Fatty acids, C9-13-neo-

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:

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

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to O.E.C.D. testing guideline in compliance with the GLPs.

Justification for type of information:

See read across justification.

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes

Analytical monitoring:

yes

Details on test solutions:

An amount of 100 mg/L of Neononanoic acid was added to test medium and stirred for 48 hours under ambient conditions in a sealed aspirator; after standing for 1.5 hours the stock solution Water Accomodated Fraction (WAF method) as drawn off.

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

None

Hardness:

171 mg CaCO3/L

Test temperature:

22.4 - 23.6°C

pH:

5.5 - 8.4

Dissolved oxygen:

8.0 - 8.7 mg/l

Salinity:

freshwater

Nominal and measured concentrations:

The nominal concentrations of the Water Accomodated Fraction were: : 46, 100, 220, 460 and 1000 mg/L.

Details on test conditions:

Treatment was conducted in 100 ml crystallising dishes, completely filled with 100 ml of WAF of neononanoic acid. The higher loading rates had o be adjusted to pH with NaOH. There were 10 Daphnids per replicate with 2 replicates/treatment plus mediun controls. The Daphnids were observed for immobility at: 24 and 48 h.

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

220 mg/L

Nominal / measured:

nominal

Conc. based on:

other: loading rate

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 220 - < 460 mg/L

Nominal / measured:

nominal

Conc. based on:

other: loading rate

Basis for effect:

mobility

Validity criteria fulfilled:

yes

Conclusions:

Based on the conditions of the study, the EC50 for Daphnia was determined to be >220 mg/L and <460 mg/L. The 48 hr NOEC was 220 mg/L.

Executive summary:

The findings of an GLP, O.E.C.D. 202 Testing Guideline study with Daphnia magna conducted under static conditons of exposure demonstrated that the 48 - hr EC50 value was >220 mg/L and <460 mg/L with an the NOEC was 220 mg/L.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to O.E.C.D. testing guideline in compliance with the GLPs.

Justification for type of information:

See read across justification

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

water accommodated fraction: loading rated of 4.6 - 220 mg/L. Stirred for 71 hours

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Post exposure observation period:

None

Hardness:

190 mg CaCO3/L

Test temperature:

18.0 - 19.5°C

pH:

7.2 - 8.6

Dissolved oxygen:

9.1 - 9.4 mg/l

Salinity:

freshwater

Nominal and measured concentrations:

The nominal concentrations of the Water Accomodated Fraction were: : 4.6, 10, 22, 46, 100 and 220 mg/L.

Details on test conditions:

Treatment was conducted in 150 ml Erlenmeyer flasks, completely filled with WAF of VERSATIC 1019. The Daphnids were observed for immobility at: 24 and 48 h.

Duration:

24 h

Dose descriptor:

EL50

Effect conc.:

> 22 - < 46 mg/L

Nominal / measured:

nominal

Conc. based on:

other: loading rate

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 22 - < 46 mg/L

Nominal / measured:

nominal

Conc. based on:

other: loading rate

Basis for effect:

mobility

Validity criteria fulfilled:

yes

Conclusions:

Based on the conditions of the study, the EC50 for Daphnia was determined to be >22 mg/L and <46 mg/L.

Executive summary:

The acute toxicity to D. magna of water accommodated fractions of VERSATIC 1019 was determined in a 48 h static toxicity test . The test was conducted in sealed test vessels. The findings of an GLP, O.E.C.D. 202 Testing Guideline study with Daphnia magna conducted under static conditons of exposure demonstrated that the 48 - hr EC50 value was >22 mg/L and <46 mg/L.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

supporting study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well-documented study report which meets basic scientific principles.

Justification for type of information:

See read across justification

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: US EPA, 1976 EPA-600/9-76-010 Bioassay procedures for the oean disposal permit program

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

no

Test organisms (species):

other: Acartia tonsa

Details on test organisms:

Collected by plankton net from Big Lagoon, an estuary adjacent to testing facility

Test type:

static

Water media type:

saltwater

Total exposure duration:

9 648 h

Test temperature:

20 +- 1oC

pH:

Ranged from 7.1 - 8.0

Dissolved oxygen:

>82% saturation

Salinity:

20 %

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

>= 100 other: ppm

Basis for effect:

mortality

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

65 other: ppm

Basis for effect:

mortality

Remarks on result:

other: 22-192

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

43 other: ppm

Basis for effect:

mortality

Remarks on result:

other: 12-157

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

33.7 other: ppm

Basis for effect:

mortality

Remarks on result:

other: 28.1-40.8 This level was recalculated by EM staff after receipt of study details. (Report orginally states a 96h LC50 of 25 ppm (8.5-75 CL at 95%)

Conclusions:

For short-term toxicity to aquatic invertebrates, Neodecanoic acid did produce an LC50 of 33.7ppm at 96 hours.

