Registration Dossier

Administrative data

Endpoint:
monitoring data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2010-11-10 to 2011-01-26
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study documentation sufficient (short report), meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Principles of method if other than guideline:
Determination of concentration of decamethylenediamine in air by using recognized and certificated methods (e.g. BIA 2672)
GLP compliance:
not specified
Type of measurement:
other: Concentration in air during cleaining- and maintenance work as well as sampling, transfer and filling procedures at construction site and control center
Media:
air

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solidified melt
Details on test material:
no data

Study design

Details on sampling:
- Personal exposure measurements:
A proband was equipped with a personal-air-sampler pumping a defined volume of air over a sampler (adsorber) during working time. These personally samples were taken at breathing level. An additional blind test was conducted.
- Fixed point measurements:
The sampler was arranged in breathing level at workshop near the proband pumping a defined volume of air over a sampler (adsorber).

Results and discussion

Concentrationopen allclose all
Country:
Germany
Location:
plant
Substance or metabolite:
substance
Conc.:
ca. 5.207 mg/m³ air
Remarks on result:
other: All samples taken at breathing level during mixing and working procedures were shown not to exceed 5.21 mg/m3 of the substance in air.
Country:
Germany
Location:
control center
Substance or metabolite:
substance
Conc.:
< 2.53 mg/m³ air
Remarks on result:
other: All samples taken at breathing level during working procedures were shown not to exceed 2.53 mg/m3 of the substance in air.

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, all samples taken at breathing level at the plant and the control center were shown not to exceed 5.21 mg/m3 of decamthylenediamine in air.
Executive summary:

Concentration of decamethylenediamine in air during cleaning- and maintenance work, sampling, transfer and filling procedures were determined at the plant and the control center by Infracor GmbH.

Six personally samples (2 operators on 2 days) at breathing level were collected over a period of max. 470 min and analysed regarding decamethylenediamine by using recognized and certificated methods.

All samples taken at breathing level in the control center were shown not to ecxeed 2.53 mg/m3 of decamtehylenediamine in air. All samples taken during cleaning- and maintenance work as well as during sampling and filling procedures at the plant did not exceed 5.21 mg/m3 of the substance in air.