Registration Dossier
Registration Dossier
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EC number: 248-258-5 | CAS number: 27138-31-4
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:
- 8.8 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):
- 114
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for differences in duration of exposure:
- 2
- Justification:
- exposure duration default, sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- inter-specific correction
- AF for remaining uncertainties:
- 0.57
- Justification:
- difference in respiratory volumes
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 35.08 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 57
- Dose descriptor starting point:
- other: acute toxicity study
- Value:
- 2 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- inter-specific correction for meatabolic rate
- AF for intraspecies differences:
- 5
- Justification:
- for worker
- AF for remaining uncertainties:
- 0.57
- Justification:
- difference in respiratory volumes
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
- Modified dose descriptor starting point:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- exposure duration default, sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- inter-specific correction for meataboli rate
- AF for intraspecies differences:
- 5
- Justification:
- intra-species, worker
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 170 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- other: Acute toxicity study LD50
- Value:
- 2 000 mg/kg bw/day
- Modified dose descriptor starting point:
- other: LD50
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for inter-specific effects
- AF for intraspecies differences:
- 5
- Justification:
- intra-specific for worker
- AF for the quality of the whole database:
- 1
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- DNEL (Derived No Effect Level)
- Value:
- 8.69 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):
- 115
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- correction for metabolic rate
- AF for intraspecies differences:
- 10
- Justification:
- inter-species, general population
- AF for remaining uncertainties:
- 1.15
- Justification:
- difference in respiratory volume
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 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):
- 230
- Dose descriptor starting point:
- other: Acute toxicity LD50
- Value:
- 2 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- intra-specific for general population
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:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 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):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 10
- Justification:
- inter-species, general population
- AF for other interspecies differences:
- 4
- Justification:
- allometric scaling from rat to human
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 80 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):
- 25
- Dose descriptor starting point:
- other: Acute toxicity LD50
- Value:
- 2 000 mg/kg bw/day
- Modified dose descriptor starting point:
- other: acute study
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining inter-specific differences
- AF for intraspecies differences:
- 10
- Justification:
- intra-specific for general population
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
- Modified dose descriptor starting point:
- NOAEL
- AF for differences in duration of exposure:
- 2
- Justification:
- sub-chronic to chronic
- AF for other interspecies differences:
- 10
- Justification:
- inter-species, general population
- AF for remaining uncertainties:
- 2.5
- Justification:
- correction for metabolic rate
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 80 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- other: acute study
- Value:
- 2 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining inter-specific differences
- AF for intraspecies differences:
- 10
- Justification:
- intra-specific for general population
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.
