Registration Dossier
Registration Dossier
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EC number: 203-366-1 | CAS number: 106-14-9
Toxicological Summary
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.
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