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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
9-14 June 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
according to guideline
Guideline:
other: DIN 38412 L15 (DEV-11. Lieferung 1982)
Principles of method if other than guideline:
Method: other: Bestimmung der Wirkung von Wasserinhaltsstoffen auf Fische, DIN 38412 Teil15
GLP compliance:
yes
Vehicle:
no
Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Goldorfe
- Source: commercial hatchery P.Eggers, Hohenwestedt, Germany
- Length at study initiation (length definition, mean, range and SD): 4.9-5.5cm
- Weight at study initiation (mean and range, SD): 1.0-1.4g

ACCLIMATION
- Acclimation period: 11days
- Acclimation conditions (same as test or not):same

Limit test:
yes
Total exposure duration:
48 h
Test temperature:
19-21°C
pH:
6.9-7.8
Dissolved oxygen:
>7.0mg/L
Nominal and measured concentrations:
nominal concentrations: 3200, 1800, 1000, 560, 320, 100, 0 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: all-glass aquaria, 12L, 10L
- Aeration: slightly
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates):
- No. of vessels per control (replicates):


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic dilution water according to DEV L15



OTHER TEST CONDITIONS
- Photoperiod: 12hours light, 12 hours dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mortality observed after 24 and 48hours of the test

Reference substance (positive control):
not specified
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
1 758 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC100
Effect conc.:
3 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
1 872 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: swimming behaviour
Sublethal observations / clinical signs:

Numbers of surviving fishes and their condition at several concentrations of Guanidine Nitrate and after several exposure times: 

time (h)

concentration of Guanidine Nitrate (mg/L)

 

0

100

180

320

560

1000

1800

3200

0

10

10

10

10

10

10

10

10

24

10

10

10

10

10

10

10

0

48

10A

10B

10B

10B

10B

10B

3D

0

ACondition of all fishes, visually assessed, normal (=good)

BCondition of all fishes, visually assessed, equal to that of the control fishes

CCondition (swimming behaviour) of the quoted number of fishes, visually assessed, poorer than that of the control fishes, the condition of 7 fishes was about equal to that of the control fishes, but the conditions of the other 3 fishes was very poor, these 3 fishes reacted very slowly and swam upside-down.

D condition (swimming behavior) of the quoted number of fishes, isually assessed, was very poor, the reacted very slowly and swam upside down.

Conclusions:
In contrast to OECD Guideline 203 and the recommendation in REACH Guideline R.7.b, the test duration was only 48hours.
The 48-h LC50 was 1758 mg a.i./L.  The 48-h-NOEC value, based on mortality, was 1000 mg a.i./L.  Sublethal effects of swimming behaviour were observed in the groups exposed to 1000 and 560mg a.i./L of Guanidine Chloride.  
Executive summary:

In a 48-h acute toxicity study, Leuciscus idus (‘Goldorfe’) were exposed to Guanidine Chloride at nominal concentrations of 0 (control), 100, 320, 560, 1000, 1800, 3200 mg a.i./L.  The 48-h LC50was 1758 mg a.i./L.  The 48-h-NOEC value, based on mortality, was 1000 mg a.i./L.  Sublethal effects of swimming behaviour were observed in the groups exposed to 560 and 1000mg a.i./L of Guanidine Chloride.  

This toxicity study is classified as acceptable and satisfies the guideline requirement for toxicity study with the exeption of a shorter duration of the test as recommended by the OECD Guideline 203.

