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EC number: 203-497-4 | CAS number: 107-51-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 78 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 945 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for repeated dose effects via the inhalation route is determined on the basis of the 90-day inhalation study. In this study a NOAEC of 3870 mg/m³ was derived based on adverse effects on the liver. NOAEC: 3870 mg/m³ The following correction was made to the NOAEC: Correction for exposure duration: 6 h/8 h (default for workers). Correction for respiratory rate and volume (human worker): (6.7 m³/d/10 m³/d) (default) Therefore the corrected NOAEC for the inhalation route is: 3870*(6/8)*(6.7 m³/d /10 m³/d) = 1945 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEC was established
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (inhalation route)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Guideline, GLP study
- 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:
- 1 103 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 110 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for repeated dose effects via the dermal route is determined on the basis of route-to-route extrapolation from the 90-day inhalation study. In this study a NOAEC of 3870 mg/m³ was derived based on adverse effects on the liver. The following correction was made to the NOAEC(inhalation) to derive a NOAEL(dermal): Correction for exposure duration: 6h / 8h (default for workers) Correction for respiratory volume: 0.38 m³/kg (default, rat, 8 hour). Therefore, the corrected NOAEL for effects via the dermal route is: 3870*(6/8)*0.38 = 1103 mg/kg bw/day. In practice, the dermal absorption of this substance is very limited. A further correction for the known dermal absorption of 1% has been made, with the additional factor of 100: 1103 mg/kg bw/day x 100 = 110300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEC was established
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Guideline, GLP study
- 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Short-term high exposures are considered unlikely given the high levels of control in place at sites producing and using the substance. DNELs for long-term exposure are therefore adequate to protect against short-term exposures and no separate short-term DNELs are calculated.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 19 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 968 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL for repeated dose effects via the inhalation route is determined on the basis of the 90-day inhalation study. In this study a NOAEC of 3870 mg/m³ was derived based on adverse effects on the liver. NOAEC: 3870 mg/m³ The following correction was made to the LOAEC: Correction for exposure duration: 6/24 (default for consumers) Therefore the corrected NOAEC for effects via the inhalation route is: 3870 mg/m³*(6/24) = 968 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEC was established
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (inhalation route)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Guideline, GLP study
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 556.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 111 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for repeated dose effects via the dermal route is determined on the basis of route-to-route extrapolation from the 90-day inhalation study. In this study a NOAEC of 3870 mg/m3 was derived based on adverse effects on the liver. The following correction was made to the NOAEC(inhalation) to derive a NOAEL(dermal): Correction for exposure duration: 6h / 24h (default for consumers) Correction for respiratory volume: 1.15 m³/kg (default, rat). Therefore the corrected NOAEL for effects via the dermal route is: 3870*(6/24)*1.15 = 1113 mg/kg bw/day. In practice, the dermal absorption for this substance is very limited. A further correction for the known dermal absorption of 1% has been made, with the additional factor of 100: 1113 mg/kg bw/day x 100 = 111300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEC was established
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (sub-chronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Guideline, GLP study
- 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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.04 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL for the oral route is based on the 28-day oral study and no route to route extrapolation is required.
- AF for dose response relationship:
- 1
- Justification:
- A clear NOAEL was established
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- Guideline, GLP study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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.
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.
