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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
Study period:
From January 25, 2010 to February 03, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Polynt Lot No. T408209159
- Manufacturing date: 08 Jun 2009
- Expiration date of the lot/batch: 08 Jun 2010

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Keep container tightly closed. Keep in a dry, cool and well ventilated place.
- Stability under test conditions: The test material reacts forming the corresponding acid: 1,2-Cyclohexanedicarboxylic acid, 4-methyl- (in water and light at room temperature).
- Storage at testing facility: 5 years
Analytical monitoring:
yes
Details on sampling:
Analytical verification (0 and 96 hours)
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A static limit test was performed with one application at experimental starting
- Controls: 7 fish in dilution water (without test item) were tested under the same test conditions as the test replicates.
- Concentration : 100 mg/L
- The test medium was mixed with an ultraturrax (1 min, 7000 rpm )
- Test volume : About 20 L per vessel.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Gnathostoma, Pisces, Osteichthyes, Teleostei, Salmoniformes, Salmonidae
- Strain: Oncorhynchus mykiss (Rainbow trout)
- Source:
For preliminary test: Forellenzucht Kasselmann, Forellental 12, D-49170 Hagen
For definitive test: Forellenzucht Trostadt GbR, Dorfstr. 7, D-98646 Trostadt
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD): 5.67 cm
- Weight at study initiation : 2.00 g


ACCLIMATION
- Acclimation period: At least 12 days.
- Acclimation conditions (same as test or not): Holding was performed at the test facility at 13 - 17 °C, diffuse light (0.1-10 µmol photons .m-2 . s -1, 12 h photoperiod daily) and under flow-through conditions. The water exchange was 1-2 times the water volume per day.
- Type and amount of food: during acclimatisation food was provided 3 times per week. The test fish were not fed 24 hours before test start. Food type: Aller Performa Gr. 2 (ALLER AQUA A/S, Allervej 130, DK-6070 Christiansfeld). Amount: The amount of food was 4 % of the fish body weight per feeding day.
- Health during acclimatisation (any mortality observed): No mortality was observed during this time. No disease treatments were administered throughout holding and testing.

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
10 - 250 mg CaCO3 / L
Test temperature:
13-17 °C
pH:
6.0 - 8.5
Dissolved oxygen:
The dissolved oxygen concentration was more than 80 % of the air saturation value.
Nominal and measured concentrations:
Sampling date 2010-01-25 2010-01-29
Start of analysis 2010-01-25 2010-02-03

Nominal concentration Hexahydro - 4 Methylphthalic Anhydride

Test item [mg/L] Measured conc. RR Measured conc. RR
[mg/L] [%] [mg/L] [%]

100 93.7 94 109 109
100 pH-control 97.5 98 107 107
Control < LOQ < LOQ
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass tank loosely covered by glass tops were used.
- Material, size, headspace, fill volume: 20 Lt per vessel
- Aeration: Gentle aeration was provided
- No. of organisms per vessel: Fish density in the tanks was < 1 g fish per litre test solution.
- No. of vessels per concentration (replicates): one vessel with 7 Rainbow trout for the test ITEM , one vessel with 7 Rainbow trout where the pH is
adjusted
- No. of vessels per control (replicates): One vessel with 7 Rainbow trout

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin was used for holding and testing. The water was filtered on activated charcoal and aerated for at least 24 hours to remove chlorine.
- pH-value: 6.0 - 8.5
- Hardness: 10 - 250 mg CaCO3 / L


OTHER TEST CONDITIONS
- In one vessel the pH-value of the test medium was adjusted to the pH of the dilution water ± 0.2 by adding appropriate volumes of 7 mol/L NaOH.
- Photoperiod: A daily 12 hours photoperiod occurred during the test.
- Light intensity: 0.1 -10 µmol photons . m-2 . s-1
- Feeding of the test fish: The fish were not fed during the test.

Reference substance (positive control):
no
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
The limit test concentration caused no mortality or non-lethal effects in both test vessels (with and without adjustment of the pH-value) at a concentration of 100 mg/L.

Cumulative Mortality [%] in the Test Vessels

(n=7)

Nominal test item concentration

[mg/L]

Test Duration [hours]

2 – 4

24

48

72

96

100

0

0

0

0

0

100 (pH-control)

0

0

0

0

0

Control

0

0

0

0

0

Validity criteria fulfilled:
yes
Conclusions:
In this study Hexahydro - 4 Methylphthalic Anhydride (4-MHHPA) did not cause any effects to Rainbow trout after 96 hours tested with the limit concentration of 100 mg/L test item, with and without adjustment of the pH-value.
Executive summary:

Acute toxicity to fish of 4 -MHHPA has been investigated in accordance with OECD/EU test methods. A static limit test was conducted with a single test item concentration of 100 mg/L with and without adjustment of the pH-value. No mortality occurred over the 96 hour duration of the test.

Description of key information

Acute toxicity to fish: LC50 = > 100 mg/L; NOEC = 100 mg/L

Key value for chemical safety assessment

LC50 for freshwater fish:
100 mg/L

Additional information

Acute toxicity to fish of 4-MHHPA has been investigated in accordance with OECD/EU test methods. A static limit test was conducted with a single test item concentration of 100 mg/L with and without adjustment of the pH-value. No mortality occurred over the 96 hour duration of the test. These findings are supported by a test on the acid degradation product in which the 48 hour LC50 was determined to be >= 500 mg/L.