Cetrimonium chloride

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From January 28, 1985 to April 10, 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No analytical dose verification.

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Strain: Hamilton-Buchanan
- Source: Hoechst AG own culture
- Length at study initiation (length definition, mean, range and SD): 2.5 - 3.5 cm

ACCLIMATION
- Acclimation period: min. 12 days
- Acclimation conditions (same as test or not): yes
- Feeding frequency: twice a day ad libitum
- Feed type: Tetra Min, Tetra Werke, Melle, Germany

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

21.1 - 22.8°C

pH:

7.3 - 8.1

Dissolved oxygen:

6.3 - 9.0 mg/L

Nominal and measured concentrations:

Nominal: 0, 0.1, 0.35, 0.5, 0.71, 1.0, 10, 100 and 500 mg/L
Equivalent to: 0, 0.03, 0.10, 0.15, 0.21, 0.29, 2.9, 29 and 145 mg/L based on active ingredient.

Details on test conditions:

TEST SYSTEM
- Test vessel: 10 L glass vessels
- No. of organisms per vessel: 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water according to ISO/DIS 7346/1

OTHER
- 12:12 light dark cycle
- 700 Lux lamp

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

ca. 0.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: equivalent to 0.15 mg a.i./L

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

ca. 0.71 - ca. 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: equivalent to 0.19-0.29 mg a.i./L

Key result

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

ca. 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: equivalent to 0.29 mg a.i./L

Details on results:

For result tables, kindly refer to the attached background material section of the IUCLID.

Sublethal observations / clinical signs:

The following symptoms were seen at 100 and 500 mg/L: swimming on the surface, quick panicked swimming, fleeing reactions, loss of balance, back or side position, stocky breathing. From 0.71 to 10 mg/L, tail swimming, hypoactivity, open gill cover and fast breathing. Moribund fish in this group had a lighter body color and reddened gills. Two fish showed transient tail swimming at 0.5 mg/L. The fish at 0.1 and 0.35 mg/L were symptom-free.

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 96 h LC50 was determined to be 0.71 - 1.0 mg/L (i.e., equivalent to 0.21 - 0.29 mg a.i./L).

Executive summary:

A study was conducted to determine the acute toxicity of test substance, C16 TMAC (29% active in water) to zebra fish (Brachydanio rerio) according to OECD Guideline 203 and EU Method C1, in compliance with GLP. Ten fish per group were exposed to the test substance at nominal concentrations of 0, 0.1, 0.35, 0.5, 0.71, 1.0, 10, 100 and 500 mg/L (i.e. 0, 0.03, 0.10, 0.15, 0.21, 0.29, 2.9, 29 and 145 mg a.i./L) for 96 h and under static conditions. No analytical verification of the test concentrations were performed. Mortality and clinical signs were recorded. Effects were observed at 0.5 mg/L and above. The 96 h LC0, LC50 and LC100 values were determined to be 0.5 mg/L (0.15 mg a.i./L); 0.71 - 1.0 mg/L (0.21 -0.29 mg a.i./L) and 1 mg/L (0.29 mg a.i./L), respectively. Under the study conditions, the 96 h LC50 was determined to be 0.71 - 1.0 mg/L (i.e., equivalent to 0.21 - 0.29 mg a.i./L) (Markert and Weigand, 1985).

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From January 01, 1990 to April 20, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No analytical dose verification.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Zoo Stumpe Hildesheim
- Body length: ca. 3.2 cm
- Bodyweight: ca. 0.42 g

ACCLIMATION
- Feed type: Tetra feed

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

20 - 21°C

pH:

7.9 - 8.3

Dissolved oxygen:

7.7 - 8.5 mg/L

Nominal and measured concentrations:

Nominal: 0, 0.1, 0.25, 0.5, 1.0, 2.5, 5.0 and 10.0 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 16 L glass vessels
- No. of organisms per vessel: 10

OTHER
- 12:12 light dark cycle

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

ca. 0.25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: equivalent to 0.125 mg a.i./L

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

ca. 0.59 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: equivalent to 0.295 mg a.i./L

Key result

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

ca. 1 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: equivalent to 0.50 mg a.i./L

Details on results:

For result tables, kindly refer to the attached background material section of the IUCLID.

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 96 h LC50 was determined to be 0.59 mg/L (equivalent to 0.295 mg a.i./L).

Executive summary:

A study was conducted to determine the toxicity of test substance, C16 TMAC (50% active in hydroalcoholic solution) to zebra fish (Brachydanio rerio) according to OECD Guideline 203 and EU Method C1, in compliance with GLP. Ten fish per group were exposed to the test substance at nominal concentrations of 0, 0.1, 0.25, 0.5, 1.0, 2.5, 5.0 and 10.0 mg/L for 96 h and under static conditions. No analytical verification of the test concentrations were performed. Mortality was observed at 0.5 mg/L and above. The 96 h LC₀, LC₅₀ and LC₁₀₀ were observed to be 0.25 , 0.59 and 1.0 mg/L, respectively (equivalent to 0.125, 0.295 and 0.50 mg a.i./L). Under the study conditions, the 96 h LC50 was determined to be 0.59 mg/L (equivalent to 0.295 mg a.i./L) (Noack, 1990).

Description of key information

Based on the available study results, the lower limit of 96 h LC50 value of 0.21 mg a.i./L (nominal) for freshwater fish has been considered further for hazard/risk assessment. 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

210 µg/L

Additional information

Study 1:

A study was conducted to determine the acute toxicity of test substance, C16 TMAC (29% active in water) to zebra fish (Brachydanio rerio) according to OECD Guideline 203 and EU Method C1, in compliance with GLP. Ten fish per group were exposed to the test substance at nominal concentrations of 0, 0.1, 0.35, 0.5, 0.71, 1.0, 10, 100 and 500 mg/L (i.e. 0, 0.03, 0.10, 0.15, 0.21, 0.29, 2.9, 29 and 145 mg a.i./L) for 96 h and under static conditions. No analytical verification of the test concentrations were performed. Mortality and clinical signs were recorded. Effects were observed at 0.5 mg/L and above. The 96 h LC0, LC50 and LC100 values were determined to be 0.5 mg/L (0.15 mg a.i./L); 0.71 - 1.0 mg/L (0.21 -0.29 mg a.i./L) and 1 mg/L (0.29 mg a.i./L), respectively. Under the study conditions, the 96 h LC50 was determined to be between 0.71 - 1.0 mg/L (i.e., equivalent to 0.21 - 0.29 mg a.i./L) (Markert and Weigand, 1985).

Study 2:

A study was conducted to determine the toxicity of test substance, C16 TMAC (50% active in hydroalcoholic solution) to zebra fish (Brachydanio rerio) according to OECD Guideline 203 and EU Method C1, in compliance with GLP. Ten fish per group were exposed to the test substance at nominal concentrations of 0, 0.1, 0.25, 0.5, 1.0, 2.5, 5.0 and 10.0 mg/L for 96 h and under static conditions. Mortality was recorded. No analytical verification of the test concentrations were performed. Mortality was observed at 0.5 mg/L and above. The 96 h LC0, LC50 and LC100 were observed to be 0.25 , 0.59 and 1.0 mg/L, respectively(equivalent to 0.125, 0.295 and 0.50 mg a.i./L). Under the study conditions, the 96 h LC50 was determined to be 0.59 mg/L (equivalent to 0.295 mg a.i./L) (Noack, 1990).

Based on the available study results, the lower limit of 96 h LC50 value of 0.2 mg a.i./L (nominal) for freshwater fish has been considered further for hazard/risk assessment.