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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.4 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):
225
Modified dose descriptor starting point:
LOAEC
Value:
88 mg/m³
Explanation for the modification of the dose descriptor starting point:
According to ECHA Guidance example R.8-2
AF for dose response relationship:
3
Justification:
LOAEL to NOAEL extrapolation
AF for differences in duration of exposure:
6
Justification:
subchronic to chronic default factor
AF for interspecies differences (allometric scaling):
1
Justification:
already included in route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
default factor
AF for intraspecies differences:
5
Justification:
default factor for workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The relevant toxicity endpoints for worker risk assessment are skin sensitisation for dermal exposures (qualitative assessment), and systemic toxicity via the inhalation route (quantitative assessment). Due to the skin sensitisation effect, dermal exposures will generally be minimised by RMM, so that a quantitative assessment of acute or repeated dose systemic or local exposures is not relevant. For the sake of simplicity, sytemic exposure via the inhalation route will for all exposure durations be assessed against the long term DNEL.

When deriving the Inhalation DNEL it has been assumed that oral and Inhalation bioavailability are the same. However as indicated in the toxicokinetics section and the summary of repeated dose toxicity data, this substance is estimated to be very poorly absorbed via all routes prior to the reduction of the azo bond. Once this occurs, the metabolites will be significantly more bioavailable via oral and dermal routes. Via inhalation the reduction of the azo bond is considered highly unlikely, consequently, the actual difference in absorption between these two routes (oral and inhalation) is considered to be closer to 100 fold. Therefore due to potential differences in metabolism the oral toxicity studies may not be completely representative of an inhalation hazard (likely an over vast estimate).

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

Concentrations in consumer products (fuel) will be below 0.01%, hence no assessment is warranted