Radia 7838

Health surveillance data

Administrative data

Endpoint:

health surveillance data

Type of information:

other: company data

Adequacy of study:

supporting study

Study period:

January 1, 2010 to March 1, 2011

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Reported information from individual medical reecords of company.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Study type:

health record from industry

Endpoint addressed:

skin sensitisation

GLP compliance:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Radiagreen RA

Method

Type of population:

occupational

Ethical approval:

not applicable

Details on study design:

10 Operators and 6 lab technicians work (have worked) with Radiagreen RA, they have an average duration of employment of over 10 years. Exposure is nihil on workplace as reaction takes place in closed batch reactor system. However, peak level exposure takes place when sampling (8 samples/sampling), see separate excel file for this. Operators are exposed 5 min/sample, however should wear gloves, protective glasses and overall. Lab technicians are exposed for 45 min during analysis wearing only protective glasses. Thirthy three sampling times were recorded from December 2005 onwards.

Results and discussion

Results:

In a registration period of 14 months no employees with skin sensitisation were registered or reported during an occupational medical examination period from 1-1-2010 until 1-3-2011. Although actual exposure for operators would be minimal due to conditions (sampling time, RMMs), and for lab technicians this would be minimal due to the handling (analysis), this health record shows that when exposure has taken place this did not result in skin sensitisation.