Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 1989, october 30th to 1989, november
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the Test Guidelines described in the EEC Directive 84/449/EEC

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
EC Number:
406-200-8
EC Name:
3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
Cas Number:
117827-06-2
Molecular formula:
C24H39Cl2NO2
IUPAC Name:
N-(3,5-dichloro-4-ethyl-2-hydroxyphenyl)hexadecanamide
Details on test material:
UC-136
RCC notox substance: 1763
RCC Notox old project: 1343
White powder
Purity 98.5%
Storage conditions: at room temperature in the dark in a tighly sealed container
Stability of test substance: stable for one year maximal under storage conditions
Expiry date: january 5 1990
Stability in vehicles : unknown
Safety precautions: gloves and goggles were used to assure personnel health and safety

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Species : Daphnia magna (Crustacea, Cladocera) ( Straus, 1820)
Breeding: Synchronously in DSW with a density of 25 daphnia per litre in a climate room.
Start of’ each batch With newborn animals, i.e. less than 3 days old, by placing about 250 of them into 10 litres of DSW in an all—glass culture vessel.
Maximum age of the cultures 4 weeks
Renewal of’ the cultures After 7 days of cultivation half of the volume medium twice a week.
Reason for selection This system has been selected as an internationally accepted species and recommended by the referred guidelines.
Medium Dutch standard water (DSW): formulated using Milli—Q water according to Adema (Adema D.M.M., 1980; in: Degradability, Eco—toxicity
and Bioaccumulation: The determination of the possible effects of chemicals and wastes on the aquatic environment, Chapter 5, Government Publishing Office, The Hague, The Netherlands).
Milli—Q water: tap water purified by reverse osmosis and subsequently passed over activated carbon and ion—exchange cartridges (Millipore Corp., Bedford, Mass., USA).
Temperature 20± 2°C
Feed A suspension of fresh water algae.
Frequency Once a day
Characteristics For the test selection of young daphnia with an age of <24 hours.
Validity of batch Frequent inspection of the cultures with respect to number of young, appearance of young and parental daphnia and global feedingbehaviour.
Control of sensitivity In a 24—hour reference test with potassium di chromate.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
24 h

Test conditions

Hardness:
11.7°DH
Test temperature:
19.0 to 20.0°C
pH:
7.8 to 8.3
Dissolved oxygen:
> 5 mg/L
Salinity:
Ca2+ 54.5 mg/L
Mg2+ 17.8 mg/L
Na+ 27.4 mg/L
K+ 7.8 mg/L
Cl- 96.3 mg/L
a) CO3 2- ---
b) HCO3- 84.8 mg/L
SO4 2- 70.2 mg/L
Nominal and measured concentrations:
an oversaturated solution of 1000mg/L infiltrated and filtrated (=saturated solution)
Details on test conditions:
Identification The vessels were individually identified by means of’ adhesive labels as described in detail in RCC NOTOX’s Standard Operating Procedures.
Method As described in the guideline with some mociifications, in accordance with the standard operation procedure: SOP ET/1641.
Test type Limit test, static Test duration 24 hours Test vessels 250 ml, all—glass
Test medium Dutch standard water.
Number of daphnia 20 per concentration
Loading 10 per vessel
Light 16 hours photoperiod daily
Room temperature 20.0°C
Feeding No feeding
Concentration range Because the test substance was hardly soluble in water a limit study was performed, i.e. exposure to an oversaturated solution of 1000 mg/l unfiltrated and filtrated (=saturated solution).
Controls Blank: test medium without test substance or other additives.
Treatment stock solutions The test substance was hardly soluble in water.
Preparation of the stock solution: 958.4 mg of test substance was quantitatively added to 1000 ml medium providing a stock solution of 1000 mg/l. This oversaturated stock solution was stirred for 48 hours.
Subsequently, from this solution 200 ml was taken and filtrated over a 45 um filter and as such tested, Le. 2x100 ml divided over 2 vessels.
From the stirred solution another 2x100 ml were taken and tested without filtration.
In these solutions precipitation of test substance was present.
Introduction of young daphnia The daphnia were introduced into the test medium within approximately 30 minutes after preparation of the test media.
Reference substance (positive control):
yes
Remarks:
The reference substance potassium dichromate was tested at the same time as the final test with UC—136, using daphnia from the same culture (Table 4). The 24—hour EC5O was 1.04 mg/l, which is within the expected range: 0.56—1.91 mg/l (n=20).

Results and discussion

Effect concentrations
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 1 000 mg/L
Nominal / measured:
nominal

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of the present study the test substance UC-136 appears to induce no immobility when Daphnia magna are exposed to either a saturated or an oversaturated solution.