Alcohols, lanolin

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

24 July 2001

Test material

Test material information

Constituent 1

Reference substance name:

Lanolin Alcohols

IUPAC Name:

Lanolin Alcohols

Constituent 2

Reference substance name:

Alcohols, lanolin

EC Number:

232-430-1

EC Name:

Alcohols, lanolin

Cas Number:

8027-33-6

Molecular formula:

UVCB

IUPAC Name:

Alcohols, lanolin

Details on test material:

Sponsor's identification: Wollwachsalkohol I Lanolinalkohol
Description: Yellow, type wax
Batch number: Eucerit 6480
Active ingredient: Wool waxalcohol
Storage conditions: 7 ± 2 °C, protected from light and moisture
Composition: Aliphates: 25.5 %
Sterines: 60.6 %
Cholesterine: 31.2 %
CH-5dien-70ne: 8.9 %
Dehydrolanosterine: 5.5 %
Lanosterine: 10.9 %

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations:
Nominal: 100 mg/L

- Sampling method:
not reported

- Sample storage conditions before analysis:
not stated

Test solutions

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION

Concentration: 100 mg/l
The test item was weighed in directly. An aliquot (300 mL) of 40 °C warm dilution water was added to the test item and treated with a laboratory blender (20000 rpm, 30 min). This suspension was applied to the dilution water and mixed with a laboratory blender (20000 rpm, 1 min).

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name:
Zebra fish

- Strain:
Not stated

- Source:
AQUARIUM AM AEGI, Feldstraße 7, D-30159 Hannover. All fish used in the test originated from the same delivery of the supplier.

- Age at study initiation (mean and range, SD):
not stated

- Length at study initiation (length definition, mean, range and SD):
2.8 cm

- Weight at study initiation (mean and range, SD):
0.20 g

- Method of breeding:
Not stated

- Feeding during test
The fish were not fed during the test.

- Food type:
Trouvit 40 / 2; MILKIVIT, D-86666 Bürgheim. The test fish were not fed until 24 h before the test started.

- Amount:
The amount of food was 4 % of the fish body weight per feeding day.

- Frequency:
Food was provided 3 times per week

ACCLIMATION
- Acclimation period:
At least 12 days

- Acclimation conditions (same as test or not):
Same as test conditions.

- Type and amount of food:
The stock fish were fed commercial trout pellets which was discontinued 24 hours prior to the start of the definitive test

- Feeding frequency:
Food was provided 3 times per week

- Health during acclimation (any mortality observed):
Mortality < 5 % within the last 7 days before the study starts.


QUARANTINE (wild caught)
- Duration:
Not applicable

- Health/mortality:
Not applicable

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

Observations were made after 24, 48, 72 and 96 h. Fish would have considered dead if there was no visible movement (e.g. gill covers movement) and if touching of the caudal peduncle produced no reaction. Records were kept of visible abnormalities (e.g. loss of equilibrium, swimming behaviour, respiratory function, pigmentation, etc.).

Test conditions

Hardness:

40 - 180 mg CaC03/L

Test temperature:

23 ± 2 °C

pH:

6.0 - 8.5

Dissolved oxygen:

Not less than 60 % of air saturation value.

Salinity:

No Data

Nominal and measured concentrations:

Nominal: 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
Glass-aquaria loosely covered by glass tops were used.

- Type (delete if not applicable):
closed

- Material, size, headspace, fill volume:
5 L per vessel

- Aeration:
Gentle aeration

- Type of flow-through (e.g. peristaltic or proportional diluter):
Not applicable

- Renewal rate of test solution (frequency/flow rate):
Not stated

- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

OTHER TEST CONDITIONS
- Adjustment of pH:
not reported

- Photoperiod:
A natural photoperiod was provided during the test.

- Light intensity:
0.1 - 10 µmol/m2 .s

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% confidence limits: Not applicable

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: 95 % Confidence limit: not stated

Details on results:

- Behavioural abnormalities:
None recorded.

- Observations on body length and weight:
None recorded

- Other biological observations:
None recorded

- Mortality of control:
None recorded

- Other adverse effects control:
None recorded

The test concentration of 100 mg/L (nominal concentration) caused no mortality or non lethal effects. Therefore the NOEC was laid down as 100 mg/L (nominal concentration).

Results with reference substance (positive control):

- Results with reference substance valid?
Not applicable

- Mortality:
Not applicable

- LC50:
Not applicable

- Other:
Not applicable

Reported statistics and error estimates:

None

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In this study Wollwachsalkohol/Lanolinalkohol was not found to be toxic to Zebra fish after 96 h at the nominal concentration 100 mg/L.

Executive summary:

The acute toxicity of the test item Wollwachsalkolhol/ lanolinalkohol to fish (zebra fish) was determined according to the OECD-Guideline for Testing of Chemicals No. 203 (1992) from 14 marhc 2001 to 18 March 2001 at DR.U.Noack Laboratorium Für Angewandte Biologie, 31157 Sarstedt, Germany.

A static limit test was conducted with the nominal concentration 100 mg/L selected on the basis of a preliminary range finding test.

Duration of the test was 96 h. 7 test organisms were exposed to the test concentration and the control.

The test item concentration showed turbidity and homogeneous distribution throughout the test.

All effect values are based on the nominal concentration of the test item. No concentration control analysis was carried out.

The acute toxicity of the test item Wollwachsalkohol / Lanolinalkohol is summarised in the following table:

Table: LC-Values with 95 % Confidence Intervals (based on nominal concentrations

Test duration [h]	LC50[mg/L]	p = 95%[mg/L]
24	> 100	not applicable
48	> 100	not applicable
72	> 100	not applicable
96	> 100	not applicable
LC100 =                                                          > 100 mg/L Lowest test item concentration                                 With 100 % mortality after 96 h
LC0 =                                                          > 100 mg/L Highest test item concentration                                 with 0 % mortality after 96 h

NOEC:

On the basis of the observations made during the test, the NOEC was determined at a concentration of 100 mg/L (nominal concentration) for the test item Wollwachsalkohol/Lanolinalkohol.

Water quality parameters of temperature, pH-value, oxygen-saturation measured after 0, 24, 48, 72 and 96 h were determined to be within the acceptable limits.