REAKTIV-GELB F-68 072 FW

Short-term toxicity to fish

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:

19 April 1993 to 23 April 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted to EU & OECD test guidance in compliance with GLP.

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

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable.

Analytical monitoring:

yes

Details on sampling:

In order to determine the substance concentration, water samples were taken from the middle of the test chamber of each first and third preparation of the test after 0 and 24 hours. All values determined were in a range of + 20 % of the theoretical value.

Vehicle:

no

Details on test solutions:

Reconstituted water, composition according to ISO/DIS 7346/1 was used as water for dilution.
Preparation was carried out in a unit consisting of two Hostalen- lined steel vessels with a capacity of 1700 litres each.
The prepared dilution water was aerated until oxygen saturation. The pH was measured before the use of the study batch and was 8.0 - 8.3.

The test substance was weighed in a beaker. Water for dilution was added and the mixture homogenized using an Ultra-Turrax and Ultrasonic Bath and poured into the chamber under stirring with a glass rod. The chamber contents were then stirred for approximately 30 minutes with a KPG-stirrer and a glass rod. All tested concentrations were present as orange solution.

After adding the substance the pH-value was adjusted to pH 7 to maintain a stable solution over 96 h.

In order to determine the substance concentration, water samples were taken from the middle of the test chamber by pipetting approx. 20 ml into a screw-neck glass bottle of each first and third preparation of the test after 0 and 24 hours.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

Species: zebra fish
Brachydanio rerio (HAMILTON-BUCHANAN)
Breeding station: Central Toxicology (Hoechst AG)
Date of hatching: 03/01/1992
Delivery date: 10/27/1992

The fish were kept for at least 14 days before the start of the study in water for dilution (see section 4.4) under the following conditions:

Temperature: 22 ± 1 °C
Oxygen content: > 80 % of the saturation value
Duration of lighted period: 12 hours daily
Population density: < 1 g fish/1 water
Feeding: twice daily ad 1ibitum
Feed: Tetra Standard Mix, Tetra Werke, Melle (FRG)

The body length of 7 representative fish from the batch was measured.
Body length (cm)
Batch no. Date n Variation range x s
2/92/H2/L20 4/23/93 7 3.2 - 3.5 3.3 0.12

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

No post exposure observation period

Hardness:

No data

Test temperature:

21.3 - 22.8 C

pH:

7.0 - 7.9

Dissolved oxygen:

7.0 - 9.5 mg/l

Salinity:

Not applicable.

Nominal and measured concentrations:

0, 100 mg/l

Details on test conditions:

Study groups
There were 7 fish in each group. As a result of the dose-finding studies the following concentration was tested:
Start of study Test chamber No. Concentration (mg/l)
04/19/93 3 / 4 0 / 100

Water for dilution
Reconstituted water, composition according to ISO/DIS 7346/1 was used as water for dilution.
Preparation was carried out in a unit consisting of two Hostalen- lined steel vessels with a capacity of 1700 litres each.
The prepared dilution water was aerated until oxygen saturation. The pH was measured before the use of the study batch and was 8.0 - 8.3.

Test conditions
The study was conducted in a semistatic system. The fish were transferred to new test chambers every 24 hours. The test chambers, which were calibrated to 10 liters, were made of glass (length 30 cm, width 22 cm, height 24 cm) and stood in a water bath made of Hostalit ZR with a Plexiglas viewing panel. The temperature of the water bath was regulated by a thermostat to 22 + 1 °C. The chambers were illuminated from above from 6.00 a.m. to 6.00 p.m. The light intensity directly over the chambers was approximately 700 lux.

The test chambers were not aerated during the course of the study.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

Lethality
In this 96-hour acute toxicity study of Reaktiv-Gelb F-68 072 FW in zebra fish (Brachydanio rerio) no lethality occurred in the 100 mg/L-group.
Appearance and behaviour
The fish showed changes in appearance and behaviour, swimming behaviour and respiration rate.

