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Long-term toxicity to fish

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Endpoint:
long-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
The influence on the egg-larval development of the fresh water fish Jordanella floridae was tested.
GLP compliance:
not specified
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Jordanella floridae
Details on test organisms:
METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS
- Subsequent handling of eggs: The test was started with eggs which were less than six hours old.

POST-HATCH FEEDING
- Type/source of feed: Nauplii of Artemia salina.
- Frequency of feeding: 3x/d during weekdays, 1x/d on Saturday and Sunday.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
35 d
Remarks on exposure duration:
7 d before and 28 d after hatching of the eggs
Post exposure observation period:
None
Hardness:
CaCO3 210 mg/L
Test temperature:
25 +- 1°C
pH:
7.9-8.6
Dissolved oxygen:
greater than 7.6 mg/L
Salinity:
Not applicable
Nominal and measured concentrations:
Nominal concentrations: 100, 180, 320, 560, 1000 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 1 L all-glass beakers, covered with a watch glass, fill volume: 1 L
- Aeration:
- Renewal rate of test solution: Test solutions were not renewed before the eggs had hatched (day 7). After hatching the test solutions were renewed every Monday, Wednesday and Friday.
- No. of fertilized eggs/embryos per vessel: 30
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic medium is prepared by addition of several salts to groundwater
- Chlorine: 2.72 mmol/L, Na 1.19 mmol/L, K 0.20 mmol/L, Ca 1.36 mmol/L, Mg 0.73 mmol/L, SO4 0.73 mmol/L, HCO3 1.39 mmol/L

OTHER TEST CONDITIONS
- Adjustment of pH: No

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
At each renewal time: living fish larvae were counted and outward appearance and condition was compared with controls. Twenty eight days after hatching, the length and weight of each young fish was determined

RANGE-FINDING STUDY
- Results used to determine the conditions for the definitive study: no great effects on the egg-larval development could be expected at 1000 mg/L dilution water. It was also found that larvae that were a few days old died within a few days when exposed to 3200 mg/L.

POST-HATCH DETAILS
- Begin of post-hatch period: during 6th and 7th day of test
- No. of hatched eggs (alevins)/treatment released to the test chamber:
- Release of alevins from incubation cups to test chamber on day no.:
Reference substance (positive control):
no
Duration:
35 d
Dose descriptor:
NOEC
Effect conc.:
>= 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: length, weight, hatching, survival, condition.
Duration:
35 d
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: length, weight, hatching, survival, condition.
Details on results:
- Mortality/survival at embryo and larval stages: no differences between groups
- Days to hatch or time to release of young: day 6-7
- Numbers hatched: Control: 51/60, 100 mg/L: 54/60, 180 mg/L: 50/60, 320 mg/L: 49/60, 560 mg/L: 54/60, 1000 mg/L: 53/60
- Observations on mean body length (mm) after 35 d of exposure: Control: 11.6, 100 mg/L: 11.2, 180 mg/L: 11.7, 320 mg/L: 11.5, 560 mg/L: 11.5, 1000 mg/L: 10.7
- Observations on mean body weight (mg) after 35 d of exposure: Control: 22.8, 100 mg/L: 20.9, 180 mg/L: 22.6, 320 mg/L: 22.8, 560 mg/L: 22.3, 1000 mg/L: 20.3
- Number of healthy fish at end of test: Control: 51/60, 100 mg/L: 51/60, 180 mg/L: 50/60, 320 mg/L: 49/60, 560 mg/L: 53/60, 1000 mg/L: 51/60
Executive summary:

Melamine was tested for influence on the egg-larval development of the fresh water fish species Jordanella floridae. Five concentrations of melamine in standard dilution water were tested: 100; 180; 320; 560; and 1,000 mg/L.

At none of the concentrations tested an influence was found on the hatching ability of the eggs or on the appearance of the newly born larvae and on survival, on the condition (visually assessed) or colour of the fish larvae during the 28 day exposure period after hatching.

Neither at 560 mg/L nor at the lower concentrations tested was any influence found on the length or weight of the fish larvae at the end of the test. At 1000 mg/L the length and weight of the fish larvae at the end of the test were slightly less than those of the fishes in the other test solutions, but the differences were not significant.

Endpoint:
fish early-life stage toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please refer to the analogue justification attached to section 13
Reason / purpose:
read-across source
Duration:
35 d
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: length, weight, hatching, survival, condition.
Duration:
35 d
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: length, weight, hatching, survival, condition.

Description of key information

Key value for chemical safety assessment

EC10, LC10 or NOEC for freshwater fish:
1 000 mg/L

Additional information

Data on the chronic toxicity of the target substance diphosphoric acid, compound with 1,3,5-triamine (1:2) to fish are not available. The evaluation of the chronic toxicity to fish is based on a read across approach with available data on the source substance melamine (CAS 108-78-7). The read across approach is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. Further justification is given in the analogue justification in IUCLID section 13.

The available study on the chronic toxicity of melamine (CAS 108-78-7) investigated the effect of the substance on the egg-larval development of the fresh water fish Jordanella floridae. Eggs (<6 hours after laying) were exposed to nominal test substance concentrations of 100, 180, 320, 560 and 1000 mg/L in a semi-static test. The number of eggs hatched and the development and condition of surviving fish was recorded. Significant effects on any of the effect parameters were not observed. The determined NOEC (35 d) was > =1000 mg/L.