Disodium Capryloyl Glutamate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 19, 2016 to January 25, 2016

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:

Quality Assurance Statement is at page 4 of the report

Specific details on test material used for the study:

Batch no.: 145
Dry matter: 37.6% in water (water to 100%)
Purity: 90.4% on the dry matter
Solubility: soluble in water
Being the report done before ECHA Agreement on substance name, the name on the report is L-Glutamic acid, N-(1-oxooctyl)-,sodium salt (1:2) but the substance tested is the reference substance. All raw materials used and manufacturing process are the same

Analytical monitoring:

yes

Remarks:

Measurement of analytical total organic carbon (TOC) concentrations with a TOC analyser

Details on sampling:

- Samples, properly diluted with deionised water with low TOC contents, have been analysed by means of an integrated sampling system directly from vials containing 40 ml volume. For each sample under test the corresponding blank is analysed.
- Calculations:
% stability: (TOC test subst. 48h - TOC control 48h)/(TOC test subst. 0h - TOC control 0h). Samples are considered stable if the % stability is between 80 and 120% of the value.
- The samplings were stable throughout the test period.
- The percentage of stability was 97% (table 5 of the test attached)

Vehicle:

no

Remarks:

Substance is already in water solution

Details on test solutions:

Range finding test: 0.1-1000 mg/l
Definitive test: 100 mg/l

Test organisms (species):

Daphnia magna

Details on test organisms:

Age: 6 - 24 hours
Origin: Breeder in Eurofins Biolab Test Facility
Feeding: green alga
Number of animals: 20/group
Number of replications: 4/group

Test type:

static

Water media type:

other: deionized water + dissolved salts (CaCl2.H2O, MgSO4.7H2O, KCl, NaHCO3)

Limit test:

yes

Total exposure duration:

48 h

Hardness:

250 mg CaCO3/l

Test temperature:

20 °C +- 0.1 °C

pH:

7.44-7.85

Dissolved oxygen:

5.79-6.99 mg/l

Nominal and measured concentrations:

Range finding test: 0.1-1000 mg/l
Definitive test: 100 mg/l

Details on test conditions:

Photoperiod: 16 hours of light and 8 hours of darkness

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

No immobilised Daphnia were observed at this dose level. No immobilised animals were reported in the control group.

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 48 h EC50 of the substance in Daphnia magna was determined to be >100 mg a.i./L.

Executive summary:

A study was conducted to determine the short-term toxicity of the substance to aquatic invertebrates according to OECD Guideline 202, in compliance with GLP. Based on a range-finding study, Daphnia magna were exposed to a concentration of 100 mg/L of the test substance for 48 h. Total organic carbon (TOC) concentrations were measured with a TOC analyser and the test substance was considered stable over the duration of the test. No immobilised Daphnia were observed at this dose level. No immobilised animals were reported in the control group. Under the study conditions, the 48 h EC50 of the substance in Daphnia magna was determined to be >100 mg a.i./L (Giarei, 2016).

Description of key information

A study was conducted to determine the short-term toxicity of the substance to Daphnia according to OECD Guideline 202, in compliance with GLP. 

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

> 100 mg/L

Additional information

A study was conducted to determine the short-term toxicity of the substance to aquatic invertebrates according to OECD Guideline 202, in compliance with GLP. Based on a range-finding study, Daphnia magna were exposed to a concentration of 100 mg/L of the test substance for 48 h. Total organic carbon (TOC) concentrations were measured with a TOC analyser and the test substance was considered stable over the duration of the test. No immobilised Daphnia were observed at this dose level. No immobilised animals were reported in the control group. Under the study conditions, the 48 h EC50 of the substance in Daphnia magna was determined to be >100 mg a.i./L (Giarei, 2016).