Registration Dossier

Ecotoxicological information

Long-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
adult fish: sub(lethal) effects
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Remarks:
Only secondary literature available (SIDS documents; Iuclid reference [10]; Reliability assigned: 1)
Qualifier:
according to
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
yes
Test organisms (species):
Oryzias latipes
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
14 d
Duration:
14 d
Dose descriptor:
LC50
Effect conc.:
> 17 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
14 d
Dose descriptor:
NOEC
Effect conc.:
1.28 mg/L
Conc. based on:
test mat.
Basis for effect:
behaviour

Nominal/measured Concentration:

Measured concentration (mg/L)       (percentage of nominal)

Nominal

concentration

(mg/L)

0-day

7-day

14-day

Mean*

control

n.d.

n.d.

n.d

n.d.

Solvent control

n.d.

n.d.

n.d.

n.d.

0.512

0.499

(97.6)

0.449

(87.7)

0.480

(93.8)

0.476

(93.0)

1.28

1.25

(97.6)

1.10

(85.7)

1.23

(96.2)

1.19

(93.1)

3.20

3.09

(96.6)

2.59

(80.8)

2.87

(89.8)

2.85

(89.1)

8.00

7.80

(97.5)

7.02

(87.8)

7.31

(91.4)

7.32

(92.2)

20.0

17.6

(88.2)

16.7

(83.6)

17.1

(85.4)

17.1

(85.7)

* Expressed as arithmetic means calculated

Water Temperature: 23.9 - 24.3 degree C

Water Chemistry in test: pH 6.9-7.5; Dissolved oxygen = 7.6-8.3 mg/L(oxygen saturation level>=60%)

Mortality:

Cumulative mortality:

cumulative number of dead fish

mortality (%) vs time (day)

Nominal

concentration

(mg/L)

1

2

3

4

5

6

7

8

9

10

11

12

13

14

control

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

Solvent control

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0.512

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

1.28

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

3.20

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

8.00

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

20.0

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

0

(0)

1

(10)

1

(10)

1

(10)

LC50, Exposure time 7days:       > 20mg/L

LC50, Exposure time 14days:    > 20mg/L

Other effects : Toxic symptoms

Toxic symptoms, on day

Nominal

concentration

(mg/L)

1

2

3

4

5

6

7

8

9

10

11

12

13

14

control

-

-

-

-

-

-

-

-

-

-

-

-

-

-

Solvent control

-

-

-

-

-

-

-

-

-

-

-

-

-

-

0.512

-

-

-

-

-

-

-

-

-

-

-

-

-

-

1.28

-

-

-

-

-

-

-

-

-

-

-

-

-

-

3.20   AB

-

-

1

-

-

-

-

-

-

-

-

-

-

-

3.20 RFA

-

5

3

-

-

-

-

-

-

-

-

-

-

-

8.00   AB

2

2

10

8

5

5

5

5

5

5

4

2

-

-

8.00   RFA

10

10

10

10

10

10

10

10

10

10

10

10

10

10

20.0   AB

10

10

10

10

10

10

10

10

10

10

10

9

9

9

20.0   RFA

10

10

10

10

10

10

10

10

10

10

10

9

9

9

20.0   LT

-

-

-

4

3

3

3

The values express the number of fish showing the symptoms:

AB : Abnormal behavior; RFA: Reduced feeding activity; LT : Light body color; - : no symptom

Effect levels:

-NOEC(14 d):              1.28 mg/L

-EC50 (behavior):        3.20 (2.17-4.72) mg/L

Validity criteria fulfilled:
yes
Conclusions:
Key results in a 14-day fish toxicity test were as follows:
- the LC50 (14d) was > 20 mg/L
- behavioral changes were seen in approx. 50% of the fish at nominal 8 mg/L, during days 1 through day 14
- Effect levels:
-NOEC(14 d):              1.28 mg/L
-EC50 (behavior):        3.20 (2.17-4.72) mg/L
Executive summary:

3,5,5,-trimethylhexan-1 -ol was examined in a 14-day fish toxicity test according to OECD TG 204 and GLP. The nominal concentration ranged from 0.512 to 20 mg/L (measured approx. 0.475 - 17.1 mg/L). The key results were as follows:

- the LC50 (14d) was > 20 mg/L (nominal)

- behavioral changes were seen in approx. 50% of the fish at nominal 8 mg/L (measured mean 7.36 mg/L) during days 1 through day 14, and in all fish at nominal 20 mg/L

Effect levels:

- NOEC(14 d):               1.28 mg/L

- EC50 (behavior):        3.20 (2.17-4.72) mg/L

- LC50 (14d) > 20 mg/L

(source: CITI, 1997).

Description of key information

3,5,5,-trimethylhexan-1-ol was examined in a 14-day fish toxicity test according to OECD TG 204 and GLP. The NOEC value was 1.28 mg/L.

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater fish:
1.28 mg/L

Additional information