Registration Dossier

Diss Factsheets

Ecotoxicological information

Long-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
adult fish: sub(lethal) effects
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
9-Oct-2001 to 30-Oct-2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was given a reliability rating of 1 because it followed a standard test guideline, which describes a procedure to evaluate this endpoint, and the results were reviewed for reliability and assessed as valid. The study was also conducted under GLP.
Justification for type of information:
Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, aromatics (2-25%) straddles Hydrocarbons, C9-C14, Aliphatics, (2-25% Aromatics) and Hydrocarbons, C14-C20, Aliphatics (2-30% Aromatics). Read across justification documents have been provided for the same in Section 13 of the dossier. For this substance, a worst case scenario approach has been used for each endpoint.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
Deviations:
yes
Remarks:
Deviations did not impact the validity of the study.
Principles of method if other than guideline:
Study duration 21 days instead of 14 days as suggested by test guideline.
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
Samples were removed from the control and 2500 and 5000 mg/l concentrations on Day 0, 7, 14, and 21 of the study.
Vehicle:
no
Details on test solutions:
Test solutions were prepared as Water Accommodated Fractions (WAF). The test substance was added to test water, and stirred for 23 hours with a magnetic stirrer until equilibrium. The mixing was done at a slow enough speed as to not cause dispersion or emulsification of the undissolved test substance. The solution was allowed to stand for approximately 1 hour, to allow phase separation, before being carefully siphoned out via a glass tube (added prior to the addition of the test substance). Renewal of the test WAF was conducted every 24 hours.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Brachydanio rerio (Teleostei, Cyprinidae)
Source of supply - MPI Tubingen
Pre-treatment - the animals were held for >12 days, <5% mortality
(light/dark = 14h / 10h; illumination: GroLux fluorescent tubes).
The animals were 3.0 to 3.5 cm in size.
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Test temperature:
20.7 to 23.7 dec C
pH:
8.3 to 8.5
Dissolved oxygen:
>75%
Salinity:
freshwater
Nominal and measured concentrations:
Nominal concentrations were: 0, 2500, 5000 mg/l.

Concentration analysis (TOC) of the control and 2500 and 5000 mg/l test concentrations gave results of <10 mg/l. Indicating very low solubility of the test substance.
Details on test conditions:
10 animals/conc.
20 L glass aquaria with aeration via glass pipette.
14h light / 10h dark.
Animals were fed 1 time per day
Reference substance (positive control):
no
Key result
Duration:
21 d
Dose descriptor:
LL50
Effect conc.:
> 5 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Key result
Duration:
21 d
Dose descriptor:
NOELR
Effect conc.:
5 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
Percent Mortality: (at end of test)
Control - 0%
2500 mg/l - 0%
5000 mg/l - 0%

Validity criteria fulfilled:
yes
Conclusions:
The chronic toxicity of Hydrocarbons, C11 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%) as measured by toxicity to the zebrafish (Brachydanio rerio) was evaluated in freshwater. Hydrocarbons, C11 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%) did not show toxic effects as a Water Accommodated Fraction (WAF) with a 21 -day LL50 of >5000 mg/l and is not chronically toxic to fish.
Executive summary:

The chronic toxicity of Hydrocarbons, C11 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%) as measured by toxicity to the zebrafish (Brachydanio rerio) was evaluated in freshwater. Hydrocarbons, C11 -C20, n-alkanes, isoalkanes, cyclics, aromatics (2 -30%) did not show toxic effects as a Water Accommodated Fraction (WAF) with a 21 -day LL50 of >5000 mg/l and is not chronically toxic to fish.

Description of key information

There is no data available for this substance. However, key data is available for the structural analogue Hydrocarbons, C11-C20, n-alkanes, Isoalkanes, cyclics, 2 -30% aromatics. The data for this substance is presented in this dossier. The data is read across to these substances based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

Hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics (2-30%) did not cause toxicity to fish in a 21-day toxicity study withBrachydanio reriofollowing standard test guidelines at a nominal loading of 5000 mg/L. These results indicate that hydrocarbons, C11-C20, n-alkanes, isoalkanes, cyclics, aromatics ( -30%) is not expected to be chronically toxic to fish.

 

Key value for chemical safety assessment

Additional information