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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Epidemiological data

Currently viewing:

Administrative data

epidemiological data
Type of information:
experimental study
Adequacy of study:
supporting study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: basic information given

Data source

Reference Type:
Blood methanol concentrations in normal adult subjects administered abuse doses of aspartame.
Stegink, L.D. et al.
Bibliographic source:
J. Toxicol. Environ. Health 7(2), 281-290

Materials and methods

Endpoint addressed:
basic toxicokinetics
Principles of method if other than guideline:
Blood methanol concentrations were measured in 30 normal adult subjects administered aspartame, a dipeptide methyl ester.

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
methyl L-alpha-aspartylphenylalaninate


Details on study design:
The doses studied included the 99th percentile of projected daily ingestion (34 mg/kg body weight) and three doses considered to be in the abuse range (100, 150, and 200 mg/kg body weight).

Results and discussion

Methanol concentrations were below the Ievel of detection (0.4 mg/dl) in the blood of the 12 normal subjects who ingested aspartame at 34 mg/kg. They were significantly elevated after ingestion of each abuse dose, with the mean peak blood methanol concentrations and the areas under the blood methanol concentration-time curve increasing in proportion to dose. Mean (±SO) peak blood methanol concentrations were 1.27 ± 0.48 mg/dl at the 100 mg/kg dose, 2.14 ± 0.35 mg/dl at the 150 mg/kg dose, and 2.58 ± 0. 78 mg/dl at the 200 mgjkg dose. Blood methanol concentrations returned to predosing Ievels by 8 h after administration of the 100 mg/kg dose. Methanol was still detected in the blood 8 h after the subjects had ingested aspartame at 150 or 200 mg/kg. Blood formate analyses were carried out in the 6 subjects who ingested aspartame at 200 mg/kg, since recent studies indicate that the toxic effects of methanol are due to formale accumulation. No significant increase in blood formate concentrations over predosing concentrations was noted. No changes were noted in any of the blood chemistry profile parameters measured 24 h after aspartame ingestion, compared to values noted before administration. Similarly, no differences were noted in ophthalmologic examinations carried out before and after aspartame loading.

Applicant's summary and conclusion