N-(1-oxooctyl)glycine

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-(1-oxooctyl)glycine

EC Number:

238-122-3

EC Name:

N-(1-oxooctyl)glycine

Cas Number:

14246-53-8

Molecular formula:

C10H19NO3

IUPAC Name:

N-(1-oxooctyl)glycine

Details on test material:

- Name of test material (as cited in study report): LCA07012
- Substance type: mono-constituant
- Physical state: solid
- Analytical purity: >97%
- Lot/batch No.: 716300006
- Expiration date of the lot/batch: 11.06.2010
- Stability under test conditions: yes
- Storage condition of test material: room temperature (20 ± 5 °C)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting point: 105-110°C
- Vapour pressure: 1.33*10-4Pa
- log Pow: 2.052 ± 0.023

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

none

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Test System HPLC DIONEX with UV-Detector, DIONEX
Column: Reprosil 100 C18 4.6*150mm (Dr.Maisch)
Mobile phase: mixture of 50 % CH3CN, 50 % H2O (pH 2.0)
Flow rate: 1 mL/min.
Column temperature: 25 °C
Detection λ: 200 nm
Injection volume: 20 µL
Retention Time Test Item: 3.1 – 3.8 min.

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: danio rerio
- Strain: HAMILTON-BUCHANAN
- Age at study initiation (mean and range, SD): sexually immature young fish, length 2.1 cm
temperature: 23.5°C



ACCLIMATION
- Acclimation period:14 days
- Acclimation conditions (same as test or not):same as the study
- Type and amount of food:warmwater fishfood and daphnia
- Feeding frequency: three times a day with warmwater fishfood and daphnia, totalling to about 1-2% of body weight per day
- Health during acclimation (any mortality observed):the mortality not surpassing 5%

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

mortality

Test conditions

Hardness:

24 hours before the start of the test, food was withheld from the designated test fish.
Medium renewal every 24 ± 1 hours
Duration 96 hours
Loading 1 fish/L
Vessels: glass aquaria, maximal volume 10 L
Aeration: accomplished with glass tubes, frequency of bubbles 1/s
Feeding: none
Photo period: 12/12 hours using neon tubes
Temperature: 23 ± 1 oC
pH adjustment: none
Replicates: one vessel for each treatment and for the control
Observations were made every 24 hours, measuring pH and O2-concentration of the old and new test solution in each vessel and documentating mortalities or abnormal behav-iour. In the main study the content of the test item in the test vessels was measured at every medium renewal in the old and the new test solutions.
A fish was considered dead, if no visible movement could be observed, and if touching of the caudal peduncle produced no reaction.

Test temperature:

Temperature range was 20.3 – 20.4 °C.
Nominal Concentration in mg/L pH at t in h (old/new test solution)
0 h 24 h 48 h 72 h 96 h
new old new old new old new old
0 8,1 8,0 8,4 7,9 8,2 7,8 8,1 7,8
100 7,0 7,9 7,1 7,8 7,9 7,4 7,9 7,4

pH:

7.0 to 8.4.

Dissolved oxygen:

Nominal Concentration in mg/L O2 in mg/L at t in h (old/new test solution)
0 h 24 h 48 h 72 h 96 h
new old new old new old new old
0 9.0 8.0 8.8 8,0 9,2 8,1 9,0 9,8
100 8,8 8,1 8,4 7,9 9,1 6,7 9,3 8,4
. The concentration of dissolved oxygen stayed above 8.4 mg/L or 93 % throughout the test

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Any other information on results incl. tables

Sublethal observations / clinical signs:

The biological results are presented in the following table:

     Biological Results

Parameter	Value	95%-confidence-interval
24h NOEC	100 mg/L	not determinable
24h LC50	> 100 mg/L	not determinable
24h LC100	>> 100 mg/L	not determinable
48h NOEC	100 mg/L	not determinable
48h LC50	> 100 mg/L	not determinable
48h LC100	>> 100 mg/L	not determinable
72h NOEC	100 mg/L	not determinable
72h LC50	> 100 mg/L	not determinable
72h LC100	>> 100 mg/L	not determinable
96h NOEC	100 mg/L	not determinable
96h LC50	> 100 mg/L	not determinable
96h LC100	>> 100 mg/L	not determinable

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

• The mortality in the control may not exceed 1 fish at the end of the test.
No mortalities occurred in the control.
• The dissolved oxygen concentration must be at least 60% throughout the test.
The concentration of dissolved oxygen stayed above 6.9 mg/L or 81 % throughout the test (100 % at 101300 Pa equals 8.57 mg/L, following DIN 38408 part 22).
• The pH-value in the test solutions should not vary more than 1 unit during the test.
The highest variation was 0.9 units.

Executive summary:

In a pre-test, the concetrations 100; 10 and 1 mg/L were tested in a static performance. For each concentration, three fish were exposed to the test item for 96 hours.

The main study was performed as a limit test using a nominal concentration of 100 mg/L in a semi static test with medium renewal every 24 hours.

No mortality was observed in the treatment and the control, no fish showed any signs of morbidity at the end of the test. The pH and the oxygen values of the water were normal.

At every medium renewal, the content of the test item in the old and the new test solutions was determined using HPLC. The recovery after 24 hours lay in a range between 93 and 102 % of the start concentration and the correlation between nominal and measured concentration was very good (100 – 112 %). Therefore, the determination of the results was based on the nominal concentration.

The following results for the test itemLCA07012could be determined:

 

96h NOEC = 100 mg/L

96h LC50 > 100 mg/L