Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
130 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
3
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
958 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
9
Modified dose descriptor starting point:
LOAEC

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:
19 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
12
Modified dose descriptor starting point:
NOAEL
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:
high hazard (no threshold derived)

Additional information - workers

For acute inhalation toxicity (systemic effects), the DNEL of 958 mg/m3 was derived using a LOAEL of 5100 mg/m3 as the starting point. This starting point was chosen as the lowest, most relevant, and most reliable guideline study result suitable to prevent the critical effect of central nervous system depression (sedation). Consistent with Chapter R.8 (May 2008) of the REACH guidanceand with ECETOC Technical Report No. 86 (February 2003), a factor of 0.67 was used to modify the starting point to light work and an overall assessment factor of 9 was used and derived as follows: 1 for exposure duration, 1 for interspecies, 3 for intraspecies, 3 for LOAEL to NOAEL, and 1 for quality of the database. This value was then adjusted from a 4 hour exposure duration to a 15 minute duration using Haber's law where n= 3 and k was determined to be 1.317e10.

For long-term dermal systemic effects, the DNEL of 19 mg/kg bw/day was derived using a NOAEL of 225 mg/kg from a 2-year oral rat study as the starting point. This starting point was chosen as the lowest, most relevant, and most reliable guideline study result to prevent the critical effect of central nervous system depression (sedation). Consistent with Chapter R.8 (May 2008) of the REACH guidance and with ECETOC Technical Report No. 86 (February 2003), no additional adjustment to the starting point was needed and an overall assessment factor of 12 was used and derived as follows: 1 for exposure duration, 4 for interspecies, 3 for intraspecies, and 1 for quality of the database.

For long-term inhalation toxicity (systemic effects), the DNEL of 130 mg/m3 was derived using a NOAEL of 225 mg/kg from a 2-year oral rat study as the starting point. This starting point was chosen as the lowest, most relevant, and most reliable guideline study result to prevent the critical effect of central nervous system depression (sedation). Consistent with Chapter R.8 (May 2008) of the REACH guidanceand with ECETOC Technical Report No. 86 (February 2003), a factor of 1 was used to modify the starting point for absorption from oral to inhalation, 2.6 was used to modify the starting point from oral to 8hr inhalation exposure, and 0.67 was used to modify the starting point to light work, and an overall assessment factor of 3 was used and derived as follows: 1 for exposure duration, 1 for interspecies, 3 for intraspecies, and 1 for quality of the database.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population