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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:
experimental study
Adequacy of study:
weight of evidence
Study period:
Personal monitoring data from June 12, July 17, and September 13, 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
These experiments were not performed under Good Laboratory Practice standards. The data were, however, generated using the U.S. Occupational Safety and Health Administrations modified Organic Method No. 65. Standard operating procedures were followed throughout the study from preparation, sampling, shipping samples, sample analysis, and data retention. Therefore, the data are well documented and scientifically acceptable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Type of study / information:
Personal monitoring data
Endpoint addressed:
not applicable
Test guideline
Qualifier:
according to
Guideline:
other: Modified O.S.H.A. Organic Method No. 65
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diethyltoluenediamine; DETDA

Method

Ethical approval:
not applicable
Details on study design:
Two employees from the plant where DETDA is manufactured wore personal air sampling pumps while performing their duties for either one or two working days.

Employee #1 wore the pump for 450 minutes for 1 day.

Employee #2 wore the pump for 411 and 420 minutes on days 1 and 2, respectively.

The pumps drew a known volume of air through an acid-treated filter to trap basic organic vapors present. At the completion of each monitoring period, the filters were transferrred to small, stoppered sample containers. The analyte was released with dilute NaOH and extracted with toluene. An aliquot of the toluene extract was injected into a gas chromatograph using nitrogen/phosphorus detection, and the area of the sampling peak was determined and compared with areas obtained for standards.

A quality assured standard operating procedure and study protocol based on OSHA’s modified Organic Method No. 65 were employed, which described the principles of the method, range and sensitivity, interferences, precision and accuracy, apparatus and reagents, analysis procedure, collection and shipping of samples, analysis of samples, determination of extraction efficiency, calibrations and standards, and calculations.
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: Personal monitoring


TYPE OF EXPOSURE MEASUREMENT: Personal sampling


EXPOSURE PERIOD: Employees were monitored over the course of one or two working days for a period ranging from 411 to 450 minutes on each day.


DESCRIPTION / DELINEATION OF EXPOSURE GROUPS / CATEGORIES: The employees were involved in the manufacture of DETDA at Albemarle Corporation's Pasadena Plant (2500 N. South Street, Pasadena Texas, U.S.A.).

Results and discussion

Results:
Personal monitoring of employees involved in the manufacture of DETDA demonstrated over a one- or two-day period that no detectable exposures occurred when the employees were monitored from 411 to 450 minutes on each day.

Applicant's summary and conclusion

Conclusions:
These data demonstrate that exposures to DETDA under manufacturing conditions are below the analytical detection limit of <2 micrograms/m3.