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

Not reported.

Sublethal observations / clinical signs:

Symptoms – individual values

 

0 mg/l (control groups of all study parts)

Time after study start	1^stday		2^ndday		3^rdday		4^thday		5^thday
Time after fish insertion (h)	3	6	24	3-6	24	3-6	24	3-6	24
Lethality (absolute)	0/7	0/7	0/7	0/7	0/7	0/7	0/7	0/7	0/7
No changes in appearance and behaviour	7/7	7/7	7/7	7/7	7/7	7/7	7/7	7/7	7/7

 

100 mg/l

Time after study start	1^stday		2^ndday		3^rdday		4^thday		5^thday
Time after substance addition (h)	3	6	24	3-6	24	3-6	24	3-6	24
Lethality (absolute)	0/7	0/7	0/7	0/7	0/7	0/7	0/7	0/7	0/7
No changes in appearance and behaviour	-	-	-	-	-	a	a	a	a
Hyperactivity	s	s	-	-	-	-	-	-	-
Swimming posture tail heavy	s	s	s	s	s	-	-	-	-
Increased fright reaction	-	s	-	-	-	-	-	-	-
Irregular respiration	-	s	-	-	-	-	-	-	-
Projecting opercula	-	-	s	s	s	-	-	-	-

 

s = some fish

a = all fish

Validity criteria fulfilled:

yes

Conclusions:

The LC50 after 96 hours exceeds 100 mg/L.

Executive summary:

The acute toxicity of Reaktiv-Gelb F-68 072 FW to fish was determined in compliance with the requirements of EEC-Guideline Guideline 79/831/EWG Appendix V Methods for the determination of ecotoxicity C.1. Acute toxicity on fish and the OECD-Guideline for testing of chemicals, 203 Fish, Acute Toxicity Test. Study conducted in compliance with the Principles of Good Laboratory Practice (GLP).

 

This 96-hour acute toxicity Study of Reaktiv-Gelb F-68 072 FW in zebra fish (Brachydanio rerio) was conducted in a semi static system, because in a static system the substance was not analytically detectable to a sufficient degree over 96 hours.

 

No lethality occurred at 100 mg/L. The LC50 after 48 and 96 hours therefore exceeds 100 mg/L.

 

After adding the substance the pH-value was adjusted to pH 7 to maintain a stable solution over 96 h.

 

The tested concentration was present as an orange solution.

 

In order to determine the substance concentration, water samples were taken from the middle of the test chamber of each first and third preparation of the test after 0 and 24 hours. All values determined were in a range of + 20 % of the theoretical value.

 

The 100 mg/1 group exhibited symptoms.The fish showed changes in appearance and behaviour, swimming behaviour and respiration rate.

 

The substance is not classified as harmful to fish.

Description of key information

The LC50 after 96 hours exceeds 100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Remarks:

(96 h)

Effect concentration:

> 100 mg/L

Additional information

The acute toxicity of Reaktiv-Gelb F-68 072 FW to fish was determined in compliance with the requirements of EEC-Guideline Guideline 79/831/EWG Appendix V Methods for the determination of ecotoxicity C.1. Acute toxicity on fish and the OECD-Guideline for testing of chemicals, 203 Fish, Acute Toxicity Test. Study conducted in compliance with the Principles of Good Laboratory Practice (GLP).

This 96-hour acute toxicity Study of Reaktiv-Gelb F-68 072 FW in zebra fish (Brachydanio rerio) was conducted in a semi static system, because in a static system the substance was not analytically detectable to a sufficient degree over 96 hours.

The tested concentration was present as an orange solution.

 

In order to determine the substance concentration, water samples were taken from the middle of the test chamber of each first and third preparation of the test after 0 and 24 hours. All values determined were in a range of + 20 % of the theoretical value.

 

The substance is not classified as harmful to fish.