Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
other information
Study period:
January 22,2007 to March 28,2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
- Commission Directive 92/69/EEC, Annex Part C, C. 1:"Acute Toxicity for Fish", Official Journal of the European Communities No. L 383 A, dated December 29, 1992 - OECD Guideline for Testing of Chemicals, Section 2, No. 203: "Fish, Acute Toxicity Test", adopted July 17, 1992 - 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:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
and EU Method C.1 (Acute Toxicity for Fish)
Deviations:
yes
Remarks:
No aged media was taken at the end of the study where all fish are dead to measure the concentration. No effect on the study is assumed as the fish were already dead after 30min no changes were assumed in the test media.
GLP compliance:
yes (incl. QA statement)

Test material

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
Aggregate State at Room Temperature: Liquid
Colour: Brown (according to BACON personnel)
Stability: Technical product, In water: the test item is considered to be stable under test
conditions
Expiry Date: July 03,2007
Storage: In original container, at 2-8 degree C, in the dark



Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
13.27 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
5.5 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
22 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
3.8 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
5.5 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)

Any other information on results incl. tables

Sublethal observations / clinical signs:

Analytical Method:

The test item was analysed using a TOC method.

 

Analytical Results:

At the start of the test just before introduction of the fish 39%

of the nominal test concentration was found (mean value of all

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, this reduced findings are not surprising. In the aged

test media 58% of the nominal value was determined (mean

value of all test concentrations). Thus, during the test period the

fish were exposed to a mean of 48% of nominal (mean value of

all test concentrations). Therefore, all reported results are

related to the mean concentration of the test item.

TOC analysis can not 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.

Validity Criteria of the Study:

Control: In the control no fish died until the end of the test.

Dissolved Oxygen Concentration: The dissolved oxygen concentration in the test media did not

fall below 60% of air saturation value during the test.

 

Biological Results:

Signs of Intoxication: In the control and at the test concentrations of 3.8 and 5.5 mg

test item/l mean measured concentration (MMC) all fish

survived until the end of the test. In contrast, in the test

concentration of 11 mg test item/l MMC two fish died after

72 hours and all fish died in the test concentration of 22 and

48 mg test item/l MMC after 24 and 2 hours of exposure,

respectively. The surviving fish showed several signsof

intoxication, e.g. strong ventilation, dark colouration, apathy,

fish lying on the side or back on the bottomofthe aquaria,

from the test concentrationof 5.5 mg test item/l MMC up to

the highest.

 

Measured Test Parameter:

pH-Values of the Test Water: pH 7.8 to 7.9

Dissolved Oxygen Concentrations: At least 8.9 mg/L or higher

Water Temperature: 14 to 15 degree C

Light Intensity: 410-580 lux

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In the control and at the test concentrations of 3.8 and 5.5 mg test item/l mean measured concentration (MMC) all fish survived until the end of the test. In contrast, in the test concentration of 11 mg test item/l MMC two fish died after 72 hours and all fish died in the test concentration of 22 and 48 mg test item/l MMC after 24 and 2 hours of exposure, respectively. The surviving fish showed several signs of intoxication, e.g. strong ventilation, dark colouration, apathy, fish lying on the side or back on the bottom of the aquaria, from the test concentration of 5.5 mg test item/l MMC up to the highest.
Executive summary:

Title:

Acute Toxicity of CAT-Acid Chloride to Rainbow Trout (Oncorhynchus mykiss) in a 96-hour Static Test

 

Guidelines/Recommendations:

- Commission Directive 92/69/EEC, Annex Part C,

C. 1:"Acute Toxicity for Fish", Official Journal of the

European Communities No. L 383 A, dated December 29,

1992

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

203: "Fish, Acute Toxicity Test", adopted July 17, 1992

- 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 study was to evaluate the acute toxicity of

the test item CAT-Acid Chloride to fish. For this purpose,

juvenile Rainbow trout were exposed in a static test to aqueous

test media containing the test item at various concentrations

under defined conditions. The recorded effects were mortality

and symptoms of intoxication of the fish. A dose-response test

was performed in order to determine the relationship between

any effects seen and increasing test concentrations so that an

LC50 value could be determined.

The used method is recommended by the test guidelines, and

also Rainbow trout is one of the fish species recommended by

the international test guidelines of the OECD and EEC.

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 24

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.

 

Water Hardness:

2.5 mmol/l (= 250.0 mg/l) as CaC03

Test Concentrations:

Filtrate of nominal 100 mg test item and 1:2, 1:4, 1:8, 1:16

dilutions of a filtrated stock solution of nominal 100 mg test

item (corresponding to mean measured concentration (MMC)

values of 48, 22, 11, 5.5, 3.8 mg test item) and a control.

 

Biological Results:

96-hour LC50: 13.27 mg test item/l MMC

95% Confidence Intervals: 11.74-15.01 mg test item/l MMC

96-hour LC0: 5.5 mg test item/l MMC

96-hour LC100: 22 mg test item/l MMC

96-hour NOEC: 3.8 mg test item/l MMC

96-hour LOEC: 5.5 mg test item/l MMC

 

Analytical Method:

The test item was analysed using a TOC method.

 

Analytical Results:

At the start of the test just before introduction of the fish 39 %

of the nominal test concentration was found (mean value of all

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, this reduced findings are not surprising. In the aged

test media 58 % of the nominal value was determined (mean

value of all test concentrations). Thus, during the test period the

fish were exposed to a mean of 48% of nominal (mean value of

all test concentrations). Therefore, all reported results are

related to the mean concentration of the test item.

TOC analysis can not 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.

 

Validity Criteria of the Study

Control: In the control no fish died until the end of the test.

Dissolved Oxygen Concentration: The dissolved oxygen concentration in the test media did not

fall below 60% of air saturation value during the test.

 

Biological Results

Signs of Intoxication: In the control and at the test concentrations of 3.8 and 5.5 mg

test item/l mean measured concentration (MMC) all fish

survived until the end of the test. In contrast, in the test

concentration of 11 mg test item/l MMC two fish died after

72 hours and all fish died in the test concentration of 22 and

48 mg test item/l MMC after 24 and 2 hours of exposure,

respectively. The surviving fish showed several signs of

intoxication, e.g. strong ventilation, dark colouration, apathy,

fish lying on the side or back on the bottom of the aquaria,

from the test concentration of 5.5 mg test item/l MMC up to

the highest.

 

Measured Test Parameter

pH-Values of the Test Water: pH 7.8 to 7.9

Dissolved Oxygen Concentrations: At least 8.9 mg/L or higher

Water Temperature: 14 to 15 degree C

Light Intensity: 410 - 580 lux

 

Conclusion: 

In the control and at the test concentrations of 3.8 and 5.5 mg test item/l mean

measured concentration (MMC) all fish survived until the end of the test. In contrast, in the test concentration of 11 mg test item/l MMC two fish died after 72 hours and all fish died in the test concentration of 22 and 48 mg test item/l MMC after 24 and 2 hours of exposure, respectively. The surviving fish showed several signs of intoxication, e.g. strong ventilation, dark colouration, apathy, fish lying on the side or back on the bottom of the aquaria, from the test concentration of 5.5 mg test item/l MMC up to the highest.