1-[(tert-butoxycarbonyl)amino]cyclobutane-1-carboxylic acid

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:

12 Apr 2021 to 16 Apr 2021

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

June 2019

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: MEP, P.R. China, the Guidelines for the Testing of Chemicals, Effects on Biotic Systems, No. 203 “Fish Acute Toxicity Test”.

Version / remarks:

MEP, P.R. China, the Guidelines for the Testing of Chemicals, Effects on Biotic Systems, No.
203 “Fish Acute Toxicity Test”.

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: SANCO/12571/2013

Version / remarks:

November 2013 rev.0, Implemented by 01/01/2014

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-[(tert-butoxycarbonyl)amino]cyclobutane-1-carboxylic acid

EC Number:

627-199-2

Cas Number:

120728-10-1

Molecular formula:

C10H17NO4

IUPAC Name:

1-[(tert-butoxycarbonyl)amino]cyclobutane-1-carboxylic acid

Test material form:

solid: particulate/powder

Details on test material:

Physical state: powder
Appearance: white powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: AC07N2005001
- Expiration date of the lot/batch: 2021-05-31 (retest date)
- Purity: 99.9%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature protected from light

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Samples were taken for LC-MS analysis at the start of the test, 48 hours (fresh and old) and at the end of the test (fresh and old). About 20 mL sample was taken from the test solution and control solution.

Test solutions

Vehicle:

no

Details on test solutions:

According to the results of the range-finding test, the definitive test was carried out as a limit test at a nominal concentration of 100 mg/L, a blank control group was conducted concurrently. The details were as follows:
-Test concentration: 100 mg/L, a control group was conducted concurrently.
-Blank Control: Test medium without test item or other additives
Preparation of test solutions:
0.5009 g and 0.5007 g of test item (used for two batches of preparation) were weighed and dissolved in 5 L of test water by magnetic stirring for about 1.5 hours. After the test item was completely dissolved, the solution was used for exposure.

Test organisms

Test organisms (species):

other: Rare Minnow (Gobiocypris rarus)

Details on test organisms:

Test organism name: Rare Minnow (Gobiocypris rarus)
Batch No.: Rare Minnow 20210119
Origin: The fish were reproduced in this facility.
Their parental generation was introduced from CTI Chemical Safety Evaluation Research Center (SUZHOU) CO., LTD.
Reason for the selection of the test system: This system has been selected as a recommended s
pecies of MEP, P.R. China Guideline for the Testing of Chemicals No.203
total length: 1.85 - 2.00 cm
body weight: 0.0812-0.1006 g
Holding Conditions:
Acclimation: From hatching, there were no signs of disease or significant numbers of mortality.
During the acclimating period, the fish were held in identical water quality and illumination conditions as used in the test.
Feeding: twice a day on weekdays and once a day during the weekends, until 24 hrs before the start of the test

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

180 mg/L (as CaCO3)

Test temperature:

24.4 - 25.0 °C.

pH:

6.85 to 8.0

Dissolved oxygen:

80.5-106.4% (ASV)

Salinity:

not relevant

Conductivity:

not specified

Nominal and measured concentrations:

nominal concentration: 100 mg/L

The arithmetic mean of fresh media at the start of the test and at the 48-hr renewal was 109 mg/L (109% of nominal concentration), and the arithmetic mean of 48-hr old media at the renewal and end of the test was 105 mg/L (105% of nominal concentration): the test concentrations were satisfactorily maintained in the range of 80-120% of nominal concentrations; see also table below in 'Any other information on materials and methods incl. tables'

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass bottles
- Material, size: diameter: 16 cm, height: 26 cm
- volume: 5L
- Aeration: not during the test
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.1321 g fish/L, i.e. 0.6605 g per 5 liter of medium
OTHER TEST CONDITIONS
- Photoperiod: 16h light daily: 8 hours darkness and an intensity of 540 - 1000 lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Fish were considered to be dead when no reaction was observed after touching the caudal peduncle and visible breathing movements were absent.
TEST CONCENTRATIONS
- Spacing factor for test concentrations: none (limit test)
- Range finding study: yes
- Test concentrations:1.0, 10, 50 and 100 mg/L
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Mortality of control: none
- Other adverse effects control: no
- Abnormal responses: none

Results with reference substance (positive control):

- Results with reference substance valid? yes
- LC50: 24-h LC50 = 299.86 mg/L.

Reported statistics and error estimates:

no statistical method was adopted, as the test was a limit test

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of T003661 to Rare Minnow (Gobiocypris rarus) was determined in a 96 hour static limit test according to the OECD guideline 203. The 96-h LC50 was >100 mg/L