 

Results Synopsis

 

Test organism size: 5.2±0.3cm length, 1.2±0.2g weight

Test Type: Static

 48-h-LC50:  1758 mg a.i./L                        

48-h-NOEL1000 mg a.i./L                            

Endpoint(s) Effected: letallity

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline available
Principles of method if other than guideline:
Guideline not cited
GLP compliance:
not specified
Test organisms (species):
other: Ictalurus punctatus, Pimephales promelas
Details on test organisms:
1.test: Ictalurus punctatus (Channel catfish)
2.test: Pimephales promelas (Fathead minnow)
Test type:
flow-through
Water media type:
not specified
Total exposure duration:
96 h
Test temperature:
20-22°C
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
1 850 mg/L
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Ictalurus punctatus
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
690 mg/L
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Remarks on result:
other: Pimephales promelas
Details on results:
results of the first test tested in Ictalurus punctatus
results of the second test in Pimephales promelas
Sublethal observations / clinical signs:

information cited from

Rohr. J.M. 1984. Guanidine Nitrate Toxicity Study. Wilson Laboratories, Salina, KS

Validity criteria fulfilled:
not specified
Conclusions:
The 96h acute toxicity of Guanidine Nitrate to fish was determined in two different species: in Ictalurus punctatus (Channel catfish) and Pimephales promelas (Fathead minnow). When testing Ictalurus punctatus a 96-h-LC50 of 1850mg/L was determined. In contrast, for Pimephales promelas a 96-h-LC50 of 690mg/L was determined.
Executive summary:

In a 96-h acute toxicity study, Ictalurus punctatus (Channel catfish) and Pimephales promelas (Fathead minnow) were exposed to Guanidine Nitrate under flow through conditions.  The 96-h LC50in Ictalurus punctatus was1850 mg a.i./L, the 96-h LC50in Pimephales promelas was 690 mg a.i./L.  

Results Synopsis

 Test Type: Flowthrough

Ictalurus punctatus:

 LC50:  1850 mg a.i./L   

Pimephales promelas:     

 LC50:   690 mg a.i./L        95% C.I.:  535 to 890 mg a.i./L

Endpoint(s) Effected: short-term toxicity to fish

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
6-10 June 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Qualifier:
according to guideline
Guideline:
other: DIN 38412 L15 (DEV-11. Lieferung 1982)
Principles of method if other than guideline:
Method: other: Bestimmung der Wirkung von Wasserinhaltsstoffen auf Fische, DIN 38412 Teil15
GLP compliance:
yes
Vehicle:
no
Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Goldorfe
- Source: commercial hatchery P.Eggers, Hohenwestedt, Germany
- Length at study initiation (length definition, mean, range and SD): 4.9-5.5cm
- Weight at study initiation (mean and range, SD): 1.0-1.4g

ACCLIMATION
- Acclimation period: 11days
- Acclimation conditions (same as test or not):same

Limit test:
yes
Total exposure duration:
48 h
Test temperature:
19-21°C
pH:
7.1-7.7
Dissolved oxygen:
>7.0mg/L
Nominal and measured concentrations:
nominal concentrations: 3200, 1800, 1000, 560, 320, 100, 0 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: all-glass aquaria, 12L, 10L
- Aeration: slightly
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates):
- No. of vessels per control (replicates):


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic dilution water according to DEV L15



OTHER TEST CONDITIONS
- Photoperiod: 12hours light, 12 hours dark


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mortality observed after 24 and 48hours of the test

Reference substance (positive control):
not specified
Key result
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
1 800 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
2 420 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC100
Effect conc.:
3 200 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
2 420 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: swimming behaviour
Sublethal observations / clinical signs:

Numbers of surviving fishes and their condition at several concentrations of Guanidine Nitrate and after several exposure times: 

time (h)

concentration of Guanidine Nitrate (mg/L)

 

0

100

180

320

560

1000

1800

3200

0

10

10

10

10

10

10

10

10

24

10

10

10

10

10

10

10

0

48

10A

10B

10B

10B

10B

10B

10C

0

ACondition of all fishes, visually assessed, normal (=good)

BCondition of all fishes, visually assessed, equal to that of the control fishes

CCondition (swimming behaviour) of the quoted number of fishes, visually assessed, poorer than that of the control fishes, the condition of 7 fishes was about equal to that of the control fishes, but the conditions of the other 3 fishes was very poor, these 3 fishes reacted very slowly and swam upside-down.

