Guerbet alcohols, C24-26, branched and cyclic

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish, juvenile growth test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June - September 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

This study was performed for the notification in other regions where authorities do not accept read-across data or QSAR.

Qualifier:

according to guideline

Guideline:

OECD Guideline 215 (Fish, Juvenile Growth Test)

Version / remarks:

January 21, 2000

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Sampling method: once a week, fresh and old media

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 1.00 g test item were weighed and added into a glass bottle filled with 10 l test water. The bottle was capped and the solution was stirred slowly by magnetic stirrer at a rate of 200-230 rpm for 48 +/- 1 hours and allowed to stand for 50-70 minutes. After der settling period, about 5 l of the solution was drawn off from the depth of about 7 cm above the bottom of the bottle and then used as test solution for exposure.
- Controls: concurrent water without test substance

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: own bred in the testing facility
- Weight at study initiation (mean and range, SD): 0.050-0.10 g
- Food type: brine shrimp nauplii, newly hatched
- Amount: 4% of body weight
- Frequency: once daily

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

28 d

Hardness:

190 mg/l (as CaCO3)

Test temperature:

21.1 - 23.1 °C

pH:

7.70 - 8.24

Dissolved oxygen:

75.9 - 99.8 %

Nominal and measured concentrations:

100 mg/l

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass bottles
- Size of vessel: diameter: 16 cm, height: 26 cm
- Renewal rate of test solution (frequency): daily
- No. of organisms per vessel: 10
- Loading rate: 0.2 -1.0 g fish/L
- Volume of test solution: 5 L
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


OTHER TEST CONDITIONS
- Photoperiod: 16 hours light, 8 hours darkness
- Test temperature: 21.1 - 23.1 °C

RANGE-FINDING STUDY
- Test concentrations: 1, 10 and 100 mg/l
- Test conditions: renewal of test solution every 2 or 3 days
- Results used to determine the conditions for the definitive study: No deaths and visible toxic signs were observed in the control and test groups. No specific differences between control and test group on pseudo-specific growth rate (fish weights of initial day and day 28)

Reference substance (positive control):

no

Key result

Duration:

28 d

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Key result

Duration:

28 d

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

weight

Details on results:

- Observed effects: see Table 1
- Cumulative mortality at each concentration and for each recommended observation time if possible: no deaths
- Mortality in the controls: no deaths
- Toxic signs: none in control and test groups
- Weights: The individual weights were in the range of 0.0752-0.0956g at the start. For the whole batch of fish used in the test, the range of individual weights at the start of the test was -12.0 % - + 11.8 % of the arithmetic mean weight (0.0855 g). After exposure for 28 d, the mean weight of fish in the control has increased by 136.6 %of their mean initial weight over 28 days, which met the validity criterion of the test. The mean weight of fish in the test group has increased by 124.8 % of their mean initial weight over 28 days. Compared with the average r3 for the control, the percent inhibition of the average r3 for the test group was 5.9%. The result of the two-sided Student t-test indicated that r3 did not display significant differences (p>0.05) between the control and the test group.

Reported statistics and error estimates:

Two-sided Student t-test with a 5% significance level was used to compare the pseudo-specific growth rate of the test group with the control and to obtain the lowest observed effect loading rate (LOEL) and the no observed effect loading rate (NOEL).

Table 1: Pseudo-specific growth rate r3 after 28 days in the main test

Loading rate	Control	100 mg/l
Fish 1 r3 (per day)	3.15 %	3.16 %
Fish 2 r3 (per day)	2.93 %	2.95 %
Fish 3 r3 (per day)	2.72 %	2.98 %
Fish 4 r3 (per day)	3.56 %	2.55 %
Fish 5 r3 (per day)	3.15 %	3.37 %
Fish 6 r3 (per day)	3.47 %	2.63 %
Fish 7 r3 (per day)	3.22 %	2.57 %
Fish 8 r3 (per day)	2.88 %	2.62 %
Fish 9 r3 (per day)	2.83 %	2.66 %
Fish 10 r3 (per day)	2.73 %	3.31 %
Arithmetic mean r3	3.06 %	2.88 %
Inhibition of r3 (%)	-	5.9 %
p-value (t-test)	-	0.20

Validity criteria fulfilled:

yes

Conclusions:

Based on the growth of juvenile zebra fish, the 28-day NOEL of the test substance Guerbet alcohols, 24-26, branched and cyclic was determined to be >= 100 mg/l and the 28-day LOEL was > 100 mg/l.

Executive summary:

A fish, juvenile growth test of Guerbet alcohols, 24-26, branched and cyclic was conducted with zebra fish (Danio rerio) over a 28-d exposure period at a loading rate of 100 mg/l. The test was performed under semi-static conditions and test solutions were renewed daily. During the 28-day exposure period, no deaths and visible toxic signs were observed in the control and the test group. At the start and the end, the fish were weighd individually as wet weights (blotted dry). The pseudo-specific growth rate "r3" was calculated to evaluate toxic effetcs. Two-sided Student t-test with a 5% significance level was used to compare "r3" of the test group with the control and to obtain the lowest observed effect loading rate (LOEL) and the no observed effect loading rate (NOEL). The result of the two-sided Student t-test indicated that r3 did not display significant differences (p> 0 .05) between the control and the test group.

Description of key information

A fish, juvenile growth test of Guerbet alcohols, 24-26, branched and cyclic was conducted with zebra fish (Danio rerio) over a 28-d exposure period at a concentration of 100 mg/l. The test was performed under semi-static conditions and test solutions were renewed daily. During the 28-day exposure period, no deaths and visible toxic signs were observed in the control and the test group. At the start and the end, the fish were weighd individually as wet weights (blotted dry). The pseudo-specific growth rate "r3" was calculated to evaluate toxic effetcs. Two-sided Student t-test with a 5% significance level was used to compare "r3" of the test group with the control and to obtain the lowest observed effect loading rate (LOEL) and the no observed effect loading rate (NOEL). The result of the two-sided Student t-test indicated that r3 did not display significant differences (p> 0 .05) between the control and the test group.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L