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Toxicological information

Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Falling short of highest standards concerning aspects of protocol or reporting. Acceptable literature publication.

Data source

Reference
Reference Type:
publication
Title:
Biomonitoring of workers exposed to 4,4'- methylenedianiline or 4,4'- methylenediphenylmethane diisocyanate
Author:
Schütze D, Sepai O, Lewalter J, Miksche L, Henschler D & Sabbioni G
Year:
1995
Bibliographic source:
Carcinogenesis 16: 573-582

Materials and methods

Type of study / information:
Type of experience: Human

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
4,4'-Methylenediphenyl diisocyanate, MDI, no more data.

Results and discussion

Any other information on results incl. tables

In 3/27 cases the MDI level was greater than the detection limit of 3 micrograms/m3. The concentrations were 19, 30 and 11 micrograms MDI/m3.

In 16/26 workers the haemoglobin adduct levels of 4,4'-methylenedianiline (MDA) and N'-acetyl-4,4'-methylenedianiline (AcMDA) were below the detection limits of 20 fmol and 100 fmol, respectively. The detection limits corresponded to 60 and 330 fmol/g Hb, respectively. In the other 10 workers 57-219 fmol MDA/g Hb was present.

After the base treatment of urine, MDA was found in 22/23 cases, and at 20-139 pmol/l. AcMDA was found in 18/23 cases, and at 83-3000 pmol/l. After acid treatment the MDA found in 22/23 cases was 0.66-10.18 nmol/l.

In workers, most of whom were exposed to <20 micrograms MDA/m3, the Hb MDA levels were at 64-895 (2614) fmol/g Hb, and the Hb AcMDA was 299-4214 fmol/g Hb. After acid hydrolysis the urinary MDA was 0.4-40(188) nmol/l.

Applicant's summary and conclusion