Registration Dossier

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was not based on a Testing Guideline or conducted under the GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Type of study / information:
Site and employee specific industrial hygiene exposure monitoring data.
Endpoint addressed:
not applicable
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Standard practice personal industrial hygiene exposure monitoring.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
As per Vinyl Neodeconoate IUCLID4 Data Set 2007

Method

Ethical approval:
not applicable
Details on study design:
Personal exposure of Movement Operators and Plant Operators to VV 10 (Vinyl Neodeconoate) was determined during road car top loading and during tasks carried out on the VV 10 process Unit. Personal sampling was by low flow pumps and charcoal adsorbent tubes. Concentrations of VV 10 were determined by a Company developed GC method with flame ionization detection. The GC methodology was demonstrated to have a limit of detection of 0.4 mg VV 10/m3 (0.05 ppm).
Exposure assessment:
estimated
Details on exposure:
Initial qualitative assessment of occupational exposure to VV 10 identified road car top loading as the worst case occupational exposure for all tasks involving potential exposure to VV 10. Short term measurments of 18 - 30 minutes were collected for nine road car loading operations. Shift exposures were measured for two plant operators over four separate shifts. The duration of the two plant operators on the VV 10 Process Unit was 18 - 44 minutes.

Results and discussion

Results:
With the exception of one road car top loading operation, all exposures were below the GC method limit of detection. Therefore, the worker exposures were estimated. The calculated high exposure for road car top loading was 7.0 mg/m3 (0.865 ppm) over a 18 - 30 minute sampling duration. The estimated worst case road car loading shift average exposure was 1.8 mg/m3 (0.22 ppm) 8 hour TWA. All exposure measurments for plant operators were below the GC method level of detection. Estimated plant operator exposures ranged up to < 15.0 mg/m3 (1.85 ppm). The estimated worst case plant operator shift average exposure base on the 1.85 ppm value was < 2.0 mg/m3 (0.25 ppm) 8 hour TWA.

Applicant's summary and conclusion

Conclusions:
Based on exposure measurments and worst case estimations workers are exposed below the current Worker Inhalation DNEL for Vinyl Neodeconoateof 0.6 ppm. Therefore plant operational and processing conditions for Vinyl Neodeconoate are safe.
Executive summary:

Plant operational and processing conditions for Vinyl Neodeconaote are safe for workers based on personal inhalation measurments, exposure estimations and the current Worker Inhalation DNEL of 0.6 ppm TWA. Worst case measurments and estimations of exposure to Vinyl Neodecanoate suggest an upper exposure value of 0.25 ppm.