Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to analogue justification provided in IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: Water Accommodated Fraction (WAF)
Basis for effect:
mobility
Remarks on result:
other:
Remarks:
Source: Key, source, RA-A, CAS 95912-87-1, BASF, 2001, D. magna, 48 h, RL1
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: Water Accommodated Fraction (WAF) + Emulsifier
Basis for effect:
mobility
Remarks on result:
other:
Remarks:
Source: Key, source, RA-A, CAS 95912-87-1, BASF, 2001, D. magna, 48 h, RL1
Conclusions:
The retained effect concentration for the short-term toxicity to aquatic invertebrates is an EL50 (48 h) of > 100.0 mg/L (nominal, EU Method C.2./OECD 202, read-across).
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:
yes
Remarks:
Only two replicates were used instead of four as recommended.
Qualifier:
according to guideline
Guideline:
ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
Deviations:
yes
Remarks:
The pH of the dilution water was slightly higher (8.0 +/- 0.2).
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test solutions were prepared separately and mixed with test medium for a defined period. Subsequently, the test solutions were allowed to stabilize in a separating funnel. The water phase in the middle of the separating funnel was used for testing and was identified as the Water Accommodated Fraction (WAF).
- Eluate: no
- Differential loading: yes
- Controls: yes, water control
- Evidence of undissolved material: All final test solutions were clear and colourless.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Age at study initiation: < 24 h
- Method of breeding: Daphnia were held at a temperature of 18 – 22 °C. A new batch was started with newborn animals, i.e. less than 3 d old, by placing about 250 of them into 30 L of medium in an all-glass culture vessel. The maximum age of culture was 4 weeks. After 7 d of cultivation half of the medium was renewed. Daphnids were fed daily with a suspension of fresh water algae.
- Feeding during test: no
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Test temperature:
21.3 °C
pH:
7.8 - 7.9
Dissolved oxygen:
8.1 - 8.6 mg O2/L
Nominal and measured concentrations:
Nominal: 0, 86 mg/L (corresponding to 100 µL/L)
Details on test conditions:
TEST SYSTEM
- Test vessel: all-glass vessels
- Material, size, fill volume, headspace: all-glass, 100 mL, Fill volume: 80 mL, Headspace: 20 mL
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Medium was prepared according to ISO guideline in milli-RO water
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark

EFFECT PARAMETERS MEASURED: Immobility was recorded after 24 and 48 h.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: control, WAFs at 10 and 100 mg/L (range finding study 1); control, WAFs at 0.86 and 8.6 mg/L (range finding study 2)
- Results used to determine the conditions for the definitive study: At WAFs prepared at 10 and 100 mg/L daphnids trapped at the surface of test solutions. At WAFs prepared at 0.86 and 8.6 mg/L the stabilisation period was increased to 24 h to overcome daphnids becoming trapped at the surface. No effects were observed in the second range-finding study.
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 86 mg/L
Nominal / measured:
nominal
Conc. based on:
other: Water Accommodated Fraction (WAF)
Basis for effect:
mobility
Details on results:
- Mortality of control: no
- Effect concentrations exceeding solubility of substance in test medium: The test solutions at 86 mg/L (nominal) exceeded the maximum water solubility of the test substance.
Results with reference substance (positive control):
- Results with reference substance valid? yes
- EC50/LC50: 48 h EC50 was 0.5 mg/L (95% Confidence Limit: 0.4 - 0.6 mg/L)
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 Jan - 01 Feb 2001
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: WAF of 100 mg test substance/L; WAF of 100 mg test substance/L + 10 mg/L TAGAT CH 60 (emulsifier)
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: A stock solution of 100 mg/L in M4-medium was prepared. It was stirred for about 24 h. After a settling time of about 2 h the solution was siphoned by a pipette and filtered via 0.2 µm membrane filter (WAF, filtered). This test solution was split up in two parts. To one of them the emulsifier TAGAT CH 60 was added at a concentration of 10 mg/L.
- Controls: A control with M4-medium and a solvent control with M4-medium and the emulsifier was conducted
- Chemical name of vehicle: TAGAT CH 60
- Concentration of vehicle in test medium: 10 mg/L
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Source: Ephippia were obtained from Creasel, 98000 Deinze, Belgium (Batch: DM / M 270999)
- Method of breeding: Ephippia were hatched in M4-medium at approx. 4800 lux and 20 °C. The incubation of neonates was performed in M4-medium according to Elendt at 20 °C and approx. 900 lux (16 h light and 8 h dark). Neonates were fed with green algae (Scenedesmus subspicatus).
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Test temperature:
20 °C
pH:
8.0 (48 h)
Dissolved oxygen:
98% (48 h)
Nominal and measured concentrations:
Nominal: 0, 100 mg/L
Measured (WAF of 100 mg/L): 0.2 mg/L (0 h), 0.1 mg/L (24 h), < 0.1 mg/L (48 h)
Measured (WAF, filtered + 10 mg/L TAGAT CH 60): 0.1 mg/L (0 h), < 0.1 mg/L (24 h), 0.1 mg/L (48 h)
Details on test conditions:
TEST SYSTEM
- Test vessel: beakers
- Type: covered with glass plates
- Material, size, fill volume, headspace: glass, 100 mL, Fill volume: 50 mL, Headspace: 50 mL
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2 (WAF), 2 (WAF + emulsifier)
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): 2

