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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 254-372-6 | CAS number: 39236-46-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 24.5 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):
- 20
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 490 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.
- AF for dose response relationship:
- 1
- Justification:
- 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):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 1
- Justification:
- Not required, effects concerned stomac lesions possibly due to local irritation of the stomac tissue
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default for workers
- 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 for the registered substance are available
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 45.5 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- other: LD50
- Value:
- 9 100 mg/m³
- AF for dose response relationship:
- 10
- Justification:
- Extrapolation from LD50 to NOAEC
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required
- AF for other interspecies differences:
- 1
- Justification:
- Not applicable
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default value
- AF for the quality of the whole database:
- 2
- Justification:
- Source is an oral study of moderate reliability supported by acute inhalation studies of low reliability.
- AF for remaining uncertainties:
- 2
- Justification:
- Additional uncertainty due to route to route extrapolation.
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:
- 2.8 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):
- 100
- 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
- AF for dose response relationship:
- 1
- Justification:
- 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
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA guidance
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable source study
- AF for remaining uncertainties:
- 1
- Justification:
- Not required
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 160 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- other: LC0
- Value:
- 8 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- LC0
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA guidance
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA guidance for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Not relevant
- AF for remaining uncertainties:
- 1
- Justification:
- Not relevant
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.4 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 280 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAEL is 200 mg/kg based on the analogue: 1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea. Comparing the difference in molecular weight a factor of 1.4 should be applied resulting in a NOEL of 280 mg/kg.
- AF for dose response relationship:
- 1
- Justification:
- starting point is 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
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA guidance
- AF for intraspecies differences:
- 10
- 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:
- No further uncertainties
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, the oral systemic effects, long-term DNEL has been derived for 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.
