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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

bioaccumulation in aquatic species: fish
Type of information:
experimental study
Adequacy of study:
other information
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study carried out according to official guidelines and GLP.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 305 E (Bioaccumulation: Flow-through Fish Test)
Principles of method if other than guideline:
"Bioconcentration Test of Chemical Substance on Fish" provided in "Test method on new chemical subsatnce" (Kan-Ho-Gyo No. 5, Yaku-Hatu No. 615, 49 Ki-Kyoku No. 392, July 13, 1974, revised October 8, 1998) and "Bioconcentration: Flow-through Fish Test (Guideline 305, June 14, 1996" provided in "OECD Guidelines for Testing of Chemicals".
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
4,4'-methylenediphenyl diisocyanate
EC Number:
EC Name:
4,4'-methylenediphenyl diisocyanate
Cas Number:
Molecular formula:
Details on test material:
Labeled test item:Trade name: 4,4'Methylene bis([ring-U-14C]phenylisocyanate)Specific radioactivity: 2.44 GBq/mmolLot number: CFQ12861Radiochemical purity: 98.8% (radio-GC)Labeled test material counted as 100% pure material.Non-labeled test item:Trade name: Diisocyanate 4,4'-diphenylmethaneQuality grade: Chemical useLot number: LDH4438Purity: >= 95.0%Non-labeled material counted as 100% pure material.

Test solutions


Test organisms

Test organisms (species):
Cyprinus carpio
Details on test organisms:
Size 5.8-7.4cm

Study design

Route of exposure:
Test type:
Water / sediment media type:
natural water: freshwater
Total exposure / uptake duration:
28 d

Test conditions

Test temperature:
Concentration Level 1: 25.0 - 25.2 degrees C
Concentration Level 2: 25.0 - 25.2 degrees C
Control: 25.0 - 25.5 degrees C
Concentration Level 1: 7.2 - 7.5
Concentration Level 2: 7.2 - 7.4
Control: 7.2 - 7.4
Dissolved oxygen:
Concentration Level 1: 7.4 - 7.6 mg/l
Concentration Level 2: 7.2 - 7.6 mg/l
Control: 7.3 - 7.9 mg/l
Details on test conditions:
Water media type: Tap water of Tokyo laboratory treated through activated carbon filtration. The water was analysed and quality shown to meet the standards required for the toxicity test (full details supplied).

The master solution was delivered to the test vessel (at a rate of 0.04ml/min) simultaneously with test water (delivered at 400ml/min). This gave a total of 576 L/day delivered to the test vessel (capacity 50L).
Nominal and measured concentrations:
nominal concentration level 1: 0.8 microgram/l
nominal concentration level 2: 0.08 microgram/l

Results and discussion

Lipid content
Lipid content:
4.52 %
Time point:
end of exposure
Bioaccumulation factoropen allclose all
Calculation basis:
steady state
Remarks on result:
other: environment / dose:0.8 micrograms/l
Calculation basis:
steady state
Remarks on result:
other: environment / dose:0.08 micrograms/l
Details on results:
Test concentration level 1 0.8 microgram/l
BCF: 92

Test concentration level 2 0.08 microgram/l
BCF: 200

Any other information on results incl. tables

Results indicate low potential for bioaccumulation however it should be noted that liquid scintillation counting was the method of analysis for all water and fish samples and no analysis of 4,4'-MDI itself was carried out during the course of the study.

Applicant's summary and conclusion

MDI is virtually unavailable in aqueous solution, and in consequence no bioaccumulation of the substance is expected. The bioconcentration of 4,4’-MDI has been evaluated in this study, using flow-through exposures of 0.8 and 0.08 ug/L MDI. Whereas the analytics (liquid scintillation counting) for this study are suspect due to the expected reactivity of MDI in water and fish tissues, steady state bioconcentration factors (BCFss) of 92 and 200 are reported for these respective MDI exposure concentrations. Using a similar test procedure with (Cyprinius carpio), no measureable bioconcentration of the 4,4'-MDA substance, present at only low concentrations from reaction of MDI with water, was observed. Based on the exposure concentration (0.2 and 0.02 mg/L) and analytical detection limits for water and fish tissues, BCF values of 3-14 and <3-15 (respectively) were reported for these MDA exposures. (EU Risk Assessment Report 4,4’-methylenedianiline).