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Toxicological information

Exposure related observations in humans: other data

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Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, non-guideline study, published in peer-reviewed literature, no analytical purity of the tested TAME sample was reported

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

Materials and methods

Type of study / information:
Acute effects after controlled TAME exposure of male volunteers.
Endpoint addressed:
acute toxicity: inhalation
Principles of method if other than guideline:
Six men per group with an average age of 24.2 years were exposed in a 15 m3 exposure chamber to 0, 15 (64 mg/m3) or 50 ppm (212 mg/m3) TAME for 4 hours.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Details on study design:
Six men per group with an average age of 24.2 years were exposed in a 15 m3 exposure chamber to 0, 15 (64 mg/m3) or 50 ppm (212 mg/m3) TAME for 4 hours. The physical activity of the exposed corresponded to light deskwork. Samples from blood and exhaled air were taken before, during and after exposure. In addition, the subjects collected all urine during 48 hours starting from the time before exposure. The exhaled air, blood and urine samples were analysed using headspace gas chromatography. Acute toxic symptoms (sensory irritation and pre-narcotic signs) were recorded
based on subjective reporting. The answers were analysed and four closely related symptom complexes were formed, namely, “irritation”, “feelings in the head”, and “mood”. The questionnaire was filled at one and 3 hours from the start of exposure and one hour post-exposure. Posturography (steadiness of standing) was conducted and reaction time (response to visual signal) measured. The posturographic measurements were conducted
before exposure, at 1, 2.5 and 3.5 hours after start of exposure and 1 hour post-exposure. The reaction time was measured in the morning before
the exposure, at 1 and 3.5 hours after the start of exposure and one hour post-exposure.
Exposure assessment:
measured
Details on exposure:
Exposure was in a 15 m3 exposure chamber to 0, 15 (64 mg/m3) or 50 ppm (212 mg/m3) TAME for 4 hours.

Results and discussion

Results:
The reported symptoms were minimal. Two persons reported slight irritation of the eyes, nose and throat and drying of the mouth. One reported this only with the highest concentration, while the other reported all three irritation symptoms also on the control day. When the symptoms belonging to the complex “feelings in the head” were reported, after one hour of exposure, one person reported slight headache in both 15 and 50 ppm exposure concentrations. After three hours, one person in the 15 ppm group and two persons in the 50 ppm reported slight headache. A symptom described as “heaviness of head” was experienced by 2 persons at 1 hour and by 3 persons at 3 hours. Contrary to expectations, on exposure days, five persons reported no “heaviness of head” at 50 ppm after either 1 or 3 hours after the start of exposure. In 15 ppm exposure, three persons reported no heaviness of head at 1 hour and two at 3 hours. When mood changes were reported, one person at 15 ppm and another at 50 ppm reported negative mood. On control day nobody reported a negative mood.
TAME had no significant effect on mood, reaction time or steadiness of standing.

Any other information on results incl. tables

The reporting on the effects is somewhat inconsistent and not very firm conclusions can be drawn from the study.

Applicant's summary and conclusion