Executive summary:

The acute toxicity of Neodecanoic acid measured by mortality to the calanoid copepod (Acartia tonsa) was evaluated in saltwater. Neodecanoic acid produced an acute 96-hour LC50of 33.7 ppm.

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

supporting study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well-documented study report which meets basic scientific principles.

Justification for type of information:

See read across justification

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: US EPA, 1975 EPA-660/3-75-009 Method for acute tox. tests with fish, macroinverts and amphibians

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: test material dissolved in Triethylene glycol
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Triethylene glycol

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Hardness:

180 mg CaCO3/L

Test temperature:

22 +- 1oC

pH:

Ranged from 7.1 - 8.2

Dissolved oxygen:

Ranged from 8.6 - 8.8 mg/L

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

94.2 mg/L

Basis for effect:

mortality

Remarks on result:

other: 77.9-120

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

47.1 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality

Remarks on result:

other: 33.6-57.8

Conclusions:

For short-term toxicity to aquatic invertebrates, Neodecanoic acid did produce 24 hour LC50 of 94.2 mg/L and a 48 hour LC50 of 47.1 mg/L

Executive summary:

The acute toxicity of Neodecanoic acid as measured by mortality to the water flea (Daphnia magna) was evaluated in freshwater. Neodecanoic acid produced a 48 hour LC50 of 47.1 mg/L under the conditions of this study.

Reference 5

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

supporting study

Study period:

1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well-documented study report which meets basic scientific principles.

Justification for type of information:

See read across justification

Reason / purpose for cross-reference:

read-across source

Qualifier:

no guideline available

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: test material dissolved in Triethylene glycol
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Triethylene glycol

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Hardness:

180 mg CaCO3/L

Test temperature:

22 +- 1oC

pH:

Ranged from 7.1 - 8.2

Dissolved oxygen:

Ranged from 8.6 - 8.8 mg/L

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 1 000 mg/L

Basis for effect:

other: immobilization

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

410 mg/L

Basis for effect:

other: immobilization

Remarks on result:

other: 95% fiducial limits, 340 - 490 mg/L

Conclusions:

For short-term toxicity to aquatic invertebrates, the test material produced a 24 hour EC50 of greater than 1000 mg/L and a 48 hour EC50 of 410 mg/L

Executive summary:

The acute toxicity of test material as measured by immobilization to the water flea (Daphnia magna) was evaluated in freshwater. The test material produced a 48 hour EC50 of 410 mg/L under the conditions of this study.

Reference 6

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

supporting study

Reliability:

1 (reliable without restriction)

Justification for type of information:

See read across justification

Reason / purpose for cross-reference:

read-across source

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Samples were taken at the start and end of the 48 h test period.

Vehicle:

no

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

175 mg CaCO3/L

Test temperature:

20.3-21.4

pH:

7.7-8.5

Dissolved oxygen:

9-9.4

Nominal and measured concentrations:

Nominal: 46, 100, 220, 460, 1000 mg/L
Measured: 42, 88, 202, 409, 457 mg/L

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EL50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Validity criteria fulfilled:

yes

Conclusions:

The 48-h EL50 for D. magna was >1000 mg/L.

Executive summary:

The 48-h EL50 for D. magna was >1000 mg/L.

Description of key information

Data from neononanoic acid is read across to the C9-13 neofatty acids.  The acute Daphnia magna O.E.C.D. Testing Guideline 202, Klimisch 1, GLP compliant study conducted in 1998 is the most appropriate and reliable study for estimating the freshwater crustacea PNEC.  The NOEC for this study was 220 mg/L.  The study used the Water Accomodated Fraction of the test substance.

Additional information

Data from neononanoic acid is read across to the C9 -13 neofatty acids. ECHA guidance (RIP 3.2, Chapter R.10) suggests applying an Assessment Factor of 1000-fold to the NOEC for estimating a freshwater PNEC from acute aquatic data. Therefore, the estimated PNEC for freshwater crustacea based on the Daphnia magna study data is220 (mg/L)/1000 = 0.22 mg/L. Estimation of a marine crustacea PNEC from acute study data requires an Assessment Factor of 10,000 as proposed by ECHA. Therefore, the marine crustacea PNEC based on the Daphnia magna study data is 220 (mg/L)/10,000 = 0.022 mg/L.

In an OECD 202 on neodecanoic acid the 48 hr EL50 for D. magna was >1000 mg/L.

For short-term toxicity to aquatic invertebrates, the neodecanoic acid produced a 24 hour EC50 of greater than 1000 mg/L and a 48 hour EC50 of 410 mg/L

In an OECD 202 on C-10 -20, fatty accid -neo the EC50 for Daphnia was determined to be >22 mg/L and