Registration Dossier

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.

Applicant's summary and conclusion