Registration Dossier
Registration Dossier
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EC number: 221-338-7 | CAS number: 3069-40-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.3 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 175 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 308 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects via the inhalation route is determined on the basis of the NOAEL of 175 mg/kg bw/day concluded in the 90-day oral repeated dose toxicity study (BSL Bioservice, 2020), in which no adverse effects were seen up to the highest dose tested. The dose levels were selected on the basis of an OECD 422 screening study.
The following correction was made to the NOAEL(oral) to derive the NOAEC(inhalation): Correction for respiratory rate and volume (rat to human worker): (6.7 m³/d/10 m³/d)*(1/0.38 m³/kg) (default). Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: [175 mg/kg bw/day*(6.7 m³/d /10 m³/d)*(1/0.38 m³/kg)] = 308 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default sub-chronic to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (oral rat to inhalation human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default (worker)
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted according to relevant OECD test guidelines and in compliance with GLP.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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:
- 1.75 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:
- 175 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 175 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects via the dermal route is determined on the basis of the NOAEL of 175 mg/kg bw/day concluded in the 90-day oral repeated dose toxicity study (BSL Bioservice, 2020), in which no adverse effects were seen up to the highest dose tested. The dose levels were selected on the basis of an OECD 422 screening study.
No correction was applied to the oral NOAEL.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (oral rat to dermal human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default (worker)
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- 3.04 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 175 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 152 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects via the inhalation route is determined on the basis of the NOAEL of 175 mg/kg bw/day concluded in the 90-day oral repeated dose toxicity study (BSL Bioservice, 2020), in which no adverse effects were seen up to the highest dose tested. The dose levels were selected on the basis of an OECD 422 screening study.
The following correction was made to the NOAEL(oral) to derive the NOAEC(inhalation): Correction respiratory volume rat (24 hour) 1/1.15 m³/kg bw. Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: [175 mg/kg/day*(1/1.15m³/kg bw)] = 152 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default sub-chronic to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (oral rat to inhalation human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- General population
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted according to relevant OECD test guidelines and in compliance with GLP.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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:
- 0.89 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:
- 175 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 175 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for systemic effects via the oral route is calculated for the general population for the assessment of humans exposed via the environment. The DNEL is determined on the basis of the NOAEL of 175 mg/kg bw/day concluded in the 90-day oral repeated dose toxicity study (BSL Bioservice, 2020), in which no adverse effects were seen up to the highest dose tested. The dose levels were selected on the basis of an OECD 422 screening study.
No correction was applied to the oral NOAEL.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (oral rat to inhalation human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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
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.
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