2,2'-(octadecylimino)bisethanol

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

18-12-2009 - 24-4-2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, well conducted. No major restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report Date:

2009

Materials and methods

Test guideline

Qualifier:

according to

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. certificate)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Chemical name:N-Alkyl "oleyl" N, N-bishydroxyethylamine
CAS number: 13127-82-7
EC number: 236-062-2
Batch number/Supplier:11747
Date of reception in the test facility:30/09/08
Expiration date of the test item:29/09/11
Attributed GRL number:0053/08

Main characteristics:
- appearance:Pale yellow liquid at 20°C
- purity:98%
- water solubility:Insoluble according to SDS
- relative density at 20°C:0.906
- certificate of analysis reference: See attached report

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Storage of samples: samples were analysed immediately after sampling without storage.
Samples treatment: samples were diluted in methanol.

Test solutions

Vehicle:

no

Details on test solutions:

A stock solution 5 mg/L CECAJEL 210 at was prepared on the day when the test was started and then on each day the solutions were renewed, Ie. after 24, 48 and 72 hours. Solutions were prepared by mixing 10 mg of the test item in 2 litres of dilution water and diluted in order to achieve the
desired range of concentrations.

The appearance of the test solutions was visually checked at the beginning and at the end of the test. Solutions were found to be clear, colourless \
over the period of the test. No precipitation was observed at the end of the test

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

The organisms used for the test were Dania rerio (Teleostei, Cyprinidae). Batch n° 09/Br/02/1 was supplied by Elevage de la Grande Riviere
(69490 Saint-Forgeux). The fish were placed under the test conditions (medium, identical or lower biological loading, temperature, lighting, etc.) 20
days before the beginning of the test. The fish selected for the test were all from the same batch and were of the same age (date of birth stated by the supplier: 20/08/08). Their size (determined by measuring 10 randomly sampled fish) was 3.2 ± 0.18 cm. The mortality in the aquarium containing
the batch of fish used for the tests was less than 5 % (observed mortality: 0 %) over the 7 days preceding the test.

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Test temperature:

22.4 ± 0.5 °C

pH:

7.43-8.05

Dissolved oxygen:

Did not fall below 77 % saturation.

Nominal and measured concentrations:

0.500, 0.370, 0.274, 0.203 and 0.151 mg/L (Nominal)

Details on test conditions:

The study was carried out in a thermostatically controlled room. The temperature, which was measured on a continuous basis in a test flask, was 22.4 ± 0.5 °C. The room was equipped with a programmed lighting system which produced a controlled lighting sequence: intensity between 400 and
800 lux at the surface of the aquaria; photo-period of 12 hours of darkness per 24 h. Physico-chemical parameters were measured using a
METTLER TOLEDO 345 pH-meter for measurement of pH and with a WTW OXI 538 oxymeter for dissolved oxygen measurement. The study was
performed using aquariums with a nominal capacity of 5 Iitres, covered with Altuglas®cover plates drilled with holes to allow the test solutions to be
aerated. Volume of test medium per aquarium was 2.5 L.

At the beginning of the test, appropriate volumes of the stock solution of CECAJEL 210 (nominal concentration 5 mg/L) were poured directly into the test aquarium, which were topped up with dilution water to obtain the above mentioned range of nominal concentrations (without pH-adjustment).

Number of fish :10 for each test concentration and for the control (2 replicates). The definitive test was carried out under semi-static conditions.
Five fish were added in each test aquarium which were covered and incubated. Two aquaria were prepared for each
concentration. The fish were examined after 1 hour and at intervals not exceeding 24 hours. They were considered to be dead if no reaction was
obtained when their caudal peduncle was stimulated and if no respiratory movement was observed. The visible anomalies were noted,
as were any sub-lethal effects such as loss of balance, pigmentation, changes in swimming behaviour, respiratory distress, etc.

Solutions were renewed after 24, 48 and 72 hours and physical parameters were measured daily.

Reference substance (positive control):

yes

Remarks:

Conducted on every fish batch

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 0.29 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Effect concentrations 2

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

0.25 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95 %(0.24-0.28)

Effect concentrations 3

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

0.14 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: 95% (0.11-0.18)

Effect concentrations 4

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.1 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: ND

Details on results:

The test chemical displays significant toxicity to fish.

Results with reference substance (positive control):

The sensitivity of the test organisms was checked at least once for each new batch of fish, by determining the LC50-24h of the potassium
dichromate. The results of the last test, carried out on 12/03/09, indicated a LC50-24h of 250 mglL. For reference, the former AFNOR standard
NF T 90-303 states that the LC5Q-24h of thepotassium dichromate with respect to Dania rerio must be between 200 and 400 mglL. The fish batch
was considered acceptable for testing.

Reported statistics and error estimates:

The mortality data are analyzed using an Excel sheet program. It was designed to calculate the LC50 value and the 95% confidence interval. Probit
analysis is generally used to calculate the 24-, 48-, 72 and 96-hour LC50 values.

Any other information on results incl. tables

Percentage Mortality

Nominal mg/L	Mean Measured mg/L	24	48	72	96
0.50	0.29	0	70	100	100
0.37	0.22	0	30	90	100
0.27	0.14	0	0	30	60
0.20	0.09	0	0	10	20
0.15	0.05	0	0	0	10
Control	-	0	0	0	0

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

This study can be considered reliable without restriction but the identity of the test substance has been clarified.

Executive summary:

Test well conducted with in general with validated analytical method ,GLP accreditation and analytical certificate. CAS number is contradictory will need clarifying. May be a toxicity overestmation for risk assesment purposes. Suitable for classification and labeling. Some minor discrepancies. Can be considered reliable without significant restrictions.