Registration Dossier
Registration Dossier
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EC number: 926-564-6 | CAS number: 1179964-22-7
Toxicological Summary
Administrative data
Workers - 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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The hazard assessment will be updated upon finalisation of the experimental testing programme, i.e. OECD 408 and OECD 414.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 1
- AF for the quality of the whole database:
- 1
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)
- Most sensitive endpoint:
- repeated dose toxicity
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Oral data from the rat are used to decide on a corresponding oral dose for humans. Therefore a route-to-route extrapolation is not necessary.
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL calculation is a NOAEL according to ECHA Guidance (November 2012), R.8.4.3.1 the default assessment factor, as a standard procedure, is 1.
- AF for differences in duration of exposure:
- 1
- Justification:
- According to ECHA Guidance (November 2012) Chapter R. 8. Table R.8-5 a default assessment factor of 6 should be used for the difference in the experimental exposure duration (= subacute) and the duration of exposure for the population and scenario under consideration (= chronic). A lower factor (minimum 1) may be used if there is evidence that increasing exposure duration does not increase the incidence or severity of adverse effects. This applies to the local effects seen in the intestine (mainly cecum) of the rat after subacute oral administration.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- It is to be noted that allometric scaling should not be applied if the effects are not dependent on metabolic rate or systemic absorption, e.g. in the case of local effects.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor 2.5 for remaining differences is suggested by the Guidance Document R.8 (ECHA, 2012)
- AF for intraspecies differences:
- 10
- Justification:
- According to ECHA Guidance (November 2012) Chapter R.8.4.3.1 the default AF to be applied for intraspecies differences in General Population is 10. For local effects, the assessment factors to be used for intraspecies differences are the same as those proposed above for systemic effects.
- AF for the quality of the whole database:
- 1
- Justification:
- According to ECHA Guidance (November 2012) R.8.4.3.1 the default AF to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1.
- AF for remaining uncertainties:
- 1
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
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