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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
Toxicological Summary
Administrative data
Workers - 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
Workers - 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:
- DNEL (Derived No Effect Level)
- Value:
- 1 027 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor:
- other: EC3 value
- AF for dose response relationship:
- 3
- Justification:
- Human exposure is expected in a matrix with no penetration enhancers or irritants.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Sensitisation is a local immunological effect with a similar mechanism across mammalian species.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers because no difference in sensitisation potential is expected between workers and consumers.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 027 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor starting point:
- other: EC3 value
- AF for dose response relationship:
- 3
- Justification:
- Human exposure is expected in a matrix with no penetration enhancers or irritants.
- AF for other interspecies differences:
- 1
- Justification:
- Sensitisation is a local immunological effect with a similar mechanism across mammalian species.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers because no difference in sensitisation potential is expected between workers and consumers.
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The substance is not acutely toxic via the oral or dermal routes (LD50 > 2000 mg/kg) and oral administration of test item to rats by gavage, at dose levels of 250, 500 and 750 mg/kg bw/day, was well tolerated in a 90-day repeated dose oral toxicity study (NOAEL 750 mg/kg bw/day). No evidence of skin irritation/corrosion or serious eye damage/irritation was identified but the substance is classified as a skin sensitiser (1B) and appropriate local DNELs have been derived.
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:
- DNEL (Derived No Effect Level)
- Value:
- 1 027 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor:
- other: EC3 value
- AF for dose response relationship:
- 3
- Justification:
- Human exposure is expected in a matrix with no penetration enhancers or irritants.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Sensitisation is a local immunological effect with a similar mechanism across mammalian species.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers because no difference in sensitisation potential is expected between workers and consumers.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 027 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor starting point:
- other: EC3 value
- AF for dose response relationship:
- 3
- Justification:
- Human exposure is expected in a matrix with no penetration enhancers or irritants.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Sensitisation is a local immunological effect with a similar mechanism across mammalian species.
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers because no difference in sensitisation potential is expected between workers and consumers.
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
The substance is not acutely toxic via the oral or dermal routes (LD50 > 2000 mg/kg) and oral administration of test item to rats by gavage, at dose levels of 250, 500 and 750 mg/kg bw/day, was well tolerated in a 90-day repeated dose oral toxicity study (NOAEL 750 mg/kg bw/day). No evidence of skin irritation/corrosion or serious eye damage/irritation was identified but the substance is classified as a skin sensitiser (1B) and appropriate local DNELs have been derived.
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.
