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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
5.4. 1993 - 9.4. 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes (incl. QA statement)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Cosmacol EMI, Butanedioic acid, hydroxy-, di C12-C13-alkyl esters
- Molecular weight (if other than submission substance): 470 - 498
- Substance type: pure active substance
- Physical state: liquid

Sampling and analysis

Analytical monitoring:
no
Details on sampling:
- Concentrations: 100 mg/L (dispersion concentration)

Test solutions

Vehicle:
no
Details on test solutions:
Identity and concentration of auxiliary solvent for dispersal: NOTHING

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Brachidanio rerio
- Strain: Teleostean
- Source: Aquarin Italy - V.le Ungheria, 19 - MI
- Age at study initiation (mean and range, SD): not mentioned
- Length at study initiation (length definition, mean, range and SD): 3 cm +- 0.5 cm
- Weight at study initiation (mean and range, SD): not mentioned
- Food type: Powdered fish food (Tetramin) containing fish, cereal shellfish, crustaceans, oil and fat, algae, sugars and vitamin A - D3 - E form tetrawerke - germany - imported into Italy by Euraquarium S.p.A. - Bologna
- Frequency: daily, suspended 24 hours before the beginning of the study

Study design

Test type:
static
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
180 mg CaCO3/L
Test temperature:
22 ° C +-2 ° C
pH:
6 - 8.5
Dissolved oxygen:
> 6 mg/L
Nominal and measured concentrations:
The concentrations couldn't be measured.
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 L aquarium
- Aeration: continuous with porous stones
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

OTHER TEST CONDITIONS
- Adjustment of pH: not mentioned
- Photoperiod: 12 h/d with fluorescent lamps

TEST CONCENTRATIONS
- Test concentrations: 100 mg/L (dispersion concentration), 0 mg/L
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
not specified
Conc. based on:
other: dispersion concentration
Basis for effect:
mortality (fish)
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
not specified
Conc. based on:
other: dispersion concentration
Basis for effect:
mortality (fish)
Duration:
72 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
not specified
Conc. based on:
other: dispersion concentration
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
not specified
Conc. based on:
other: dispersion concentration
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
not specified
Conc. based on:
other: dispersion concentration
Basis for effect:
mortality (fish)
Details on results:
100 mg of the test substance was mixed with 1 litre of water. this quantity, which was in excess of the water solubility (1 mg/L) of the same substance did not cause any disturbance to the fish. It was not possible, with the analytical technology available to measure the concentration of the substance in the solution.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Executive summary:

A group of 20 Brachidanio rerio was used, of which 10 were treated with Cosmacol EMI at a concentration (100 mg/L dispersion concentration) exceeding the solubiliy of the substance (1 mg/L), 10 were used as a control, kept in the same conditions without adding the test material.

During the study no toxic symptoms or mortality were observed in the treated and the control group.