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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
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:
- 70.528 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Good quality oral study available. While no inhalation exposure anticipated, it is possible to derive systemic NOAEC for this route using default assumptions and the oral data to extrapolate, as per ECHA guidance ("Guidance on information requirements and chemical safety assessment; Chapter R.8: Characterisation of dose [concentration]-response for human health.)
- AF for dose response relationship:
- 1
- Justification:
- Adequate dosing and study information. No justification for deviating from the standard AF outlined in Ch R:8 based on the database.
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- According to Chapter R.8-Dose [Concentration]-Response Regarding Human Health, an additional assessment factor of 2.5 should be applied for remaining differences between test species and human. In cases where differences are not related to basal metabolic rate, the assessment factor should be modified. In terms of dynamics, one might assume that animals and humans will respond in the same way (p. 33). Based on the physicochemical properties, absorption is believed to be limited to such a degree that metabolic differences are not relevant for remaining differences. for more details see systemic dermal DNELs.
- AF for intraspecies differences:
- 5
- Justification:
- Standard default value for workers as indicated by the ECHA guidance document “Guidance on information requirements and chemical safety assessment; Chapter R.8: Characterisation of dose [concentration]-response for human health.
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable study, good quality database
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As a conservative assumption the oral and dermal absorption is considered identical and therefore no modification to the dose descriptor is necessary.
- AF for dose response relationship:
- 1
- Justification:
- Default value in accordance with ECHA guidance- Chapter R.8
- AF for differences in duration of exposure:
- 2
- Justification:
- AF of 2 used for Subchronic to Chronic extrapolation (ECHA guidance- Chapter R.8)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor rat to human = 4 (ECHA guidance- Chapter R.8)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value in accordance with ECHA guidance- Chapter R.8
- AF for intraspecies differences:
- 5
- Justification:
- Intraspecies AF factor of 5 is used for workers (ECHA guidance- Chapter R.8)
- AF for the quality of the whole database:
- 1
- Justification:
- Dataset of sufficient quality, therefore default value of 1.0 used accordance with ECHA guidance- Chapter R.8
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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:
- 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:
- 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:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification required.
- AF for dose response relationship:
- 1
- Justification:
- Default value in accordance with ECHA guidance- Chapter R.8
- AF for differences in duration of exposure:
- 2
- Justification:
- AF of 2 used for Subchronic to Chronic extrapolation (ECHA guidance- Chapter R.8)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor rat to human = 4 (ECHA guidance- Chapter R.8)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value in accordance with ECHA guidance- Chapter R.8
- AF for intraspecies differences:
- 10
- Justification:
- Intraspecies AF factor of 10 is used for general population (ECHA guidance- Chapter R.8)
- AF for the quality of the whole database:
- 1
- Justification:
- Dataset of sufficient quality, therefore default value of 1.0 used accordance with ECHA guidance- Chapter R.8
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No acute hazards were identified for the registration substance.
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
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.
