefahrdender Stoffe LTWS - Nr 10). Following a preliminary range-finding study two groups of ten fish were exposed to an aqueous dispersion of the test material at a concentration of 10 mg/L for a period of 96 hours under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the study until termination after 96 hours. As a result, the 96-Hour LC50 based on nominal test concentrations was greater than 10 mg/L and correspondingly the No Observed Effect Concentration was greater than or equal to 10 mg/L. The test concentration of 10 mg/L was the highest attainable test concentration due to the limited solubility of the test material in water and auxiliary solvent, and having due regard for the amount of auxiliary solvent permitted in the test under the OECD Guidelines.

Given that the LC50 can only be estimated as greater than 10 mg/I (> 10 ppm = 1 x 10-s) the evaluation number (Bewertungszahl, BWZ) for the German Water Hazard Classification Scheme can only be estimated as being less than 5.

 

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

19-08-1996 to 23-08-1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

GLP study, method is clear and all criteria are met so the study is valid, by read-across based on a chemical category. However data is missing on the stability of the test substance and since no analysis has been performed the actual exposure remains uncertain.

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 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP Monitoring Authority, Dep. Health UK, 1996

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:

no

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: For the purpose of the definitive study the test material was prepared using a preliminary solution in dimethylsulphoxide.
An amount of test material (200 mg) was dissolved in 2.0 mL of solvent prior to dispersal in approximately 15 mL of reverse osmosis water with the aid of ultrasonic disruption for about 30 minutes. This mixture was then dispersed in approximately 4 litres of dechlorinated tap water with the aid of ultrasonic disruption for about 1 hour prior to adjusting the volume to 20 litres to give a 10 mg/L test concentration. The test vessels were furnished with shielded propeller stirrers in order to maintain a homogenous dispersion of the test material.

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: Golden orfe
- Strain: Leuciscus idus
- Source: Xotic Fish Centre, Alfreton, Derbyshire, UK
- Length at study initiation (length definition, mean, range and SD): Mean standard length of 5.4 cm (s.d. = 0.2)
- Weight at study initiation (mean and range, SD): Mean weight of 1.66 g (s.d. = 0.17) at the end of the definitive study


ACCLIMATION
- Acclimation period: From 12 August 1996 to 19 August 1996. The lighting cycle was controlled to give a 16 hours light and
8 hours darkness cycle.
- Acclimation conditions (same as test or not): Yes
- Type and amount of food: commercial Tetramin® flake food
- Feeding frequency: Daily, but discontinued 48 hours prior to the start of the definitive study
- Health during acclimation (any mortality observed): No mortality

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

100 mg/L CaCO3

Test temperature:

21 °C

pH:

7.6-8.0

Dissolved oxygen:

8.0-8.5 mg/L

Nominal and measured concentrations:

nominal: 10 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 20 litre glass exposure vessels
- Type: closed
- Aeration: shielded propeller stirrers
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.83 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water dechlorinated by passage through an activated carbon filter

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light and 8 hours darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Any mortalities and sub-lethal effects of exposure were recorded at 3, 6, 24, 48, 72 and 96 hours after the start of exposure. The criteria of death were taken to be the absence of both respiratory movement and response to physical stimulation.

TEST CONCENTRATIONS
- Range finding study: In the range-finding study 3 fish were exposed to a series of nominal test concentrations of 1.0 and 10 mg/L.
- Results used to determine the conditions for the definitive study: The results showed no mortalities at the test concentrations of 1.0 and 1 O mg/L. However, during the preliminary solubility work performed precipitation of the test material was observed at concentrations in excess of 10 mg/L indicating this to be the maximum limit of water solubility of the test material under these test conditions.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

There were no mortalities in 20 fish exposed to a test concentration of 10 mg/L for a period of 96 hours.

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of Pentasize 68 to the freshwater fish golden orfe (Leuciscus idus) has been investigated and gave a 96-Hour LC50 of greater than 10 mg/L nominal. Correspondingly the No Observed Effect Concentration was greater than or equal to 10 mg/L nominal. All criteria are met so the study is valid. However data is missing on the stability of the testsubstance and since no analysis has been performed the actual exposure remains uncertain.

Executive summary:

A study was performed to assess the acute toxicity of the test material, Pentasize 68, to golden orfe (Leuciscus idus) in accordance with OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC) and the Guidelines of the German Water Hazard Classification Scheme (Bewertung Wassergefahrdender Stoffe LTWS - Nr 10). Following a preliminary range-finding study two groups of ten fish were exposed to an aqueous dispersion of the test material at a concentration of 10 mg/L for a period of 96 hours under semi-static test conditions. The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 3 and 6 hours after the start of exposure and then daily throughout the study until termination after 96 hours. As a result, the 96-Hour LC50 based on nominal test concentrations was greater than 10 mg/L and correspondingly the No Observed Effect Concentration was greater than or equal to 10 mg/L. The test concentration of 10 mg/L was the highest attainable test concentration due to the limited solubility of the test material in water and auxiliary solvent, and having due regard for the amount of auxiliary solvent permitted in the test under the OECD Guidelines.

Given that the LC50 can only be estimated as greater than 10 mg/I (> 10 ppm = 1 x 10-s) the evaluation number (Bewertungszahl, BWZ) for the German Water Hazard Classification Scheme can only be estimated as being less than 5.

 

Description of key information

The key study was a semi-static acute fish toxicity limit test on freshwater fish, the golden orfe (Leuciscus idus), by read-across from an analogue substance. 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

10 mg/L

Additional information

The read-across substance was not shown to exhibit toxicity to the freshwater fish, the golden orfe (Leuciscus idus). The 96-h NOEC was reported as 10 mg/L, and the 96-h LC50 was reported as > 10 mg/L. 

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.