Registration Dossier
Registration Dossier
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EC number: 202-509-5 | CAS number: 96-48-0
Toxicological Summary
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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