Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 February - 23 March 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed according to GLP adn OECD guidelines. No monitoring of concentration, but substance fully watersoluble.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
yes
Remarks:
No measurements of concentrations.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
The test material was identified by name and specifications:
- chemical name: Cocobis(2-hydroxyethyl)amine oxide
- cas nr : 61791-47-7
- batch no: 900110 (CoA attached to the report):
Amine oxide: 30.5%
Free amine: 0.3%
Free peroxide: 0.13%

It was supplied by the study sponsor on 5 Feb 1990. Stored in the dark at room temperature.
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Liquid. Stable at test conditions (biodegradability information available).
Water soluble at test concentrations

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
The test solutions were prepared from stock solutions of the test substance in deionized water. The stock solution was prepared by intensive mixing and was homogeneous. The test concentrations were prepared by addition of the respective amounts of the stock solution to the
DutchStandardWater (DSW).

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Obtained from a local aquarium retailer and identified by batch 20-2-90. The fish were appromiximately 2.5-3.0 cm in size and the medium wet
weight per fish was approximately 0.3 g. Before being used in the test, the fish were kept for at least 12 days in the facilities to determine the
acceptability of the batch. The water they were kept in was Dutch Standard Water (DSW).

The fish were fed daily, the last feeding taking place 24 hours before the start of the test.



Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
None

Test conditions

Hardness:
13 dH
Test temperature:
22 -23 C
pH:
7.3 - 7.7
Dissolved oxygen:
3.2 - 7.8 mg/l (36% - 87% oxygen of air saturation value). The low oxygen values would not have affected the study outcome,
namely also in control groups (no exposure and reference substance) low oxygen was measured, but did not affect mortality.
Nominal and measured concentrations:
Nominal concentrations:
6.0 - 8.4 - 11.8 - 16.5 - 23.0 mg/L
Details on test conditions:
10 fish were used per test concentration and control: approximately 1.0 g biomass/L.

As test vessels 5 L glass aquaria containing 3L of test medium were used, which were covered with a plass plate. The diluting water used for
preparation of the test concentrations was a synthetic water: Dutch Standard Water (pH= 8.2, hardness: 13 dH).

The test was carried out in a temperature controlled incubator. The light regime was 12 hours of ambient light per day, provided by fluorescent
tubes. Oxygen and pH were measured daily.
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
3.4 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 95% CI 3.1-3.8 mg/L
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
11.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95% CI 10.1 - 12.5 mg/L
Details on results:
The LC50 (96h) was calculated to be 11.2 mg/L with 95% confidence limits of 10.1 and 12.5 mg/L. The highest concentration causing no mortality
(No Observed Effect Concentration, NOEC) after 96 hours amounted to 8.4 mg/L, whereas 100% mortality was produced within 23 hours at 16.5
mg/L. No other effects (deviations in behaviour or appearance) were obeserved at non lethal dose rates.
Results with reference substance (positive control):
The LC50 for potassium dichromate was calculated to be:
mg/L (95% CL)
24h: 396 (197 -796)
48h: 210 (193 - 229)
72h: 198 (150 - 262)
96h: 198 (150 - 262)
which is in line with a reference EEC study stating a mean value for LC50(48h) of 205.5 mg/L.
Reported statistics and error estimates:
The LC50 was determined with a LC50 programme of Griffioen (RIZA, NL) based on a model by Kooyman (1981).

Any other information on results incl. tables

Number of surviving animals

Conc (mg/L)

0h

5h

23h

29h

46h

48h

53h

70h

72h

90h

94h

96h

Control

10

10

10

10

10

10

10

10

10

10

10

10

6.0

10

10

10

10

10

10

10

10

10

10

10

10

8.4

10

10

10

10

10

10

10

10

10

10

10

10

11.8

10

10

9

9

9

9

7

5

5

4

2

2

16.5

10

7

0

0

23.0

10

0*

0*

* Unclear for timepoint

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The LC50(96h) was calculated to be 11.2 mg/L with 95% confidence limits of 10.1 and 12.5 mg/L. the NOEC was 8.4 mg/L. If it is assumed that the product has a 100% pure active ingredient and that the toxicity is related to the active ingredient only, the LC50 and NOEC (96h) amounts to 3.4 and
2.6 mg/L amine oxide respectively.
Executive summary:

A study was performed according to OECD203 and GLP to investigate the acute toxicity of the test item to fish. The study was semi-static and was performed also using a reference substance (potassium dichromate). Based on nominal concentrations only, the LC50 was calculated to be 11.2 mg/L and the NOEC was 8.4 mg/L. The reference substance showed the acceptability of both the test system and batch of fish. No other effects such as deviations in behaviour or appearance of the fish were observed in non-lethal concentrations.