Registration Dossier

Administrative data

Endpoint:
health surveillance data
Type of information:
other: health surveillance data from routine checkups
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Report Date:
2019

Materials and methods

Study type:
medical monitoring
Endpoint addressed:
repeated dose toxicity: inhalation
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Pigments of the chemical class Isonindolinone

Pigments of the chemical Class Perylene

Method

Type of population:
other: worker
Ethical approval:
not applicable
Details on study design:
The company offers routine health checkups for all employees. Within the last 20 years more than 200 worker operating at this pigment production site have been checked. In summary more than 2000 single checkups were performed.
A routine health checkup includes examination of eye-sight, pulmonary function, hearing and general parameters:
- test for acuteness of vision
- spirometrie
- audiometry
- body weight
- blood pressure
- hemogram
- urinalysis

Results and discussion

Results:
In the cause of the employment medical examination within the last years, no need for an occupational health specific action arised.
Additionally, there was also no event which provoked an adaption of the existing safety precausions.

Applicant's summary and conclusion