Registration Dossier

Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Currently viewing:

Administrative data

direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference Type:
study report
Report date:

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
repeated dose toxicity: inhalation
Principles of method if other than guideline:
Toxic effects in volunteers exposed to DMAC vapour were assessed.
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Test material form:
Specific details on test material used for the study:
- Name of test material: dimethylacetamide (DMAC)
- Source: Satterfield, Textile Company
- Purity: 99.9 %
- Impurities: dimethylformamide (547 ppm), acidity (429 ppm), water (18 ppm), dimethylamine (6 ppm)
No further details available.


Type of population:
- Number of subjects exposed: Laboratory staff, 8 persons
- Sex: male
- Age: 20-32 years old
- Body weight: 75 kg (mean)
Ethical approval:
not specified
Route of exposure:
Reason of exposure:
Exposure assessment:
Details on exposure:
Whole body (dressed in light clothes) exposure was performed in a chamber (1250 cub.ft.); generated test substance vapour (at 75 °C) was diluted with air; air samples were collected prior to and every half-hour during the exposure periods each day; analysis: gas chromatograph coupled with a flame ionization detector.
Exposure: 6 h per day for 5 consecutive days; 1 h dinner period after 3 h exposure.
Analytical concentration: 10.3 ± 1.88 ppm V/V in air (mean ± SD; 5-day overall); range of daily means was 8.6-12 ppm.
Behaviour during and after exposure, porphyrin excretion in urine (24-hour urine samples collected on 5 successive days) and urine analysis (appearance, specific gravity, pH, protein); blood sampling before and after the 5-day exposure period for hematology (red cell count, white cell count, hemoglobin, hematocrit, sedimentation rate, white cell differential count which included counts of adult neutrophils, juvenile neutrophils, eosinophils, basophils, lymphocytes, atypical lymphocytes, and monocytes) and clinical chemistry (total protein, albumin, calcium, cholesterol, glucose, blood urea nitrogen, uric acid, creatinine, total bilirubin, alkaline phosphatase, lactic dehydrogenase, serum glutamic-oxalacetic transaminase, and the albumin/globulin ratio)

Results and discussion

Results of examinations:
Porphyrin excretion in urine was within the normal range of adult males.
All pre- and post-exposure values on all subjects concerning hematology, clinical chemistry and urinalysis parameters were within normal limits as defined by the laboratory performing the study.
Outcome of incidence:
Not applicable

Applicant's summary and conclusion

In a clinical study with 8 male volunteers no toxic effects were reported after repeated inhalation exposure to 10 ppm (36 mg/m³).
Executive summary:

In a repetetive human exposure study 8 male volunteers (20 -32 years) inhaled DMAC at a rate of 6 h/d on 5 consecutive days.

The substance was evaporated in a chamber and the volunteers were exposed in a whole body approach of a test substance concentration of 10.3 ± 1.88 ppm (mean ± SD; 5-day overall).

Measured parameters were behaviour, porphyrin excretion in urine (24-h samples every day), urine analysis, blood sampling (before and after study period) for hematology and clinical chemistry.

The study resulted in a porphyrin excretion of a normal human range and pre- and post-exposure values for hematology, clinical chemistry and urin analysis within normal limits.

In this clinical study with 8 male volunteers no toxic effects were reported after repeated inhalation exposure to 10 ppm (36 mg/m³).