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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
250 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

In a first step, the starting point oral value should be corrected forroute-to-route extrapolation. In accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’), in the absence of data, no default factor should be introduced for oral-to-dermal extrapolation, basedon the assumption that dermal absorption will in general not be higher than oral absorption.However, for highly lipophilic substances (log Kow > 4), according toSection R.7.12.2.1 of REACH guidance document R7.C (May 2008), a 10% default dermal absorption percentage value is recommended in the absence of test data for the purpose of risk assessment.Therefore a factor of 10 (ABSoral/ABSdermal= 100/10) can be used to correct the starting dose for absorption difference between routes.The next steps consist in applyingassessment factors(AF) for interpecies difference, intraspecies variation, exposure duration, dose-response and quality of the database, as presented in Section R.8.4.3 of REACH guidance document R.8. The overall AF in this case corresponds to 200. The resulting DNELlong-term, workers, dermal is equivalent to 250 mg /kg bw/day.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
125 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
400
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

For consumers, a similar procedure is applied as for the derivation of worker DNELs. The only difference is that the assessment factor for intraspecies variation is 10 instead of 5 in this case, according to Section R.8.4.3 of REACH guidance document R.8. The overall AF therefore corresponds to 400. The resulting DNELlong-term, consumers, dermal is equivalent to 125 mg /kg bw/day.