Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: A guideline study performed in compliance with the GLP regulations

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
not specified
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Principles of method if other than guideline:
The procedures employed were based on the relevant OECD and EEC test guidelines.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
The test sample of PTH-Decahydroamide (Lot No. 25927) was supplied by Battelle Geneva Research Centres for and on behalf of F Hoffmann-La Roche Ltd. The sample was received on 6 May 1994 and was assigned the Laboratory code AA0447.Information supplied with the test sample indicated that it had a purity of 99.8% (Analytical certificate no. 25927, dated 25 January 1994). The test sample was a white to light yellow solid. It was stored at ambient temperature, in the container in which it was received, until required for testing when an appropriate subsample was provided for the test operator.
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not relevant.

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Samples were taken for analysis at the start and end of the 96 hour exposure period. Aqueous samples were extracted into dichloromethane, blown down to dryness and taken back up in hexane.

Test solutions

Vehicle:
no
Details on test solutions:
Test solutions ranged from a very fine suspension at 5.6 mg/L to a fine white suspension at 100 mg/L, after 24 hours all test concentrations cleared.

Test organisms

Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
The test organism was the rainbow trout ( Oncorhynchus mykiss) a sensitive freshwater fish. The fish were obtained from Exmoor Trout Farm, North Molton, North Devon, UK on 15 June 1994 and held in stock tanks at the Brixham Environmental Laboratory.

Prior to the test the fish were acclimatised to the test temperature (15 ± 1oC) for a minimum period of 7 days. During the holding and acclimatisation periods the fish were fed appropriate amounts of a commercial fish food. Food was withheld from the fish for at least 24 hours prior to the commencement of the test.

The fish tested ranged in weight from 1.10 to 3.12 g with a mean weight of 1.86 g. The range in length was 42 to 60 mm with a mean length of 50 mm (data as measured on the control fish at the end of the test).

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
Not relevant.

Test conditions

Hardness:
The total hardness of the dilution water was 43.6 mg/1 CaC03 , and the conductivity of the water was 282 micro-siemens/cm.
Test temperature:
The temperatures recorded were within the range 15 ± 1 °C.
pH:
The pH values ranged from 7.33 to 9.19
Dissolved oxygen:
Dissolved oxygen concentrations in the test vessels ranged from 9.2 to 10.0 mg/1.
Salinity:
Not applicable
Nominal and measured concentrations:
The mean measured concentrations were 5.5, 8.9, 17, 34, 66 and 110 mg/L in the nominal 5.6, 10, 18, 32, 56 and 100 mg/L test treatments. As the mean measured concentrations were within 80 to 120% of nominal concentrations the results of the study are based on nominal exposure concentrations.
Details on test conditions:
No further details were provided.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
68 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95 % confidence intervals between 57 to 84 mg/l
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
68 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95 % confidence intervals between 57 to 84 mg/l
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
68 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95 % confidence intervals between 57 to 84 mg/l
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
68 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 95 % confidence intervals between 57 to 84 mg/l
Dose descriptor:
LC100
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
At the end of the 96 hour exposure period mortality in the nominal 5.6, 10, 18, 32, 56 and 100 mg/L treatments was 0, 0, 0, 0, 10 and 100%. The highest concentration causing no mortality was 32 mg/L and the lowest concentration causing 100% mortality was 100 mg/L.
Results with reference substance (positive control):
Not relevant.
Reported statistics and error estimates:
The LC50 is defined as the concentration, calculated from the data obtained, resulting in the death of 50% of the fish in the time period specified. A 95% confidence interval for all values was reported.

Any other information on results incl. tables

Not applicable

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The study was performed according to EC directive 92/69/EEC, C. 1 (1992) and OECD guideline No. 203 (1992). Under the conditions of the present study the 96h-LC50 of PTH-decahydroamide to rainbow trout was determined to be 68 mg/L, with 95 % confidence intervals between 57 to 84 mg/L.

The highest concentration causing no mortalility within the test period was 32 mg/L and the lowest concentration causing 100 % mortalility was 100 mg/L.
Executive summary:
The 24, 48, 72 and 96 hour median lethal concentrations (LC50) of PTH-Decahydroamide to the freshwater fish rainbow trout (Oncorhynchus mykiss previously known as Salmo gairdneri) were determined under static test conditions at a temperature of 15 ± 1 °C. The mean measured concentrations ranged from 89 to 118% of the nominal exposure concentrations. The results were based on the nominal exposure concentrations of PTH-Decahydroamide. The 96 hour LC50 = 68 mg PTH-Decahydroamide/litre with 95% confidence intervals of 57 to 84 mg/L The highest test concentration causing no mortality within the period of the test was 32 mg/L. The lowest that caused 100% mortality within the period of the test was 100 mg/L.