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Short-term toxicity to fish

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Reference
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:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
Data is from study report.
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
other: DIN 38 412 "Test procedure with water organisms (group l) general information for the planning, implementation and evaluation of biological test procedures (L1)" and "Determination of the effect of water ingredients on fish - fish test (L15)
Principles of method if other than guideline:
Short term toxicity to Leuciscus idus study was carried out for 96 hrs using Standard Operating Procedures (SOP) of the laboratory of fish toxicology. The study was performed according to DIN 38 412 "Test procedure with water organisms (group l) general information for the planning, implementation and evaluation of biological test procedures (L1)" and "Determination of the effect of water ingredients on fish - fish test (L15), respectively.
GLP compliance:
not specified
Test material information:
Composition 1
Specific details on test material used for the study:
- Name of test material : 4-amino-N-(4-aminophenyl)benzene-1-sulfonamide
- Common name: Diaminodiphenylsulfamid
- Solubility in water: slightly soluble
- Test substance no.: 87/135
- Molecular formula : C12H13N3O2S
- Molecular weight : 263.32 g/mol
- Smiles notation : O=S(=O)(c1ccc(cc1)Nc1ccc(cc1)N)N
- InChl : 1S/C12H13N3O2S/c13-9-1-3-10(4-2-9)15-11-5-7-12(8-6-11)18(14,16)17/h1-8,15H,13H2,(H2,14,16,17)
- Substance type : Organic
- Physical state : Solid
Analytical monitoring:
not specified
Details on sampling:
- Concentrations: Test chemical concentration used for the study were 250 and 500 mg/l, respectively.
- Sampling method: The product/test chemical was added to the test water without any pretreatment; subsequently the fish were placed into the aquaria.
Vehicle:
not specified
Test organisms (species):
Leuciscus idus
Details on test organisms:
TEST ORGANISM
- Common name: Golden Orfe
- Length at study initiation (length definition, mean, range and SD): 5.1 cm (ranges from 4.8 to 5.7 cm)
- Weight at study initiation (mean and range, SD): 1.8 gm (ranges from 1.4 to 2.7 gm)
- Housing: The fish were kept in a flow-through tank in tap water cleaned by active carbon and aerated with oil-free air.
- Duration of housing and adaptation: about 2 weeks

ACCLIMATION
- Acclimation period: about 2 weeks
- Type and amount of food during acclimation: Growth feed F/B 50, Ad libitum
- Adaptation to test water and test temperature: 3 days
Test type:
static
Water media type:
freshwater
Total exposure duration:
96 h
Hardness:
Total hardness: about 2.5 mmol/l
Test temperature:
20 ± 1°C
pH:
About 7.6
Dissolved oxygen:
Oxygen content: > 60% of maximum saturation
Nominal and measured concentrations:
Nominal concentrations: 250 and 500 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: All glass aquarium
- Material, size, headspace, fill volume: The size of the test vessel was 30 cm X 22 cm X 24 cm, volume 10 ml
- Aeration: Yes, slight aeration was given.
- No. of organisms per vessel: 10/conc.
- Biomass loading rate: 1.8 fish/l test water

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted freshwater according to Din 38 412, part 11, draft sept . 1981 preparation from fully demineralized tap water
Conductivity : max . 10 micro mho

The resalting is carried out by addition of
294.0 MG/L CaCl2 . 2 H20
123.3 MG/L MgSO4 . 7 H20
64.8 MG/L NaHC03
5.8 MG/L KCl

- Ca/mg ratio: 4:1
- Na/K ratio: 10:1
- Acid capacity: 0.8 mmol/l

OTHER TEST CONDITIONS
- Photoperiod: 16 hr light and 8 hr darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Determination of mortality and symptoms; Determination or calculation of the median lethal concentration (LC 50) and, if possible, the LC 5 and the LC 95 using the probit analysis* after hours (nominal conc .) : 1, 24, 48, 72, 96

