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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study without restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Formaldehyde, oligomeric reaction products with aniline
EC Number:
500-036-1
EC Name:
Formaldehyde, oligomeric reaction products with aniline
Cas Number:
25214-70-4
Molecular formula:
(C6 H7 N)2 (C H2)m+1(C6H6N)m or C7m+13H6m+13Nm+2
IUPAC Name:
Poly[(aminophenyl)methyl]aniline
Constituent 2
Reference substance name:
Formaldehyde, oligomeric reaction products with aniline (oligomeric MDA, PMDA)
IUPAC Name:
Formaldehyde, oligomeric reaction products with aniline (oligomeric MDA, PMDA)
Details on test material:
- Name of test material (as cited in study report): Formaldehyde, oligomeric reaction products with aniline
- Physical state: solid
- Analytical purity: 93.45 g/100g
- Impurities (identity and concentrations): no data
- Expiration date of the lot/batch: 15 Apr 2015

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Each test solution was prepared separately using a solidliquid (slow-stir) saturator technique, as described in US EPA 2002. Briefly, this technique involved coating the inside surface of a glass vessel with the test substance to generate a saturated solution. For correct dosing of the test substance, a stock solution (1 g/L) was prepared in Tetrahydrofurane (THF). The test substance was completely dissolved in the THF and the stock solution appeared colorless and clear. The solvent stock solution and as needed an additional amount of THF (to normalize the quantity of solvent used in each treatment) was distributed on the bottom of a 2-L beaker. Each beaker was rotated while the THF evaporated, maximizing the surface area of the thin layer of test substance coating the inside surface of the vessel, until the solvent was completely evaporated. Afterwards 1000 mL of test medium (M4) was added to the vessels taking care to minimize the disturbance of the test substance layer and they were gently shaken (at 50 rpm) at the test temperature for about one day. The beakers were wrapped in aluminum foil to protect the solution from ambient light exposure. Since the THF was completely evaporated prior to adding test media, no solvent was used togenerate the test solutions themselves.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): CAS 109-99-9, tetrahydrofurane
- Concentration of vehicle in test medium (stock solution and final test solution): none
- Evidence of undissolved material (e.g. precipitate, surface film, etc): no

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: water flea
- Strain: Straus
- Source: supplied by the Institut National de Recherche Chimique Appliquée, France, in 1978. From this date on this clone was cultured and bred continuously in the Ecotoxicology Laboratory of Experimental Toxicology and Ecology, BASF SE, Ludwigshafen Germany.
- Age at study initiation (mean and range, SD): <24h (at least 3rd brood progeny)
- Feeding during test: none
- Food type:

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Test temperature:
20.4 – 20.8 °C
pH:
7.9-8.1
Dissolved oxygen:
4.0-8.9 mg/L
Nominal and measured concentrations:
Nominal: 0, 0.1, 0.22, 0.46, 1, 2.2 and 4.6 mg/L
Masured: 0.05, 0.11, 0.26, 0.52, 1.1 and 2.4 mg/L (initial and after 48 hours)
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: nominal volume 100 mL
- Aeration: none
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: A synthetic fresh water (Elendt M4) is used as media for culture and test purposes.
- Ca/mg ratio: about 4 : 1
- Conductivity: 550 - 650 μS/cm
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: Since the test substance is light sensitive according to the recommended storage conditions, the experiment was conducted without light exposure.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: ca. 2.2
Reference substance (positive control):
yes
Remarks:
potassium dichromate

Results and discussion

Effect concentrations
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.57 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Results with reference substance (positive control):
- Results with reference substance valid? yes
- EC50/LC50: The EC50(24h) of the reference substance potassium dichromate was 1.13 mg/L (experiment date: 24 Oct 2011, project number: 50E0063/043039)

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Due to the EC50 (48h) of 0.57 mg/L (related to mean measured concentrations) the substance is condifered acutely very toxic to aquatic organisms.