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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 29/01/09 to 30/03/09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study conducted under good laboratory practices

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Isosorbide Diesters
EC Number:
700-073-5
Cas Number:
1215036-04-6
Molecular formula:
As it is an UVCB, we can not provide the exact molecular formula.
IUPAC Name:
Isosorbide Diesters
Details on test material:
- Name of test material (as cited in study report): LAB 3822

- Physical state: LIQUID

- Lot/batch No.: FAL 07/25
- Expiration date of the lot/batch: March 2009

- Storage condition of test material:at room temperature but preferably between 10 and 15°C

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
The LAB 3822 is slightly soluble in water (≤ 5mg/l). In order to test the dissolved part of the test item, a stock solution at 1000 mg/L was prepared, for each renewal, in dilution water as follows: 1/ Ultrasonication of the test item (1 g) during 10 minutes in about 500 mL of dilution water 2/ 450 mL are collected in a 1 liter flask 3/ Ultrasonication of the 50 mL residual solution during 2 minutes in about 100 mL of dilution water 4/ 150 mL are collected in the 1 liter flask and up to 1 liter with dilution water 5/ Magnetic stirring during 10 minutes 6/ Centrifugation for 30 minutes (3000 g).The test solution was renewed every 24 hours.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Name : Zebrafish Danio rerio
- Source: Elevage de la Grande Rivière (69490 Saint Forgeux, France)

- Length at study initiation (length definition, mean, range and SD):Mean size: 27.5 +/- 1.6 mm
- Weight at study initiation (mean and range, SD): 0.37g +/-0.06g

- Food type: TetraMin Tetra

ACCLIMATION
- Acclimation period:62 days
- Acclimation conditions (same as test or not):same as test

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
240 mg/L expressed as CaCO3
Test temperature:
23°C +/- 1°C in a temperature-controlled room
pH:
7.9
Dissolved oxygen:
8.9 mg/l
Details on test conditions:
Vessel: 5 litres glass vessels filled with 4 litres
Test: 1 blank control + 1 test vessel
Number of animals: 7 fish in 4 litres
Test concentration: 100 mg/L (initial nominal concentration)
Biomass: 0.65 g/L
Feeding: none
Light: 14-hour light / 10-hour dark cycle
Temperature: 23°C  1°C in a temperature-controlled room
Aeration: none
Renewal: every 24 hours (test concentration and control)
Duration: 96 hours
Times of observation: 6 - 24 – 48 – 72 – 96 hours.
Toxic effect: Fish are considered dead if there is no visible movement (e.g. gill movements) and if touching of the caudal peduncle produces no reaction.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
No lethal effect was observed in this test for the LAB 3822 at the nominal concentration of 100 mg/L after 96 hours.
Executive summary:

TEST PURPOSE

Determination, under defined conditions, of the lethal effects of the test item on a test population of Danio rerio.

GUIDELINE OECD

guideline for testing of chemicals No 203: Fish, Acute Toxicity Test (Adopted 17 July 1992).

TEST SYSTEM

Zebrafish Danio rerio

TEST ITEM LAB 3822

TEST CONCENTRATION 100 mg/L (initial nominal concentration).

DURATION 96 hours (semi-static conditions, renewal every 24 hours).

Mortality observed within the test period

 Exposure time  Control  LAB 3822100mg/L
 6h
 24h
 48h
 72h
 96h
 Mortality after 96h (%) 0% 0% 

RESULTS

No lethal effect was observed in this test for the LAB 3822 at the nominal concentration of 100 mg/L after 96 hours.