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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 278-928-2 | CAS number: 78491-02-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 12
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 246 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Long-term inhalation toxicity extrapolated from longest available repeat-dose (oral) study. Uncertainty of extrapolation addressed in DNEL calculation.
- Justification:
- Not required: starting point was a NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default, subchronic to chronic
- Justification:
- Allometric scaling not required
- Justification:
- Not required
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC AF
- AF for the quality of the whole database:
- 2
- Justification:
- The quality of the database for this endpoint is adequate for assessment, but the default AF is increased from 1 to 2, recognising that no long-term inhalation toxicity data are available
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 92 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 553 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Available acute inhalation toxicity data inadequate: systemic toxicity evaluated in acute oral studies. Uncertainty of extrapolation addressed in DNEL calculation.
- Justification:
- Not required: starting point was a NOAEC
- Justification:
- Allometric scaling not required
- Justification:
- Not required
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC AF
- AF for the quality of the whole database:
- 2
- Justification:
- The quality of the database for this endpoint is adequate for assessment, but the default AF is increased from 1 to 2, recognising that no acute inhalation toxicity data are available
- Justification:
- Not required
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:
- 11.7 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 280 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Long-term dermal toxicity extrapolated from longest available repeat-dose (oral) study
- Justification:
- Not required: starting point was a NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA guidance: subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA guidance
- Justification:
- Not required
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC AF
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable source study
- Justification:
- Not required
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)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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
General Population - Hazard via dermal route
Systemic 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
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)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance but incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No extrapolation required
- Justification:
- Not required: starting point was a NOAEC
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default, subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA guidance
- Justification:
- Not required
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC AF
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the database for this endpoint is adequate for assessment
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - General Population
No consumer uses for which exposure or risk evaluation are required under REACH are included in this registration; consumer uses are regulated under the Cosmetics Directive (76/768/EEC, as amended). However, oral systemic effects - Long-term DNEL has been derived for use in man via environment exposure assessment.
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.
