Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 236-759-1 | CAS number: 13476-99-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.7 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- LOAEC
- Value:
- 1.9 mg/m³
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 0.955 mg/m³
- Explanation for the modification of the dose descriptor starting point:
corrected LOAEC = 1.9 mg/m3 * (6h/d / 8h/d) * (6.7 m3/10 m3) = 0.955 mg/m3
The dose descriptor starting point is taken from a chronic (2 years) inhalatory study in rats similar to OECD Guideline 453 (NTP 2002): LOAEC = 1.9 mg/m3. This dose descriptor starting point is corrected by taking into account the differences between experimental and human exposure conditions: 8 h exposure/day for workers vs. 6 h exposure/day in the study; standard respiratory volume under light activity for workers vs. standard respiratory volume during 8 h. A corrected dose-descriptor starting point of 0.955 mg/m3 is derived.
- AF for dose response relationship:
- 3
- Justification:
- Default; LOAEC to NAEC
- AF for differences in duration of exposure:
- 1
- Justification:
- Default; chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default; no allometric scaling applied
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
- AF for the quality of the whole database:
- 2
- Justification:
- due to read-across
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 31.8 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor:
- LOAEC
- Value:
- 1.9 mg/m³
- AF for dose response relationship:
- 3
- Justification:
- Default; LOAEC to NAEC
- AF for differences in duration of exposure:
- 1
- Justification:
- Default; chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default; no allometric scaling applied
- AF for other interspecies differences:
- 1
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
- AF for the quality of the whole database:
- 2
- Justification:
- due to read-across
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.8 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- LOAEL
- Value:
- 1.9 mg/m³
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 0.542 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
corrected dermal LOAEL = inhalatory LOAEC * sRVrat (8 h) * (6h/d) / (8h/d)
corrected dermal LOAEL = 1.9 mg/m3 * 0.38 m3/kg bw * 0.75 = 0.542 mg/kg bw
The dose descriptor starting point is taken from a chronic (2 years) inhalatory study in rats similar to OECD Guideline 453 (NTP 2002): LOAEC = 1.9 mg/m3. This dose descriptor starting point is corrected by taking into account the differences between experimental and human exposure conditions: 8 h exposure/day for workers vs. 6 h exposure/day in the study; standard respiratory volume for rats during 8 h. A corrected dose-descriptor starting point of 0.542 mg/kg bw is derived.
- AF for dose response relationship:
- 3
- Justification:
- Default; LOAEC to NAEC
- AF for differences in duration of exposure:
- 1
- Justification:
- Default; chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
- AF for the quality of the whole database:
- 2
- Justification:
- due to read-across
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- low hazard (no threshold derived)
Additional information - workers
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
DNEL related information
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
