Isocyanic acid, polymethylenepolyphenylene ester, 2-ethyl-1-hexanol-blocked

Bioaccumulation: aquatic / sediment

Administrative data

Endpoint:

bioaccumulation in aquatic species: fish

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study carried out according to official guidelines and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

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:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-methylenediphenyl diisocyanate

EC Number:

202-966-0

EC Name:

4,4'-methylenediphenyl diisocyanate

Cas Number:

101-68-8

Molecular formula:

C15H10N2O2

IUPAC Name:

1,1'-methylenebis(4-isocyanatobenzene)

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.

Radiolabelling:

yes

Test solutions

Vehicle:

yes

Test organisms

Test organisms (species):

Cyprinus carpio

Details on test organisms:

Size 5.8-7.4cm

Study design

Route of exposure:

aqueous

Test type:

flow-through

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

pH:

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 factor

Bioaccumulation factor 1

Type:

BCF

Value:

92

Calculation basis:

steady state

Remarks on result:

other: Conc.in environment / dose:0.8 micrograms/l

Bioaccumulation factor 2

Type:

BCF

Value:

200

Calculation basis:

steady state

Remarks on result:

other: Conc.in 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

Conclusions:

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).