Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Additional toxicological data

Currently viewing:

Administrative data

additional toxicological information
Type of information:
other: biological monitoring
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication/report meeting basic scientific principles. Probabilistic modelling of dietary exposure.

Data source

Reference Type:
Dietary exposure to chemical migrants from food contact materials: A probabilistic approach.
Holmes, M.J. et al.
Bibliographic source:
Food Additives and Contaminations 22(10): 907-919

Materials and methods

Type of study / information:
A two-dimensional probabilistic model has been developed to estimate the short-term dietary exposure of UK consumers to migrants from food packaging materials.
Principles of method if other than guideline:
The model implements a two-dimensional Monte Carlo approach to explore the range of exposures the UK population may experience due to the migration of chemicals (including styrene) from packaging materials and calculates the daily dose.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Specific details on test material used for the study:
- Name of test material (as cited in study report): styrene
- Analytical purity: no data

Results and discussion

Any other information on results incl. tables

In a recent study (FSA), 20 main total dietary study food groups were analysed for styrene. The limit of detection/limit of quantification values were 0.3 µg/kg and 1.0 µg/kg, respectively. In this study, the main food groups were used. To each group, the appropriate concentration dataset comprising of 5 data-points per group including non-detects and non-quantifiables were associated. The concentration data were associated on a 100 % market share basis with extrapolation factors and conversion factors set to unity. The simulated the scenario that if a food item in say the carcass meats groups were consumed it would take a sample from a nominal distribution constructed from the 5 data-points contained in the carcass meat concentration data. Using the two-dimensional Monte Carlo approach, the authors simulated the exposures due to the dietary consumption of the individiuals in three surveys.

The study comprised of homogenised samples of foods from each of the main food groups to determine migration levels. However, this means any correlation or contributions between high exposures and particular food items within food groups would be hidden.

In the FSA styrene study (FSA 1999), by multiplying the average consumption (using data from national dietary studies conducted in 1997) of the food groups by the mean level of styrene in each group, the average dietary exposure for a 60 kg individual was estimated. This was in the range, 0.03 -0.05 µg/kg bw/day, significantly less than the Maximum Tolerable Daily Intake of 40 µg/kg bw/day as set by the Joint FAO/WHO commitee. In the above study model, for the adult age group, the 95% confidence range of the median dietary exposure was calculated to be 0.037 -0.041 µg/kg bw/day with the median estimate being 0.039 µg/kg bw/day. This is in total agreement with the FSA findings. With the additional analysis available we can similarly extract estimates for youths and seniors (95% confidence range in square brackets) as 0.048 [0.046; 0.051] µg/kg bw/day, 0.035 [0.033; 0.037] µg/kg bw/day, respectively.

Applicant's summary and conclusion