Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Short-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Remarks:
The concentration and stability of the test item in the test preparations was verified by chemical analysis at 0, 24, 72 and 96 hours.
Details on sampling:
- Concentrations: Nominal concentrations of 10, 18, 32, 56 and 100 % v/v.
Vehicle:
no
Test organisms (species):
not specified
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
No additional post exposure period implemented in test design.
Salinity:
Not relevant for freshwater study
Nominal and measured concentrations:
The concentration and stability of the test item in the test preparations was verified by chemical analysis at 0, 24, 72 and 96 hours.
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
6.7 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: 95% confidence limits: 6.0 to 7.4 µg/L
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
6 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
7.4 µg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Mortality of control: No lethal or sub-lethal effects were observed in any control fish.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: There was a small amount of test item measured in the control sample at the 72 hours (fresh). This is considered to have been post sampling contamination as the 96 hour (old) sample had results of less that the limit of quantification. Therefore considered not to have impacted the outcome of the study. No sub lethal effects were observed in any control fish.
- Effect concentrations exceeding solubility of substance in test medium: Not applicable.
Sublethal observations / clinical signs:

  Table 1: Cumulative mortality for the different concentration levels of the test compound:

Nominal

Concentration

(% v/v)

Cumulative Mortality (Initial Population = 7)

%

Mortality

1
Hour

3
Hours

6
Hours

24 Hours

48 Hours

72 Hours

96 Hours

96
Hours

Control

0

0

0

0

0

0

0

0

10

0

0

0

0

0

0

0

0

18

0

0

0

0

0

0

0

0

32

0

0

0

0

0

0

0

0

56

0

0

0

0

0

0

0

0

100

0

0

0

0

0

7

7

100

 

  

Table 2: Analytical result:

Concentration

(% v/v) Sat Sol

0 hours

24 hours old

72 hours fresh

96 hours old

Measured
Concentration

(mg/L)

Measured
Concentration

(mg/L)

Measured
Concentration (mg/l)

Measured
Concentration

(mg/L)

Control

<LOQ

<LOQ

0.00161

<LOQ

10

0.000972

0.000432

0.00223

0.000931

18

0.00186

0.000897

0.00316

0.00178

32

0.00355

0.00172

0.00614

0.00329

56

0.00628

0.00324

0.0101

0.00552

100

0.0123

0.00442

-

-

LOQ = 0.00030 mg/L

 

Table 3: Effect concentrations of the acute fish toxicity study.

(Hours)

LC50
(µg/L)

95% Confidence Limits
(µg/L)

NOEC
(µg/L)

LOEC
(µg/L)

96

6.7

6.0

-

7.4

6.0

7.4

 

 

 

 

 

 

 

 

Validity criteria fulfilled:
yes
Conclusions:
Acute toxicity of the test compound to freshwater fish was tested according to OECD Guideline 203.
Following results have been obtained after an exposure period of 96 hours: LC50 = 6.7 µg/L (95% confidence limits: 6.0 to 7.4 µg/L), NOEC = 6.0 µg/L, LOEC = 7.4 µg/L.
Executive summary:

Acute toxicity of the test compound to freshwater fish was tested according to OECD Guideline 203 and GLP. Nominal concentrations of 10, 18, 32, 56 and 100 % v/v have been investigated.

The concentration and stability of the test item in the test preparations was verified by chemical analysis at 0, 24, 72 and 96 hours.

At the highest nominal concentration level of 100 % v/v, measured test compound concentration was 12.3 µg/L (0 hours, i.e. at test begin) and 4.42 µg/L (after 24 hours), respectively. LOC was 0.30 µg/L.

Following results have been obtained after an exposure period of 96 hours: LC50 = 6.7 µg/L (95% confidence limits: 6.0 to 7.4 µg/L), NOEC = 6.0 µg/L, LOEC = 7.4 µg/L.

Time Point
(Hours)

LC50
(µg/L)

95% Confidence Limits
(µg/L)

NOEC
(µg/L)

LOEC
(µg/L)

96

6.7

6.0

-

7.4

6.0

7.4

 

 

 

 

 

 

 

 

Description of key information

OECD 203, GLP, LC50 (96 h) = 0.0067 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
0.007 mg/L

Additional information

Acute toxicity of the compound reaction mass of m-terphenyl and o-terphenyl was investigatedaccording to OECD Guideline 203.

Following results have been obtained after an exposure period of 96 hours: LC50 = 6.7 µg/L (95% confidence limits: 6.0 to 7.4 µg/L), NOEC = 6.0 µg/L, LOEC = 7.4 µg/L.