Registration Dossier

Administrative data

Endpoint:
fish, juvenile growth test
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
Principles of method if other than guideline:
exposition time: 28 d
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test substance: Basisch Gelb 8511
- Batch No.: ZD 00969/086
- Analytical purity: 96.1 % (ZAX 97L00673)

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Forellenhof Fredelsloh, Moring 1, FRG
- Length at study initiation: 6.4 cm (5.8 - 7.0 cm)
- Weight at study initiation: 2.5 g (2.0 - 3.0 g)

FEEDING DURING TEST
- Food type: The animals received "Ssniff" trout starter "Kronen Fisch Aminostart 1 extr." of "Ssniff", Ferdinand-Gabriel-Weg 16, Soest, FRG:
- Amount and frequency: During the study about 4% of their mean body weight on workdays daily in 2 portions and on non-working days in one portion. Beginning with week 2 of the study the amount of feed was generally increased by 25% each week (calculated for the initial weight in each case and the number of survivors if applicable).

MEDICAL TREATMENT
- The fish were exposed twice 24 hours to 0 .05 mg/L malchite green chloride and
additionally 24 hours to 10 mg/L tetracycline hydrochloride during the first 10 days after
arrival at the testing facility.

Study design

Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d

Test conditions

Hardness:
2.27 - 2.41 mmol/L
Test temperature:
14 - 15 °C
pH:
8.0 - 8.3
Dissolved oxygen:
6.0 10.0 mg/L which is about 60 - 100 of max. saturation %
Nominal and measured concentrations:
Concentration of test substance: nominal (% analytical determinations):
Control (not quantifiable)
0.1 (not quantifiable)
0.316 (not quantifiable)
1.0 (not quantifiable)
2.15 ( 34.9 %)
4.64 (36.7 %)
10 (40.5 %)

Details on test conditions:
TEST SYSTEM
- Test vessel: glass aquaria (60 x 35 x 40 cm)
- Fill volume: 60 L
- Aeration: none
- Renewal rate of test solution (flow rate): 10 L / hour
- No. of organisms per test group: 20

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Drinking water from the city of Frankenthal, purified over charcoal and aerated
- The drinking water is regularly assayed for chemical contaminants by the municipal authorities of Frankenthal and the Technical Services of BASF AG as well as for presence of microbes by a contract laboratory.
- DOC: 2.4 mg/L

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light / 8 hours darkness

EFFECT PARAMETERS MEASURED:
- Body weight and length

Results and discussion

Effect concentrationsopen allclose all
Duration:
28 d
Dose descriptor:
other: NOAEC
Effect conc.:
0.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
length
Duration:
28 d
Dose descriptor:
other: NOAEC
Effect conc.:
0.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
weight
Duration:
28 d
Dose descriptor:
other: NOAEC
Effect conc.:
0.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: symptoms
Duration:
28 d
Dose descriptor:
other: NOAEC
Effect conc.:
0.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Any other information on results incl. tables

At the nominal concentrations 2.2 to 10 mg/L the analytical recoveries were below 80 %. At the nominal concentrations below 2.2 mg/L the analytical recoveries could not be determined. The deviations are presumely due to hydrolysis.

The effects seen in this study may be related to the test substance and its hydrolysis products, respectively.

OECD 204 is - in general - not relevant for assessing long term effects in fish. However, in the present study exposition time was 28 d and all validity criteria for OECD 215 (mortality in the controls, minimum increase of mean weight of fish in the controls within 28 d, minimum dissolved oxygen concentration throughout the test, maximum variation of water temperature between test chambers and maximum deviation of water temperature from the ranges specified for the test species) are fulfilled. Hence, the present study is considered relevant for assessing long term effects in fish.

Mortality:

The lowest concentration at which clear compound-related mortalities occurred was 0.316 mg/L (nominal concentration), where 19 from 20 test animals were dead after 28 d of exposition. The threshold level for compound-related mortalities was near 0.1 mg/L (nominal concentration), where 1 from 20 test animals was dead after 28 d of exposition. The "No Observed Adverse Effect Concentration (NOAEC)" for mortality determined by the study director was <= 0.1 mg/L (nominal concentration).

However, 1 dead test animal from 20 has to be considered within the normal biological variation. Hence, the corrected NOAEC for mortality is =0.1 mg/L (nominal concentration).

Toxic signs:

Orange discolorations of the ventral fins, the abdominal region and the nostrils and yellowish dicolorations of the head were observed. Discoloration was not considered to be an adverse effect. The threshold level for toxic signs (= symptoms) was greater than 0.1 and smaller than 0.316 mg/L (nominal concentration) . The "No Observed Adverse Effect Concentration (= NOAEC)" for toxic signs

(= symptoms) determined by the study director was =0.1 mg/L (nominal concentration).

Body weight and length (growth parameters):

Under the conditions of this study, the threshold level for the impairment of the growth

parameters body weight and length was > 0.1 mg/L (nominal concentration) .

The "No Observed Adverse Effect Concentration (NOAEC)" for the impairment of the

growth parameters body weight and length determined by the study director was 0.1 mg/L (nominal concentration).

Applicant's summary and conclusion