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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.37 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Value:
27.8 mg/m³
Explanation for the modification of the dose descriptor starting point:
The relative insolubility of the substance means that bioavailability in the test system could only be assured via an oral gavage study.
AF for dose response relationship:
1
Justification:
ECHA absorptionrat oral = absorptionhuman, oral = absorptionhuman, dermal. The dose-response relationship is considered unremarkable.
AF for differences in duration of exposure:
6
Justification:
ECHA: Subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA: respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
AF for other interspecies differences:
1
Justification:
ECHA: There is no evidence for species differences in the general mode of action or kinetics.
AF for intraspecies differences:
5
Justification:
ECHA: Default value for Workers uses
AF for the quality of the whole database:
1
Justification:
ECHA: Quality of database is good
AF for remaining uncertainties:
2.5
Justification:
ECHA Default
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The substance is considered to be a skin sensitizer based on the positive result from a guinea pig maximization test (GPMT). Exposure is anticipated to be negligible due to the exclusively industrial use in closed systems used and the short campaign times.

A general long term systemic DNEL is derived for the purpose of risk assessment, as a way to demonstrate that potential risks are controlled..

The point of departure for the DNEL is the NOEL from the 1-generation reproductive toxicity study in rats (31.6 mg/kg/bw). A route-to route extrapolation was performed according to the following equation for workers from the ECHA Practical Guide 14:

Inhalatory N(L)OAEC= oral N(L)OAEL*(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh.)

This yields a NOECcorr of 31.6mg/kg/d*(1/0.38 m3/kg/d)*0.67*(0.5*1) =

= 31.6 * 2.63 * 0.67 * 0.5

= 27.8 mg/m3

Assessment factor = 75

DNEL Long term systemic inhalation workers = 27.8 mg/m3/ 75

= 0.37 mg/m3

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:
no hazard identified
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

There are no uses intended that are associated with exposure of the general population. Thus, no DNEL are derived for the general population.