Registration Dossier
Registration Dossier
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EC number: 204-671-2 | CAS number: 124-02-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.23 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 92.56 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Route to route extrapolation required for oral to inhalation route conducted based on the results of an oral OECD 422 study.
The dose descriptor starting point was the NOAEL result of 75 mg/kg bw/day for systemic toxicity, obtained from an oral OECD 422 study.
It is assumed as a worst case assumption that the oral absorption rate is 50% of that of the inhalation absorption.
The corrected dose descriptor (NOAEC) for inhalation was calculated in accordance with the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8: Characterisation of dose [concentration]-response for human health.
The conversion of an oral rat NOAEL into a corrected inhalatory NOAEC to assess human inhalatory exposure was performed using the modification of starting point equation as given in Figure R. 8-3 (see below) for workers (in the case of 8 hour exposure/day).
Default parameters for rats and humans (for 8 hour exposure) were used for the modification of starting point under the allometric scaling principle as given in Table R. 8-2 of the above ECHA guidance.
An additional factor of 1.4 was included in the modification calculation to take into account correction for differences between human and experimental exposure conditions. When correcting an oral NOEAL to inhaltion NOEAC the correction factor for worker population would be : 7 day/week (experimental animal exposure) / 5 days/week (worker exposure conditions) = 1.4. This additional factor is also provided by the IUCLID DNEL calculator tool.
Conversion of an oral rate N(L)OAEL into a correct inhalatory N(L)OAEC to assess human inhalatory exposure:
For workers (in case of 8h exposure/day):
Corrected inhalatory N(L)OAEC = oral N(L)OAEL x (1 / sRVrat) x (ABSoral-rat / ABSinh-human) x (sRVhuman / wRV) x 1.4
Corrected inhalatory N(L)OAEC= 75 mg/kg bw/day x (1 / 0.38 m3/kg/d) x (0.5) x (6.7 m3(8h) / 10 m3(8h)) x 1.4= 92.56 mg/m3
Where:
ABS: Absorption
sRV: standard Respiratory Volume
wRV: worker Respiratory Volume (light activity)
Default parametrs:
sRVrat (8 h) : 0.38m3/kg bw
sRVhuman (8 h) : 6.7 m3/ person
wRV (8 h): 10 m3/ person
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL the default assessment factor is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default AF for subacute to chronic studies
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF for allometric scaling not required as the differences in allometry (respiration rate and rat to human body sizes) were considered in the conversion from oral to inhalation starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- AF for worker population
- AF for the quality of the whole database:
- 1
- Justification:
- None considered applicable.
- AF for remaining uncertainties:
- 1
- Justification:
- None considered applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.35 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 105 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Route to route extrapolation required for oral to dermal route as no long term dermal study available.
The dose descriptor starting point was the NOAEL result of 75 mg/kg bw/day for systemic toxicity, obtained from an oral OECD 422 study.
Modification of this oral result into a dermal starting point was performed.
It is considered that dermal absorption will not be higher than oral absorption, therefore no default factor (i.e. factor 1) should be introduced when performing oral-to dermal extrapolation.
An addition factor of 1.4 was included in the modification calculation to take into account correction for differences between human and experimental exposure conditions. When correcting an oral NOEAL to dermal NOEAL the correction factor for worker population would be : 7 day/week (experimental animal exposure) / 5 days/week (worker exposure conditions) = 1.4.
This additional factor is also provided by the IUCLID DNEL calculator tool.
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL the default assessment factor is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default AF for subacute to chronic studies
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rat.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for worker population
- AF for the quality of the whole database:
- 1
- Justification:
- None considered applicable.
- AF for remaining uncertainties:
- 1
- Justification:
- None considered applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.13 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification of dose descriptor starting point required.
- AF for dose response relationship:
- 1
- Justification:
- When the starting point for the DNEL calculation is a NOAEL the default assessment factor is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default AF for subacuteto chronic studies
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- AF for rat.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general populaiton
- AF for the quality of the whole database:
- 1
- Justification:
- None considered applicable.
- AF for remaining uncertainties:
- 1
- Justification:
- None considered applicable.
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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