Registration Dossier
Registration Dossier
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EC number: 820-225-5 | CAS number: 101747-77-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 247 µg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 37 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Oral rat systemic NOAEL of 30 mg/kg bw derived for developmental toxicity in a study similar to OECD TG 421 (Nemec, 1995) served as the starting point for the DNEL derivation. The NOAEL was converted into inhalatory NOAEC by using the default respiratory volume for rats (8 h), assuming 50% absorption by oral route and 100% absorption by inhalation route (default procedure in case of oral-to-inhalation extrapolation). The NOAEC is additionally corrected by a factor of 1.4 to account for differences in exposure conditions (5 days/week for workers and 7 days for week for animals in the test).
corrected NOAEC = 30 mg/kg bw/d / 0.38 m3/kg bw * (6.7 m3/d / 10 m3/d) * 1.4 / (100% / 50%) = 37.03 mg/m3
- Justification:
- default, NOAEL is used as starting point
- Justification:
- default for subacute to chronic
- Justification:
- already regarded by deriving a corrected NOAEC
- Justification:
- default for remaining interspecies differences
- Justification:
- default for workers
- Justification:
- due to read-across
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:
- 70 µg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 42 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
It is assumed, that the dermal absorption will not be higher than the oral absorption (ECHA's Guidance R.8, v2.1, Nov 2012). Therefore, the NOAEL obtained via the oral route is regarded as a worst-case staring point to determine the dermal DNEL. This NOAEL is corrected by a factor of 1.4 to account for differences in exposure conditions (5 days/week for workers and 7 days for week for animals in the test).
30 mg/kg bw/day * 1.4 = 42 mg/kg bw/day
- Justification:
- default, starting point is a NOAEL
- Justification:
- default for subacute to chronic
- Justification:
- default for rat to human
- Justification:
- default
- Justification:
- default for workers
- Justification:
- due to read-across
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:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 43 µg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 13 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Oral rat systemic NOAEL of 30 mg/kg bw from a study similar to OECD TG 421 for developmental toxicity (Nemec 1995) served as the starting point for the DNEL derivation. The NOAEL was converted into inhalatory NOAEC by using the default respiratory volume for rats (24 h), assuming 50% absorption by oral route and 100% absorption by inhalation route (default procedure in case of oral-to-inhalation extrapolation).
corrected NOAEC = 30 mg/kg bw/d / 1.15 m3/kg bw / (100 % / 50 %) = 13.04 mg/m3
- Justification:
- default, NOAEL is used as starting point
- Justification:
- default for subacute to chronic
- Justification:
- already regarded by deriving a corrected NOAEC
- Justification:
- default for remaining interspecies differences
- Justification:
- default for general population
- Justification:
- due to read-across
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:
- DNEL (Derived No Effect Level)
- Value:
- 25 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
It is assumed, that the dermal absorption will not be higher than the oral absorption (ECHA's Guidance R.8, v2.1, Nov 2012). Therefore, the NOAEL obtained via the oral route is regarded as a worst-case starting point to determine the dermal DNEL.
- Justification:
- default, starting point is a NOAEL
- Justification:
- default for subacute to chronic
- Justification:
- default for rat to human
- Justification:
- default
- Justification:
- default for general population
- Justification:
- due to read-across
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)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
It is assumed, that the oral absorption in human will not be higher than the oral absorption in rats. Therefore, the NOAEL of 30 mg/kg bw obtained in a study similar to OECD TG 421 via the oral route (Nemec 1995) is regarded as a starting point to determine the oral DNEL.
- Justification:
- default, starting point is a NOAEL
- Justification:
- default for subacute to chronic
- Justification:
- default for rat to human
- Justification:
- default
- Justification:
- default for general population
- Justification:
- due to read-across
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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