Conclusions:
In contrast to OECD Guideline 203 and the recommendation in REACH Guideline R.7.b, the test duration was only 48hours.
The 48-h LC50was 2420 mg a.i./L.  The 48-h-NOEC value, based on mortality, was 1800 mg a.i./L.  Sublethal effects of swimming behaviour were observed in the groups exposed to 1800 and 3200mg a.i./L of Guanidine Nitrate.  
Executive summary:

In a 48-h acute toxicity study, Leuciscus idus (‘Goldorfe’) were exposed to Guanidine Nitrate at nominal concentrations of 0 (control), 100, 320, 560, 1000, 1800, 3200 mg a.i./L.  The 48-h LC50was 2420 mg a.i./L.  The 48-h-NOEC value, based on mortality, was 1800 mg a.i./L.  Sublethal effects of swimming behaviour were observed in the groups exposed to 1800 and 3200mg a.i./L of Guanidine Nitrate.  

This toxicity study is classified as acceptable and satisfies the guideline requirement for toxicity study with the exeption of a shorter duration of the test as recommended by the OECD Guideline 203.

 

Results Synopsis

 

Test organism size: 5.2±0.3cm length, 1.2±0.2g weight

Test Type: Static

 

48-h-LC50:  2420 mg a.i./L                        

48-h-NOEL1800 mg a.i./L                            

Endpoint(s) Effected: lethallity

Description of key information

The acute toxicity of the read-across substance Guanidine Nitrate was tested in a 96-h toxicity test against

Ictalurus punctatus (Channel catfish), Pimephales promelas (Fathead minnow) and Leuciscus idus (Goldorfe). The 96-h-LC50 was reported as 690 mg a.i./L in the toxicity test against Pimerphales promelas.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
690 mg/L

Additional information

The acute toxicity of Guanidine Chloride was teste with Leuciscus idus according to DIN 28412 L15 for 48h. The 48h-LC50 was determined to be 1,758 mg/l a.i. As the test duration was less than 96h, instead the result from the 96h -test with the read-across substance Guanidine nitrate was used.

The acute toxicity of the read-across substance Guanidine Nitrate was tested in toxicity tests against Ictalurus punctatus (Channel catfish), Pimephales promelas (Fathead minnow) peer-reviewed by van der Schalie (1985) and Leuciscus idus (Goldorfe) reported by Adema (1988).

In contrast to OECD Guideline 203 and the recommendation in REACH Guideline R.7.b, the test duration was only 48hours in the study of Adema (1988). Nethertheless both studies together are significant. In the study of Adema (1988) a 48-h-LC50 of 2420mg a.i.mg/L was reported whereas in the study of van der Schalie (1989) two results of Rohr (1984) were peer-reiewed with an 96 -h-LC50 of 690 mg/L when testing Pimephales promelas and an 96 -h-LC50 of 1850mg/L when testing Ictalurus punctatus.

Justification for read-across:

Guanidine hydrochloride and guanidine nitrate dissociate in aqueous media to yield the guanidine ion and the respective anion. Therefore it is reasonable to discuss the effects of the ions separately. The chloride ion is a naturally occurring essential ion in human beings with well-known metabolism and mechanisms of action as described in standard textbooks on pharmacology and physiology. As well it is found as salt in the Earth´s crust and is dissolved in seawater. Effects of guanidine hydrochloride are expected to be based primarily on the guanidine ion. The physiological processing of the guanidine ion is expected to be independent of the individual source. Therefore read-across from guanidine nitrate for effects of guanidine dissociated from guanidine hydrochloride is considered valid. This strategy is supported by a quite similar toxicological profile of both substances, as shown in acute toxicity, irritation, sensitization and genotoxic studies.

A more detailed justification for read-across is attached in IUCLID chapter 13.