1-(2-ethylbutyl)cyclohexanecarbonyl chloride

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

other information

Study period:

Januaiy 3 1,2007 to October 06,2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

- Commission Directive 92/69/EEC, Annex Part C, C.3: "Algal Inhibition Test", Official Journal of the European Communities No. L 3 83 A, dated December 29, 1992. - OECD Guideline for Testing of Chemicals, Section 2, No. 201: "Freshwater Alga and Cyanobacteria, Growth Inhibition Test", adopted March 23, 2006. - OECD Series on Testing and Assessment, No. 23, "Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures", December 15, 2000.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

Version / remarks:

and EU Method C.3 (Algal Inhibition test)

Deviations:

yes

Remarks:

In the 1:33 dilution (0.85 mg test item/l nominal) only 2 replicates could be used for the evaluation of the results due to contamination. No effect on the study is presumed.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

CAT - Acid chloride

IUPAC Name:

CAT - Acid chloride

Details on test material:

Name: CAT - Acid chloride
Certificate of Analysis Date: March 30,2006
Type: Active ingredient of a pharmaceutical
Aggregate State at Room Temperature: Liquid (according to BACON personnel)
Colour: Brown (according to BACON personnel)
Stability: Technical product: see expiry date
Expiry Date: July 03,2007
Storage: In original container, in the refrigerator (2-8 degree C), in the dark.
Safety Precautions: Routine safety and hygienic procedures.

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

yes

Test organisms

Test organisms (species):

Desmodesmus subspicatus (previous name: Scenedesmus subspicatus)

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

72 h

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 31 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 2

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 31 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

biomass

Effect concentrations 3

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 31 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

other: Yield

Effect concentrations 4

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

> 31 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 5

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

> 31 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

biomass

Effect concentrations 6

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

> 31 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

other: Yield

Effect concentrations 7

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

> 31 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 8

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

> 31 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

biomass

Effect concentrations 9

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

> 31 mg/L

Nominal / measured:

meas. (initial)

Conc. based on:

test mat.

Basis for effect:

other: Yield

Any other information on results incl. tables

Analytical Results:

At the start of the test 30% of the nominal test concentration was

found (mean value of the three highest test concentrations). This

calculation based on nominal test concentrations not considering the

fact that the test media were filtrated to remove the non-dissolved

part of the test item. Therefore, these reduced findings are not

surprising. In the aged test media 26% of the nominal value was

determined (mean value of the two highest test concentrations).

 

Thus, during the test period the algae were exposed to a mean of

28% of nominal (mean value of all measured test concentrations).

The results of the two highest concentrations (filtrate and one

dilution) are expressed in terms of mean measured concentrations of

the test item. For the three lowest concentrations, under the limit of

quantification, the concentration was calculated by multiplying the

nominal value with the overall mean recovery of all measured test

concentrations (28%).

TOC analysis cannot differ between test item and degradation

products (both of them contribute to the signal, which is evaluated).

However, for the calculation of the recovery rate this has not to be

considered.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The influence of CAT - Acid chloride on the growth of the
freshwater green algal species Desmodesmus subspicatus was
assessed in a static dose-response test.
Up to the highest concentration, a filtrate of 100 mg test item
corresponding to a mean measured concentration of 31 mg test
item no effects on yield, growth rate and biomass occurred.
The overall NOEC was determined to be 100 mg test item/l
corresponding to a mean measured concentration of 31 mg test
item/l, the overall LOEC was determined to be higher than 100 mg
test item/l corresponding to a mean measured concentration of 31 mg
test item/l.

Executive summary:

Title:

Toxicity of CAT - Acid chloride to Desmodesmus subspicatus in an

Algal Growth Inhibition Test

 

Guidelines/Recommendations:

- Commission Directive 92/69/EEC, Annex Part C, C.3: "Algal

Inhibition Test", Official Journal of the European Communities

No. L 3 83 A, dated December 29, 1992.

- OECD Guideline for Testing of Chemicals, Section 2, No. 201:

"Freshwater Alga and Cyanobacteria, Growth Inhibition Test",

adopted March 23, 2006.

- OECD Series on Testing and Assessment, No. 23, "Guidance

Document on Aquatic Toxicity Testing of Difficult Substances

and Mixtures", December 15, 2000.

 

Purpose:

The purpose of this test was to determine the inhibitory effect of the

test item CAT - Acid chloride on the growth of the freshwater green

algal species Desmodesmus subspicatus.

Exponentially growing cultures of this unicellular green algal

species were exposed to various concentrations of the test item

under defined conditions. The inhibition of growth in relation to

control cultures was determined over a test period of 72 hours, and

thus over several algal generations.

The test method of application and the test system are recommended

by the test guidelines and Desmodesmus subspicatus is one of the

recommended test species.

Since the test item is instable and insoluble in test water, it was

tested according to OECD No. 23 (Testing of Difficult Substances).

Therefore, the stock solution was stirred for 25 hours, in order to

make allowance for the water insolubility of the test item. The non-dissolved

part of the test item was afterwards removed by filtration.

Due to the instability of the test item, mainly the degradation

products were tested.

The purpose of the analytical part of this study was to measure the

dissolved part of the test item and/or its degradation products using

measurement of Total Organic Carbon (TOC) as sum parameter.

Test Concentrations:

Filtrate of nominal 100 mg test item/l and 1:3.2, l:l0, 1:33, and 1:105

dilutions of this filtrate (corresponding to mean measured values of

31, 7.8, 2.8, 0.85, 0.27 mg test item/l). Additionally, a control was

tested in parallel (test water without addition of the test item).

Analytical Method:

The test item was analysed using a TOC method.

 

Analytical Results:

At the start of the test 30% of the nominal test concentration was

found (mean value of the three highest test concentrations). This

calculation based on nominal test concentrations not considering the

fact that the test media were filtrated to remove the non-dissolved

part of the test item. Therefore, these reduced findings are not

surprising. In the aged test media 26% of the nominal value was

determined (mean value of the two highest test concentrations).

 

Thus, during the test period the algae were exposed to a mean of

28% of nominal (mean value of all measured test concentrations).

The results of the two highest concentrations (filtrate and one

dilution) are expressed in terms of mean measured concentrations of

the test item. For the three lowest concentrations, under the limit of

quantification, the concentration was calculated by multiplying the

nominal value with the overall mean recovery of all measured test

concentrations (28%).

TOC analysis cannot differ between test item and degradation

products (both of them contribute to the signal, which is evaluated).

However, for the calculation of the recovery rate this has not to be

considered.

 

Conclusion:

The influence ofCAT- Acid chloride on the growth of the

freshwater green algal species Desmodesmus subspicatus was

assessed in a static dose-response test.

Upto the highest concentration, a filtrate of 100 mg test item

corresponding to a mean measured concentration of 31 mg test

item no effects on yield, growth rate and biomass occurred.

The overall NOEC was determined to be 100 mg test item/l

corresponding to a mean measured concentration of 31 mg test

item/l, the overall LOEC was determined to be higher than 100 mg

test item/l corresponding to a mean measured concentration of 31mg

test item/l.