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Exposure related observations in humans: other data

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exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Low sensitivity method with widely varying limits of detection, but data considered acceptable for assessment.

Data source

Referenceopen allclose all

Reference Type:
study report
Report date:
Reference Type:
secondary source

Materials and methods

Type of study / information:
Concentrations of MCCPs detected in human and bovine milk-fat
Endpoint addressed:
basic toxicokinetics
Test guideline
no guideline available
Principles of method if other than guideline:
Concentrations of MCCPs in samples of butter/cow milk-fat and randomly selected samples of human breast milk determined by gas-chromatography/high-resolution mass spectrometry (GC-HRMS).
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Alkanes, C14-17, chloro
EC Number:
EC Name:
Alkanes, C14-17, chloro
Cas Number:
Molecular formula:
Substance is a range of chlorinated isomers of C14 to C17 paraffin
Alkanes, C14-17, chloro
Details on test material:
- Name of test material (as cited in study report): medium-chain chlorinated paraffins (MCCPs)
- Substance type: technical product
- Physical state: no data
- Analytical purity: no data
- Composition of test material, percentage of components: C14-17 chlorinated paraffins
- Impurities: no data


Ethical approval:
not specified
Details on study design:
Human milk samples were collected anonymously from 22 women in maternity units (8 from Lancaster and 14 from London) and immediately frozen. Butter samples were bought in 7 regions of Europe and one milk sample obtained from Lancaster. All samples were kept below -20oC until analysed. Milk fat was separated from samples by centrifugation, dissolved in hexane and lipids removed by chromatography. Chloinated paraffins were recovered by solvent extraction on an activated Florisil column (15:85 dichloromethane: hexane followed by 1:1 dichloromethane: hexane) and analysed by gas-chromatography/mass spectrometry. [13C8]mirex was used as internal standard for the analysis.
Exposure assessment:
not specified
Details on exposure:
no data

Results and discussion

Detectable levels of MCCPs were found in cow milk-fat (63 ng/g) and in butter samples from Denmark (11 ng/g), Ireland (52 ng/g) and Wales (8.8 ng/g). Detectable levels of MCCPs were found in only one human milk sample (61 ng/g) from London.

Any other information on results incl. tables

Detection limits in human milk-fat samples varied with sample size, but ranged from 16 to 740 ng/g fat (mean level of 100 ng/g fat) and from 8 to 9.2 ng/g in butter.

Applicant's summary and conclusion

Only one out of 22 human breast milk samples analysed contained detectable levels of MCCPs (61 ng/g fat). Bovine milk/butter fat from England, Wales, Ireland and Denmark had detectable levels of MCCPs of 63, 8.8, 52 and 11 ng/g fat respectively; those from France, Germany and Italy were below detection limits.
Executive summary:

The concentration of MCCPs in human and bovine milk-fat has been determined by gas chromatography/high resolution mass spectrometry. Milk samples from 22 apparently randomly selected women (8 from Lancaster and 14 from London) and bovine milk/butter samples from England and 7 other European regions were analysed.

Detection limits for individual samples were determined and ranged from 16 to 740 ng/g for human milk-fat (with a mean level of 100 ng/g fat) and 8 to 9.3 ng/g for bovine butter-fat. Only one human milk sample had a detectable level of mPCAs (61 ng/g). The bovine milk-fat sample from Lancaster had an mPCAs concentration of 63 ng/g and butter samples from Ireland, Denmark and Wales had levels of 52, 11 and 8.8 ng/g, respectively.

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