OTHER TEST CONDITIONS
- Photoperiod: 16 h light / 8 h dark
- Light intensity: approx. 900 lux

EFFECT PARAMETERS MEASURED: immobilization was noted every 24 h
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: Water Accommodated Fraction (WAF)
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: Water Accommodated Fraction (WAF) + Emulsifier
Basis for effect:
mobility
Details on results:
- Mortality of control: 0%
Results with reference substance (positive control):
- EC50 (24 h): 0.98 mg/L which is in the range of 0.9 and 1.9 mg/L proposed for validity of the test.

Table 1: Immobilization of test species after 24 h and 48 h.

sample name

replicate

immobilised test species [%]

24 h

48 h

control

1

0

0

 

2

0

0

Solvent control

1

0

0

 

2

0

0

WAF, filt. (100 mg/L)

1

0

0

 

2

0

0

WAF (100 mg/L) + TAGAT

1

0

0

 

2

0

0

Description of key information

No effects up to the limit of water solubility (< 2.5 µg/L, 20 °C; OECD 202, D. magna); read-across

Key value for chemical safety assessment

Additional information

There is no study available, in which the short-term toxicity of the target substance fatty acids, C14-22, C16-24-alkyl esters (CAS 92797-30-3) to aquatic invertebrates was assessed. Therefore, read-across to the structurally related source substances fatty acids, C16-18, C12-18-alkyl esters (CAS 95912-87-1) and 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was conducted in accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5. The source substances are characterized by fatty acid esters of similar chain lengths and are therefore considered suitable representatives for the assessment of the short-term toxicity of the target substance to aquatic invertebrates. A detailed justification of the analogue approach is provided in IUCLID section 13.

The available study with the source substance fatty acids, C16-18, C12-18-alkyl esters (CAS 95912-87-1) was conducted according to EU Method C. 2 and GLP (BASF, 2001). In a static test, the water fleaDaphnia magnawas exposed to a Water Accommodated Fraction (WAF) with a nominal loading concentration of 100 mg/L for 48 h. The test material concentrations were analytically determined by GC and were 0.1 to 0.2 mg/L or below the limit of detection.

After 48 h, no effects were observed and an EL50 (48 h) of > 100 mg/L (nominal) was derived. Thus, fatty acids, C16-18, C12-18-alkyl esters (CAS 95912-87-1) does not cause toxic effects to aquatic invertebrates up to the limit of water solubility (< 0.05 mg/L).

The available study with the source substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was conducted according to OECD guideline 202 and GLP (Croda, 1998). In a static limit test,D. magnawas exposed to a WAF with a nominal loading concentration of 86 mg/L. An analytical verification of the actual test material concentration in the test vessels was not possible due to the very low water solubility of the test item. After 48 h, no immobilization was observed and an EL50 (48 h) of > 86 mg/L (nominal) was derived. Thus, 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) does not cause toxic effects to aquatic invertebrates up to the limit of water solubility (< 0.05 mg/L).

Based on the structural and chemical similarity of the target and source substances, the target substance is expected to exhibit a similar ecotoxicological profile as the source substances. Therefore, it can be concluded that the target substance fatty acids, C14-22, C16-24-alkyl esters (CAS 92797-30-3) does not cause short-term effects to aquatic invertebrates up to the limit of water solubility (< 2.5 µg/L).