Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
fish early-life stage toxicity
Type of information:
(Q)SAR
Adequacy of study:
key study
Study period:
November 2018
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Deviations:
not applicable
Remarks:
QSAR
Principles of method if other than guideline:
The chronic toxicity to fish was determined using a validated QSAR for the Mechanism of Action (MechoA) in question (MechoA 1.1, i.e. non-polar narcosis) (3). The QSAR is based on validated data for a training set of 26 chemicals derived from 14 to 32-day test on fish, for which the concentrations of the test item had been determined by chemical analyses over the test period.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetradecafluorohexane
EC Number:
206-585-0
EC Name:
Tetradecafluorohexane
Cas Number:
355-42-0
Molecular formula:
C6F14
IUPAC Name:
tetradecafluorohexane
Test material form:
liquid

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Results from the following species were used in the regression:

Danio rerio, Pimephales promelas, Oryzias latipes, Leuciscus idus, Jordanella floridae, Cyprinus carpio

Study design

Test type:
flow-through
Water media type:
not specified
Total exposure duration:
28 d
Remarks on exposure duration:
Only results from a test duration of 14* to 32 days were included. The median study duration was 28 days.

Test conditions

Test temperature:
The temperatures varied from approximately 21 to 27 °C depending on the fish species used to construct the algorithm.
pH:
Test results were taken from studies with measured pHs between 6.0 - 8.5

Results and discussion

Effect concentrations
Key result
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
ca. 0.11 mg/L
Nominal / measured:
estimated
Conc. based on:
test mat.
Basis for effect:
not specified
Remarks on result:
ChV (chronic value, QSAR)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The test item falls within the applicability domain of the model and can therefore be considered a reliably prediction for chronic toxicity (28d-NOEC) to fish. Therefore, this endpoint value can be considered valid for use in risk
assessment and classification and labelling.
The 28d-NOEC of the test item to fish was predicted as 0.11 mg/L.
95% confidence interval (α = 0.05): 0.087 – 0.14 mg/L.
The QPRF can be found as a separate document (8).
The QMRF can be found as a separate document (9).
Executive summary:

Introduction.

A QSAR model model was used to calculate the chronic toxicity to fish of the test item 1,1,1,2,2,3,3,4,4,5,5,6,6,6-TETRADECAFLUOROHEXANE. This QSAR model has been validated to be compliant with the OECD recommendations for QSAR modeling (OECD, 2004) (1) and predicts the endpoint value which would be expected when testing the substance under experimental conditions in a laboratory following Guideline for Testing of Chemicals No. 210, "Fish, Early-life Stage Toxicity Test" (2). The criterion predicted was the NOEC (No Observed Effect Concentration), a tested concentration which is observed to cause no effect on growth or reproducibility within a period of 28 days.

Methods.

The chronic toxicity to fish was determined using a validated QSAR for the Mechanism of Action (MechoA) in question (MechoA 1.1, i.e. non-polar narcosis) (3). The QSAR is based on validated data for a training set of 26 chemicals derived from 14 to 32-day test on fish, for which the concentrations of the test item had been determined

by chemical analyses over the test period.

Results.

The result below is the chronic toxicity value anticipated during a 28-day NOEC study on fish. The 28-day

NOEC is calculated as follows:

Time (d)

NOEC (mg test item.L-1)

95% confidence limits (mg test item.L-1)

 

28

 

0.11

 

0.087 – 0.14