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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:
supporting study
Study period:
1997-2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A well documented report. No GLP

Data source

Reference
Reference Type:
other: ECHA disseminated dossier
Title:
No information
Report Date:
2014

Materials and methods

Results and discussion

Any other information on results incl. tables

Evaluation of peak exposure data for PROCs: 1, 2, 3, 8b, 9 Highest value (mg/m³): 1.87. 90th percentile (mg/m³): 0.9. In the time period 1997-2011, 27 monitoring data have been generated for acute exposure (<15 minutes). Activities were attributed to PROCs 1,2,3,8b and 9. It was not possible to evaluate the data on the basis of separate PROCs as the number of data was not high enough. Therefore, a statistical evaluation has been performed based on the total number of data. As most of the data were below the limit of determination, the half of the limit of determination was used as recommended by DIN EN 689. This was done for the calculation of the 90th percentile. Evaluation of long-term data for PROCs: 1, 2, 3, 15 and PROCs: Highest value (mg/m³): 1.87. 90th percentile (mg/m³): 0.9. In the time period 1997-2011, 36 monitoring data have been generated for shift exposure (8h-time-weighted average, TWA). Activities were attributed to PROCs 1, 2, 3, 8b, 9 and 15. Also here it was not possible to evaluate the data on the basis of individual PROCs as the number of data was not high enough. It was obvious that for PROC1, 2, 3 and 15, exposure data were rather low. Higher exposure was found for filling operations (PROC8b and 9). Therefore, one statistical evaluation has been performed, based on 19 data for PROC1, 2, 3, 15. A second evaluation was performed for PROC8b and 9 based on 17 measured data. As most of the data were below the limit of determination, half of the limit of determination was used as recommended by DIN EN 689. This was performed for the calculation of the 90th percentile. It should be mentioned that data (few cases) with relatively high limit of quantitation were eliminated as outliers prior to statistical evaluation.

Applicant's summary and conclusion