Bis(2-propylheptyl) phthalate

Epidemiological data

Administrative data

Endpoint:

epidemiological data

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Levels of phthalate metabolites in urine among mother–child-pairs – Results from the Duisburg birth cohort study, Germany

Author:

Monika Kasper-Sonnenberg et al.

Year:

2012

Bibliographic source:

International Journal of Hygiene and Environmental Health 215 (2012) 373–382

Materials and methods

Study type:

cross sectional study

Principles of method if other than guideline:

DPHP metabolites (6-OH-Mono-propyl-heptyl phthalate, 6-Oxo-Mono-propyl-heptyl phthalate, and Mono-(2,7-methyl-7-carboxy-heptyl) phthalate) were determined in urine by multidimensional liquid chromatography coupled to tandem mass spectrometry using internal isotope-labeled standards. The LOQ was 0.2µg/L. These metabolites could not be distinguished from the isomeric metabolites that originated from Di-iso-decylphthalate (DIDP).
To prevend "dilution effects", urine samples with creatinine values below 0.3 and above 3g creatinine/L were excluded from further analysis.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-propylheptyl) phthalate

EC Number:

258-469-4

EC Name:

Bis(2-propylheptyl) phthalate

Cas Number:

53306-54-0

Molecular formula:

C28H46O4

IUPAC Name:

1,2-bis(2-propylheptyl) benzene-1,2-dicarboxylate

Method

Type of population:

other: mother-child pairs

Ethical approval:

confirmed and informed consent free of coercion received

Details on study design:

METHOD OF DATA COLLECTION
- Type: Urine samples
- Details: First morning urine samples from 104 mother-child pairs

STUDY PERIOD: October 2007 to February 2009

STUDY POPULATION
- Selection criteria: self-selected (for previous study in 2000) and responded to follow up letter
- Total number of subjects participating in study: 104 mother-child pairs
- Age children: 6.8 years on average
- Age mothers: 39.2 years on average
- Smoker/nonsmoker: identifed via cotinine and 3OH-cotinine concentration in urine

Exposure assessment:

measured

Statistical methods:

For statistical analyses volume-based concentrations of the measured chemicals and sum values of selected metabolites were used. Values below the LOQ were set to ½ of the LOQ for further calculations.

Results and discussion

Results:

Children:
6-OH-Mono-propyl-heptyl phthalate (OH-MiDP): detected in 97% of the samples, Geometric mean: 2.1µg/L (max value: 63.8µg/L)
6-Oxo-Mono-propyl-heptyl phthalate (oxo-MiDP): detected in 95% of the samples, Geometric mean: 0.6µg/L (max value: 19.2µg/L)
Mono-(2,7-methyl-7-carboxy-heptyl) phthalate (cx-MiDP): detected in all samples, Geometric mean: 1.3µg/L (max value 45.3µg/L)

Mothers:
6-OH-Mono-propyl-heptyl phthalate (OH-MiDP): detected in 98% of the samples, Geometric mean: 1.7µg/L (max value 34µg/L)
6-Oxo-Mono-propyl-heptyl phthalate (oxo-MiDP): detected in 89% of the samples, Geometric mean: 0.4µg/L (max value: 15.4µg/L)
Mono-(2,7-methyl-7-carboxy-heptyl) phthalate (cx-MiDP): detected in 95% of the samples, Geometric mean: 0.6µg/L (max value 16.3µg/L)

Applicant's summary and conclusion

Executive summary:

Of the 21 Phthalate metabolites that were measured in the study, 18 could be detected in almoste all urine samples. Of these, the concentration of the metabolites of DIDP and DPHP (measured together) were by far the lowest in mothers and children. The results were comparable to those reported in other studies.