Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

health surveillance data
Type of information:
other: health surveillance data from routine checkups
Adequacy of study:
other information
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 Type:
other company data
Report date:

Materials and methods

Study type:
medical monitoring
Endpoint addressed:
repeated dose toxicity: inhalation
GLP compliance:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Test material form:
solid: nanoform, no surface treatment
Details on test material:
- State of aggregation: solid, powder
- Particle size distribution (TEM): 18.0 nm (D50)
- Mass median aerodynamic diameter (MMAD): not specified
- Geometric standard deviation (GSD): not specified
- Shape of particles: spherical
- Surface area of particles: 76 m²/g
- Crystal structure: crystalline
- Coating: no
- Surface properties: not applicable
- Density: 1415 kg/m³ at 20°C
- Moisture content: refer to IUCLID chapter 1
- Residual solvent: refer to IUCLID chapter 1
- Activation: not applicable
- Stabilisation: not applicable
Specific details on test material used for the study:
Pigments of the chemical class Isonindolinone

Pigments of the chemical Class Perylene


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

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