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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
Monitoring of algae media was performed with DOC. No substance specific analysis was performed.
Qualifier:
according to guideline
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
GLP compliance:
yes
Analytical monitoring:
yes
Vehicle:
no
Details on test solutions:
To accelerate the solution procedure a five fold amount (45 mg/1) of the maximum water solubility of the test substance in the
preliminary test (9 mg/1) was weighed into water, treated for 60 seconds at 8000 rpm.with an ultra-turrax and afterwards stirred
an a magnetic stirrer for 24 hours. To remove undissolved particles, the resulting emulsion was filtered using a folded filter of the
pore size 7-12 gm.
Test organisms (species):
other: Daphnia magna STRAUSS
Details on test organisms:
TEST ORGANISM:
- Parthenogenetic females, age 0 – 24 hours, laboratory bred at BAYER AG Leverkusen, cloned at the Federal Health Office (BGA), Berlin Germany
- Water for aquaculture: M4-medium according to Elendt, version of BGA (1992), originally described in Water Research 24 (9), Sept. 1990; 1157-1167

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h
Hardness:
14.2 °dH (253.47 mg/l CaCO3)

Test temperature:
20.2 °C (after 48 hrs)

pH:
7.9 (after 48 hrs)

Dissolved oxygen:
8.5 mg/l (after 48 hrs)

Salinity:
No data
Nominal and measured concentrations:
Nominal concentration of test substance: 9 mg/l (Analytical value after 0 hour: 5 mg/l, after 48 hours: 6 mg/l, resp.)
Details on test conditions:
TEST SYSTEM:
- water for dilution: M4 -Medium according to Elendt and BGA (1992)
- control: M4 -Medium according to Elendt and BGA (1992)
- photoperiod: 16 hours light, 8 hours dark (illumination 1000 lux)
- cylindric test vessel: diameter 4.0 cm/height 6.5 cm, 20 ml test medium,not ventilated
- number of daphnids per beaker: 10 daphnids (neonates)
- test parameter: immobilization (death)
- method of administration: direct weighing
- test concentration: 1 (9 mg/l) plus 1 control
- replicate: 2 (per concentration/control)
- chemical analysis: TOC
Duration:
48 h
Dose descriptor:
EC0
Effect conc.:
>= 8.3 mg/L
Nominal / measured:
meas. (arithm. mean)
Conc. based on:
other: determined as TOC and back-calculated to the parent compound
Basis for effect:
mobility
Remarks on result:
other: Arithmetic mean of analytical values
Duration:
24 h
Dose descriptor:
EC0
Effect conc.:
>= 9 mg/L
Nominal / measured:
nominal
Conc. based on:
other: determined as TOC and back-calculated to the parent compound
Basis for effect:
mobility
Details on results:
The above test result refers to a concentration of the test substance which was calculated directly from analytically determined TOC values.
Validity criteria fulfilled:
yes
Executive summary:

The acute toxicity of 4,4-methylenedicyclohexyl diisocyanate to Daphnia magna is EC 0 >= 8.3 mg/l at 48 h (Bayer 2000). The result is expressed in terms of arithmetic mean of analytical values. The study was conducted according to the Council Directive 92/69/EEC C.2 (1992).

Description of key information

With the invertebrate Daphnia magna one acute static limit test in accordance with Directive 92/69/EEC, C.2, is available. For a test period of 48 hours an EC50 value of > 8.3 mg/l was determined. At this concentration no mortality was observed (Bayer AG, 2000c).

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates
Dose descriptor:
EC50
Effect concentration:
8.3 mg/L

Additional information

Should read >8.3 mg/L