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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

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Administrative data

Endpoint:
direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Information published in peer reviewed literature.

Data source

Reference
Reference Type:
publication
Title:
Detection and Quantification of Polycyclic Musk Fragrance Materials in Human Fat and Mother's Milk Using Ion Trap GC/MS/MS.
Author:
Eschke, E.D., Dibowski, H.J., and Traud, J.
Year:
1995
Bibliographic source:
Deutsche Lebensmittel - Rundschau, 91 (12): 375-379.

Materials and methods

Study type:
other: Analysis of HHCB in adipose tissue and milk
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
In a study (non-GLP) to measure residues of HHCB, two human fat samples (origin not specified) were extracted with hexane and the extracts analysed by selective ion trap gas chromatography (GC)/mass spectrometry (MS) for residues of HHCB. In the same study two human milk samples (origin not specified) were extracted with hexane and the extracts analysed by GC/MS for residues of HHCB.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Galaxolide (HHCB)

Results and discussion

Any other information on results incl. tables

HHCB concentrations ranged from 145 to 149 ug/kg lipids in human fat and 310-350 ug/kg lipids in human milk.  This is
approximately equivalent to 6 - 7 ug/kg in human milk (based
on a fat content of 2% in human milk).In the same study two human milk samples (origin not specified) were extracted with hexane and the extracts analysed by GC/MS for residues of HHCB. Residues in blood were found in both samples at levels of 310 and 360 µg/kg fat or 3.3 and 1.5 µg/kg (ppb) whole milk based on measured fat contents of 1.06 and 0.41%, respectively.

Applicant's summary and conclusion

Conclusions:
Residues of HHCB (ug range/kg fat) were found in human fat and milk samples. The small number of samples used in the present study does not permit a generally valid conclusion to be drawn concerning the loading in man.
Executive summary:

In a study (non-GLP) to measure residues of HHCB, two human fat samples (origin not specified) were extracted with hexane and the extracts analysed by selective ion trap gas chromatography (GC)/mass spectrometry (MS) for residues of HHCB. Residues were found in both samples at levels of 145 and 149 µg/kg fat. In the same study two human milk samples (origin not specified) were extracted with hexane and the extracts analysed by GC/MS for residues of HHCB. Residues were found in both samples at levels of 310 and 360 µg/kg fat or 3.3 and 1.5 µg/kg (ppb) whole milk based on measured fat contents of 1.06 and 0.41%, respectively.