L-Glutamic acid, N-coco acyl derivs., disodium salts

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:

1990-01-22 to 1990-03-05

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study with acceptable restrictions (no analytical verification of test concentration, oxygen depletion to 4.4 mg/L in the highest test concentration of 200 mg/L)

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substances was directly added to the test vessels.

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: orfe
- Source: Fish farm Eggers, Hohenwestedt
- Age at study initiation: approx. 4 weeks
- Corpulence factor: 0.8 - 1.1 g/cm^3
- Feeding during test: none

ACCLIMATION
- Acclimation period: For at least 7 days
- Acclimation conditions: same dilution water
- Type and amount of food: Pitti Floxi-Flocken Alleinfutter für Zierfische
- Feeding frequency: twice a week

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

15 ± 3° dH (total hardness)

Test temperature:

20 ± 0.5 °C

pH:

7.3 - 8.2

Dissolved oxygen:

4.4 - 8.6 mg/L

Nominal and measured concentrations:

Nominal concentration: 150, 175, 190 and 200 mg/L (based on test material)
Nominal concentration: 48, 56, 60.8 and 64 mg/L (based on active matter)

Details on test conditions:

TEST SYSTEM
- Test vessel: tanks (L 28.5 cm / W 21.0 cm / H 24.0 cm)
- Material: glass; Fill volume: 15 L
- Aeration: weak aeration during test period
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 3.7 fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: mixture of drinking water and deionized water
- Ca/mg ratio: 4:1
- Culture medium different from test medium: no
- Intervals of water quality measurement: Oxygen concentration and pH were measured after 24, 48, 72 and 96 h test duration.

EFFECT PARAMETERS MEASURED: Mortality was recorded after 24, 48, 72 and 96 h test duration.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: approx. 1.1

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

62.4 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: converted to active matter

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

195 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

190 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

200 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: none

Validity criteria fulfilled:

yes

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

Reason / purpose for cross-reference:

read-across source

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

62.4 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Description of key information

In a final decision on a compliance check ECHA requested the registrant to conduct a long-term toxicity testing on fish with CAS 68187-30-4. According to the decision, to Annex VIII, Section 9.1.3, Column 2 of REACH and to prevent unnecessary animal testing, a short-term toxicity study on fish does not need to be provided.

A corresponding waiver will be included in the dossier when the results of the long-term toxicity study on fish are available and the current study with the source substance l-Glutamic acid, N-coco acyl derivs., monosodium salts (CAS No. 68187-32-6) will be marked as disregarded due to methodological deficiencies.

 

 

Additional information

No studies investigating the short-term toxicity of l-Glutamic acid, N-coco acyl derivs., disodium salts (CAS No. 68187-30-4) to freshwater fish are available. Thus, available data for the source substance l-Glutamic acid, N-coco acyl derivs., monosodium salts (CAS No. 68187-32-6) was used in a read across approach. The read across is considered valid as both substances are structurally identical (solely differing in the degree of deprotonation being di- and monosodium salts, respectively), which assume very similar physico-chemical properties resulting in identical environmental behavior and ecotoxicity.

The read across key study was performed according to GLP and OECD guideline 203 using Leuciscus idus as test organism (Hoechst, 1990). A 32 % solution of the UVCB substance in water was tested. Nominal concentrations between 48 and 64 mg/L (based on active matter) were tested over a period of 96 h. The 96h-LC50 is determined to be 62.4 mg/L. Due to the very high structural similarity, this result can also be considered for l-Glutamic acid, N-coco acyl derivs., disodium salts (CAS No. 68187-30-4).

 

In a final decision on a compliance check ECHA requested the registrant to conduct a long-term toxicity testing on fish with CAS 68187-30-4. According to the decision, to Annex VIII, Section 9.1.3, Column 2 of REACH and to prevent unnecessary animal testing, a short-term toxicity study on fish does not need to be provided. A corresponding waiver will be included in the dossier when the results of the long-term toxicity on fish study are available and the current study with the source substance l-Glutamic acid, N-coco acyl derivs., monosodium salts (CAS No. 68187-32-6) will be marked as disregarded due to methodological deficiencies.