TEST CONCENTRATIONS
- Range finding study: Yes, based on the results of a range finding study (lC 50 after 96 h : > 500 mg/l) and according to the highest concentration of 500 mg/l, nowadays generally accepted for acute studies using the din-method, and to be sure to obtain the NOEC, the concentrations were fixed as follows : 250 and 500 mg/l, respectively.
- Test concentrations: Test chemical concentration used for the study were 250 and 500 mg/l, respectively.
Reference substance (positive control):
yes
Remarks:
chloroacetamide was used as a positive control
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 500 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
No abnormalities were observed in any of the test animals after a period of 96 hrs.
No observable effect concentration: 500 mg/l
Maximum concentration causing no mortality: 500 mg/l
Minimum concentration causing 100$ mortality: > 500 mg/l
Reported statistics and error estimates:
Determination or calculation of the median lethal concentration (LC 50) and, if possible, the LC 5 and the LC 95 using the probit analysis* after hours (nominal conc .) : 1, 24, 48, 72, 96

Positive control of animals conducted with chloroacetamide LC50 after 48 h: about 32 mg/l. This lethal concentration corresponds to the normal sensitivity.

Mortality during the time of housing: about 0 .1%

Mortality during the adaptation period: 0%

Corpulence factor of the batch*: 1 .4

The corpulence factor K is calculated from the weight w(g) and the length l(cm) measured from the tip of the mouth to the end of the tail fin according to the formula k=100*w/l**3 .

Results

 

Nominal concentration (mg/l)

Number of fish

Dead fish after

1h

4h

24h

48h

72h

96h

250

500

0

10

10

10

0

0

0

 

0

0

0

0

0

0

0

0

0

0

0

0

 

Nominal concentration (mg/l)

Symptoms

1h

1h

1h

1h

1h

1h

250

500

0

 

No symptoms detectable

 

Explanation of Symptoms:

A = Apathy

E = Exophthalmos

H = Hyperreflexia

L = Gasping

T = Tumbling

V = Discoloration

X = Accelerated respiration

B = Abdominal distension

F = Escape reflex

K = Convulsions

N = Narcotic-like state

U = Restlessness

W = Headstand

Nominal concentration (mg/l)

pH

Beginning

4h

24h

48h

72h

96h

250

500

0

7.7

7.7

7.8

 

7.7

7.8

7.7

7.8

7.8

7.7

7.8

7.8

7.7

7.8

7.8

7.7

 

Nominal concentration (mg/l)

Oxygen content (mg/l)

Beginning

4h

24h

48h

72h

96h

250

500

0

8.8

8.8

8.5

 

8.3

8.4

7.9

8.3

8.6

7.6

8.4

8.5

8.0

8.7

8.7

8.1

 

Nominal concentration (mg/l)

Temperature (°C)

Beginning

4h

24h

48h

72h

96h

250

500

0

20

20

20

 

20

20

20

21

20

21

20

20

21

20

20

20

 

Nominal Concentrations

Fish Toxicity: After 1h

Concentration (mg/l)

Number of fish start

Dead fish after 1h

Mortality (%)

Concentration used

250

500

 

10

10

0

0

0.0

0.0

*

 

LC50 ˃ 500 (1% significance level)

 

Fish Toxicity: After 24h

Concentration (mg/l)

Number of fish start

Dead fish after 24h

Mortality (%)

Concentration used

250

500

 

10

10

0

0

0.0

0.0

*

 

LC50 ˃ 500 (1% significance level)

 

Fish Toxicity: After 48h

Concentration (mg/l)

Number of fish start

Dead fish after 48h

Mortality (%)

Concentration used

250

500

 

10

10

0

0

0.0

0.0

*

 

LC50 ˃ 500 (1% significance level)

 

Fish Toxicity: After 72h

Concentration (mg/l)

Number of fish start

Dead fish after 72h

Mortality (%)

Concentration used

250

500

 

10

10

0

0

0.0

0.0

*

 

LC50 ˃ 500 (1% significance level)

 

Fish Toxicity: After 96h

Concentration (mg/l)

Number of fish start

Dead fish after 96h

Mortality (%)

Concentration used

250

500

 

10

10

0

0

0.0

0.0

*

 

LC50 ˃ 500 (1% significance level)

 

