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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 812-713-1 | CAS number: 1219458-12-4
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 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):
- 225
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 17.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Starting point is an OECD 422 study in rat by oral route which establishing a LOAEL of 10 mg/kg bw/day. Corrected inhalation LOAEC = oral LOAELrat (10 mg/kg) * 1/0.38 * 6.7/10 = 17.6 mg/m3. No factor 2 route extrapolation from oral to inhalation. Due to low vapour pressure (4.7 x 10-5 Pa at 20°C), relevant exposure is only possible as aerosol (no fine spraying, only larger droplets). Droplets will deposit mainly on upper airways, and will be subsequently swallowed following mucociliary transportation to pharynx. This results to no principal difference in absorption compared oral route.
- AF for dose response relationship:
- 3
- Justification:
- For LOAEL to NOAEL. There are no further specific concerns. Effects at LOAEL are not severe nand mostly of local nature, and possibly represent a porte d’entrée related effect due to the route of application, and not a systemic effect per se.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default sub-acute to sub-chronic (AF 3) and sub-chronic to to chronic (AF 2). This is a conservative approach considering that specifically the females are exposed for about 50 days in this study, considerably longer than 28, a factor 2 rather than 3 can be used for sub-acute (28-day) to sub-chronic (90-day) extrapolation. A lower factor could be considered on the basis of the understanding that the dose levels of the NOAEL for this effect of foamy macrophages in mesenteric lymph nodes is not influenced by the duration of the study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required for inhalation since this is already accounted for when obtaining the corrected NOEC
- AF for other interspecies differences:
- 2.5
- Justification:
- Default remaining factor
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Based on good quality and consistent data. Available data derived from valid studies showing consistent results within category.
- AF for remaining uncertainties:
- 1
- Justification:
- No major remaining uncertainties. As based on basic data, the default AFs have been applied in full.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.011 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):
- 900
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Starting point is an OECD 422 study in rat by oral route which establishing a LOAEL of 10 mg/kg bw/day.
- AF for dose response relationship:
- 3
- Justification:
- For LOAEL to NOAEL. There are no further specific concerns. Effects at LOAEL are not severe nand mostly of local nature, and possibly represent a porte d’entrée related effect due to the route of application, and not a systemic effect per se.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default sub-acute to sub-chronic (AF 3) and sub-chronic to to chronic (AF 2). This is a conservative approach considering that specifically the females are exposed for about 50 days in this study, considerably longer than 28, a factor 2 rather than 3 can be used for sub-acute (28-day) to sub-chronic (90-day) extrapolation. A lower factor could be considered on the basis of the understanding that the dose levels of the NOAEL for this effect of foamy macrophages in mesenteric lymph nodes is not influenced by the duration of the study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor for allometric scaling from rat to human.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default remaining factor.
- AF for intraspecies differences:
- 5
- Justification:
- Default for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Based on good quality and consistent data. Available data derived from valid studies showing consistent results within category
- AF for remaining uncertainties:
- 1
- Justification:
- No major remaining uncertainties. As based on basic data, the defaults AFs have been applied in full.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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
No exposures. Substance is on-site isolated intermediate, handled under SCC. DNELs therefore do not have to be established.
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:
- no hazard identified
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
No consumer exposures and no relevant indirect exposures from environmental distribution.
Substance is on-site isolated intermediate, handled under SCC.
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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