Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
42.93 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
37.5
Dose descriptor:
other: LOAEL = 1.61mg/cm2 (derived from EC3 value from skin sensitization)
AF for dose response relationship:
3
Justification:
starting value is EC3 which is equivalent to LOAEL
AF for differences in duration of exposure:
1
Justification:
the test time corresponds to the methodology
AF for interspecies differences (allometric scaling):
1
Justification:
local effect, no allometric scaling is needed
AF for other interspecies differences:
2.5
Justification:
default value based on unspecified uncertanities resulting from differencies between animals and humans
AF for intraspecies differences:
5
Justification:
AF for workers
AF for the quality of the whole database:
1
Justification:
the point is based on well documented study with guideline carried out according to GLP principles
AF for remaining uncertainties:
1
Justification:
there are no known uncertanities, including skin sensitisation specific factors: AF for vehicle and matrix effect and AF for different exposure conditions
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.47 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor:
other: LOAEL = 1.61mg/cm2 (derived from EC3 value from skin sensitization)
AF for dose response relationship:
3
Justification:
starting value is EC3 which is equivalent to LOAEL
AF for differences in duration of exposure:
1
Justification:
the test time corresponds to the methodology
AF for interspecies differences (allometric scaling):
1
Justification:
local effect, no allometric scaling is needed
AF for other interspecies differences:
2.5
Justification:
default value based on unspecified uncertanities resulting from differencies between animals and humans
AF for intraspecies differences:
10
Justification:
AF for general population
AF for the quality of the whole database:
1
Justification:
the point is based on well documented study with guideline carried out according to GLP principles
AF for remaining uncertainties:
1
Justification:
there are no known uncertanities, including skin sensitisation specific factors: AF for vehicle and matrix effect and AF for different exposure conditions
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population