Validity criteria fulfilled:
not specified
Conclusions:
No abnormalities were observed in any of the test animals after a period of 96 hrs and also no mortality was recorded. Thus, as no adverse effect were observed of the test chemical 4-amino-N-(4-aminophenyl)benzene-1-sulfonamide on the test organism Leuciscus idus, the NOEC and LC50 value was determined to be 500 and > 500 mg/l, respectively.
Executive summary:

Short term toxicity to Leuciscus idus study was carried out for 96 hrs using Standard Operating Procedures (SOP) of the laboratory of fish toxicology. The study was performed according to DIN 38 412 "Test procedure with water organisms (group l) general information for the planning, implementation and evaluation of biological test procedures (L1)" and "Determination of the effect of water ingredients on fish - fish test (L15), respectively.The study was based on the effects of the test compound4-amino-N-(4-aminophenyl)benzene-1-sulfonamide(CAS no. 16803-97-7) on Leuciscus idus (Golden Orfe) in a static fresh water system at a temperature of 20 ± 1°C, pH of about 7.6, Total hardness of 2.5 mmol/l and Oxygen content > 60% of maximum saturation with a photoperiod of 16 hr light and 8 hr darkness.Test chemical concentration used for the study were 250 and 500 mg/l, respectively. Chloroacetamide was used as a positive control. Leuciscus idus (Golden Orfe) of 5.1 cm in length (ranges from 4.8 to 5.7 cm), 1.8 gm in weight (ranges from 1.4 to 2.7 gm)was used as a test organism. The fish were kept in a flow-through tank in tap water cleaned by active carbon and aerated with oil-free air. The test organism was kept for housing and adapted was about 2 weeks and fed with growth feed F/B 50, Ad libitum. Test was performed in glass aquarium. The size of the test vessel was 30 cm X 22 cm X 24 cm and volume 10 ml. Test system was slightly aerated. No. of organisms used per conc. was 10 and biomass loading rate consists of 1.8 fish/l test water. Reconstituted freshwater water was used as a dilution water during the study. Determination of mortality and symptoms; Determination or calculation of the median lethal concentration (LC 50) and, if possible, the LC5 and the LC95 was calculated using the probit analysis after hours 1, 24, 48, 72 and 96, respectively. The 48 hr LC50 for the positive control chloroacetamide was determined to be 32 mg/l. No abnormalities were observed in any of the test animals after a period of 96 hrs and also no mortality was recorded. Thus, as no adverse effect were observed of the test chemical 4-amino-N-(4-aminophenyl)benzene-1-sulfonamide on the test organism Leuciscus idus, the NOEC and LC50 value was determined to be 500 and > 500 mg/l, respectively. Thus, based on the LC50 value, it can be concluded that the substance 4-amino-N-(4-aminophenyl)benzene-1-sulfonamide can be considered as non-toxic to aquatic organisms and thus can be considered to be not classified as per the CLP classification criteria.

