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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
1 776 mg/kg bw/day
DNEL related information
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 (i.e. factor of 1) 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 9.6 (ABSoral/ABSdermal= 96/10) can be used to correct the starting dose for absorption difference between routes.

The next steps consist in applying assessment 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 50.

The resulting DNELlong-term, workers, dermal is equivalent to 1,776 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:
888 mg/kg bw/day
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, asimilar 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 100.

The resulting DNELlong-term, consumers, dermal is equivalent to 888 mg /kg bw/day.

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