Registration Dossier
Registration Dossier
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EC number: 246-874-9 | CAS number: 25340-17-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 4.5
- Dose descriptor starting point:
- NOAEC
- Value:
- 190 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 95.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
See discussion below.
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:
- DNEL (Derived No Effect Level)
- Value:
- 22 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- Overall assessment factor (AF):
- 18
- Dose descriptor starting point:
- NOAEC
- Value:
- 190 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 394 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
See discussion below.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
No acute exposure scenarios are envisaged for this substance and as such there is no requirement to calculate Acute/short term systemic or local DNELs, as the substance is also not classified for acute toxicity.
Chronic, Systemic, Inhalation DNEL
The starting point for the calculation of the systemic, long term exposure DNEL is the NOAEC taken from the 3 month inhalation study of 190 mg/m3
The assessment factors chosen to convert this dose to a worker DNEL are as follows:
Allometric scaling - not needed as starting point is inhalation dose.
'Additional uncertainty' in allometric scaling - 1 - Recent research indicated that the factor of 2.5 is not justified in the majority of cases. In this particular case, there is little evidence that effects observed in the rat study were influenced by non-allometric factors.
Worker variability - 3 (Based on ECETOC guidance)
Time Extrapolation - 1.5 (Based on Recent publication by Batke et al. 2010 and ECETOC guidance)
Total Assessment Factor = 4.5
Starting point for DNEL derivation is 3-month rat inhalation study NOAEC of 190 mg/m3
Conversion to Human LOAEC =190 * 6/8 * 6.7/10
= 95.5 mg/m3
Application of AF leads to an inhalation DNEL (worker) of 21.2 mg/m3
Chronic, systemic, Worker Dermal DNEL
The starting point for the long-term, systemic Dermal DNEL is the 13 week inhalation study NOEL of 190 mg/m3
In the summary of toxicokinetic properties of this substance it is indicated that the rate of absorption through the gut is far greater than the rate through the skin; It is estimated that a maximum of approximately 10% of the material would be expected to pass through the skin following dermal exposure. Inhalation exposure is expected to lead to 100% absorption and therefore a factor of 10 will be used to convert from inhalation to dermal exposure to account for differences in bioavailablity.
Extrapolation from inhalation dose to dermal dose:
Systemic dose from rat study = 190 mg/m3 * 0.29 m3/kg bw = 55.1 mg/kgbw for 5 days per week
Convert 5 day to 7 day = 55.1 * 5/7 = 39.4 mg/kg bw/day
Taking into account dermal penetration of 10% = 39.4 * 10 = 394 mg/kg bw/day
The assessment factors for extrapolating to a DNEL are as follows:
Allometric scaling - 4 (rat to man)
'Other differences' - 1 - Recent research indicated that the factor of 2.5 is not justified in the majority of cases. In this particular case, there is little evidence that effects observed in the rat study were influenced by non-allometric factors.
Worker variability - 3 (based on the recent ECETOC guidance)
Time extrapolation - 1.5 (Based on Recent publication by Batke et al. 2010 and ECETOC guidance)
Quality of the database - 1 (the data are consistent and sufficient to conclude on a safe human level of exposure)
Total assesment factor - 18
Dermal DNEL (long term, systemic) = 394 / 18 = 22 mg/kg bw/day
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
There are no exposure scenarios leading to consumer exposure to this substance, therefore general population DNELs set as no hazard identified.
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