Description of key information

Short term toxicity to Leuciscus idus study was carried out for 96 hrs using Standard Operating Procedures (SOP) of the laboratory of fish toxicology (Sustainability Support Services (Europe) AB, Report no. 10F0135/875091, 1987). The study was performed according to DIN 38 412 "Test procedure with water organisms (group l) general information for the planning, implementation and evaluation of biological test procedures (L1)" and "Determination of the effect of water ingredients on fish - fish test (L15), respectively. The study was based on the effects of the test compound4-amino-N-(4-aminophenyl)benzene-1-sulfonamide(CAS no. 16803-97-7) on Leuciscus idus (Golden Orfe) in a static fresh water system at a temperature of 20 ± 1°C, pH of about 7.6, Total hardness of 2.5 mmol/l and Oxygen content > 60% of maximum saturation with a photoperiod of 16 hr light and 8 hr darkness. Test chemical concentration used for the study were 250 and 500 mg/l, respectively. Chloroacetamide was used as a positive control. Leuciscus idus (Golden Orfe) of 5.1 cm in length (ranges from 4.8 to 5.7 cm), 1.8 gm in weight (ranges from 1.4 to 2.7 gm)was used as a test organism. The fish were kept in a flow-through tank in tap water cleaned by active carbon and aerated with oil-free air. The test organism was kept for housing and adapted was about 2 weeks and fed with growth feed F/B 50, Ad libitum. Test was performed in glass aquarium. The size of the test vessel was 30 cm X 22 cm X 24 cm and volume 10 ml. Test system was slightly aerated. No. of organisms used per conc. was 10 and biomass loading rate consists of 1.8 fish/l test water. Reconstituted freshwater water was used as a dilution water during the study. Determination of mortality and symptoms; Determination or calculation of the median lethal concentration (LC 50) and, if possible, the LC5 and the LC95 was calculated using the probit analysis after hours 1, 24, 48, 72 and 96, respectively. The 48 hr LC50 for the positive control chloroacetamide was determined to be 32 mg/l. No abnormalities were observed in any of the test animals after a period of 96 hrs and also no mortality was recorded. Thus, as no adverse effect were observed of the test chemical 4-amino-N-(4-aminophenyl)benzene-1-sulfonamide on the test organism Leuciscus idus, the NOEC and LC50 value was determined to be 500 and > 500 mg/l, respectively. Thus, based on the LC50 value, it can be concluded that the substance 4 -amino-N-(4 -aminophenyl)benzene-1 -sulfonamide can be considered as non-toxic to aquatic organisms and thus can be considered to be not classified as per the CLP classification criteria.

Key value for chemical safety assessment

LC50 for freshwater fish:
500 mg/L

Additional information

Short term toxicity to Leuciscus idus study was carried out for 96 hrs using Standard Operating Procedures (SOP) of the laboratory of fish toxicology (Sustainability Support Services (Europe) AB, Report no. 10F0135/875091, 1987). The study was performed according to DIN 38 412 "Test procedure with water organisms (group l) general information for the planning, implementation and evaluation of biological test procedures (L1)" and "Determination of the effect of water ingredients on fish - fish test (L15), respectively. The study was based on the effects of the test compound4-amino-N-(4-aminophenyl)benzene-1-sulfonamide(CAS no. 16803-97-7) on Leuciscus idus (Golden Orfe) in a static fresh water system at a temperature of 20 ± 1°C, pH of about 7.6, Total hardness of 2.5 mmol/l and Oxygen content > 60% of maximum saturation with a photoperiod of 16 hr light and 8 hr darkness. Test chemical concentration used for the study were 250 and 500 mg/l, respectively. Chloroacetamide was used as a positive control. Leuciscus idus (Golden Orfe) of 5.1 cm in length (ranges from 4.8 to 5.7 cm), 1.8 gm in weight (ranges from 1.4 to 2.7 gm)was used as a test organism. The fish were kept in a flow-through tank in tap water cleaned by active carbon and aerated with oil-free air. The test organism was kept for housing and adapted was about 2 weeks and fed with growth feed F/B 50, Ad libitum. Test was performed in glass aquarium. The size of the test vessel was 30 cm X 22 cm X 24 cm and volume 10 ml. Test system was slightly aerated. No. of organisms used per conc. was 10 and biomass loading rate consists of 1.8 fish/l test water. Reconstituted freshwater water was used as a dilution water during the study. Determination of mortality and symptoms; Determination or calculation of the median lethal concentration (LC 50) and, if possible, the LC5 and the LC95 was calculated using the probit analysis after hours 1, 24, 48, 72 and 96, respectively. The 48 hr LC50 for the positive control chloroacetamide was determined to be 32 mg/l. No abnormalities were observed in any of the test animals after a period of 96 hrs and also no mortality was recorded. Thus, as no adverse effect were observed of the test chemical 4-amino-N-(4-aminophenyl)benzene-1-sulfonamide on the test organism Leuciscus idus, the NOEC and LC50 value was determined to be 500 and > 500 mg/l, respectively. Thus, based on the LC50 value, it can be concluded that the substance 4 -amino-N-(4 -aminophenyl)benzene-1 -sulfonamide can be considered as non-toxic to aquatic organisms and thus can be considered to be not classified as per the CLP classification criteria.