Reaction mass of 2- (palmitoylamino)ethyl acrylate and 2-(stearoylamino)ethyl acrylate

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

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 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: Provided by Sponsor; Lot number 91112Y
- Purity.: 92.4%


STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test sample was stored in a dark storage place at room temperature.
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: stability

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): The weighed test sample(0.304g) and dilution water(2.8L) were mixed to produce the nominal concentration of 100mg/L and stirred by a magnetic stirrer for 48 hours to prepare the test solution(suspension).

Analytical monitoring:

yes

Details on sampling:

Frequency of measurement:At the start and end of exposure
Sample for measurement: The test solution for analysis was taken out from the middle layer of the test vessel.
Volume of sample: Approximately 200mL(all test levels)

Vehicle:

no

Details on test solutions:

The weighed test sample(0.304g) and dilution water(2.8L) were mixed to produce the nominal concentration of 100mg/L and stirred by a magnetic stirrer for 48 hours to prepare the test solution(suspension).

Test organisms (species):

Oryzias latipes

Details on test organisms:

TEST ORGANISM
- Common name:Japanese Medaka
- Strain:Oryzias latipes
- Source: CERI Kurume(in-test facility production)
- Age at study initiation : two-month-old
- Length at study initiation :1-2cm
- Body weight 0.059 ±0.016g(0.036-0.079g)
- Method of breeding: Saturation volume， everyday

ACCLIMATION
- Acclimation period: 49 days
- Acclimation conditions (same as test or not): same
- Type and amount of food during acclimation: Saturation volume， everyday
- Health during acclimation (any mortality observed): no mortality


FEEDING DURING TEST (as applicable):no

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

40.1 mg CaCo3/L

Test temperature:

24.1℃-24.3℃

pH:

7.6-7.7

Dissolved oxygen:

8.0-8.3 mg/L

Nominal and measured concentrations:

nominal concentration : 100mg/L

Details on test conditions:

TEST SYSTEM
Test vessel： 3L glass tank(diameter：16cm， depth：17cm)
Cover on test vessel： Transparent plastic lid
Water bath： Plastic tank；Warming/cooling unit RX-401HPN-Z(IWAKI)

- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates):1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
Dechlorinated tap water， aerated sufficiently and temperature-controlled， was used.It was
confirmed that the concentration of residual chlorine in dilution water was ≤0.02mg/L at the use.
Chemical characteristics of dilution water measured regularly .The result of chemical characteristics of dilution water met the standard that was provided with the standard operating procedure of this test facility.


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: Room light， 16-hour light/8-hour dark(illuminance：540-1000 lx)


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS

- Test concentrations: 100mg/L

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Details on results:

No abnormal response in the exposure level during exposure was observed

Validity criteria fulfilled:

yes

Conclusions:

The 96h LC50 of the test item is >100 mg/L(nominal）.

Executive summary:

The 96 –hr-acute toxicity of test item to Oryzias latipes was studied under static conditions.  Test species were exposed to control, and test chemical at nominal concentration of 100 mg /L for 96 hr.  Mortality and sublethal effects were observed daily/at test termination.  The 96– hour LC₅₀was >100 mg /L(nominal).  No abnormal response in the exposure level during exposure was observed

 

Based on the results of this study, the test item would be not classified to Oryzias latipes.

This study is not classified and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.

Test Organism Age (e.g. 1^st instar):two-month-old

Test Type (Flowthrough, Static, Static Renewal):Static

 

LC₅₀:  > 100 mg /L  (nominal）                   

Description of key information

96h- LC50 >100 mg/L (GLP, OECD 203, Oryzias latipes)

 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L