Registration Dossier
Registration Dossier
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EC number: 428-100-3 | CAS number: 94239-04-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.687 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 54.41 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
- Overall assessment factor (AF):
- 37.5
- Modified dose descriptor starting point:
- NOAEC
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:
- 0.13 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
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
The DNEL for worker acute inhalation exposure is derived as follows:
Step 1)
Description: Relevant dose-descriptor
Value: NOAEL: 451 ppm = 451 ppm X 165.0883 (MW) = 74454.8233 / 24.45 = 3045.18705 mg/m3
Remark: This is the concentration where no mortality was produced in a 4-hour LC50 rat inhalation study. Effects at this level included clinical observations that resolved within 2-4 days.
Step 2)
Description: Modification of starting point for differences in respiratory volumes
Value: 0.67 (6.7 m3/10 m3)
Remark: A modification was applied to account for the increased respiratory volumes in active workers as compared to individuals at rest per REACH guidance R.8.4.2.
Step 3)
Description: Assessment Factor: Route–to-route extrapolation
Value: 1
Remark: A factor of 1 is appropriate per REACH guidance R.8.4.2 (inhalation to inhalation).
Description: Assessment Factor: Animal-to-man scaling factor (Allometric scaling)
Value: 1
Remark: A factor of 1 is appropriate since the adjusted start point was via mg/m3(inhalation) and thus this assessment factor is not applicable per REACH guidance R.8.4.3.1.
Description: Assessment factor - Interspecies
Value: 2.5
Remark: A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
Description: Assessment factor – Intraspecies
Value: 5
Remark: This is a default assessment factor for workers per REACH Guidance R.8.4.3.1.
Description: Assessment factor – Exposure duration
Value: 1
Remark: Acute to acute.
Description: Assessment factor – Dose response
Value: 3
Remark: A factor of 3 s appropriate since the dose descriptor is a concentration at which reversible clinical observations were produced.
Description: Assessment factor – Quality of database
Value: 1
Remark: A factor of 1 is appropriate because the database is considered to be adequately robust.
Description: DNEL worker acute inhalation
Value: 54.41 mg/m3
Remark: 3045.18705 x 0.67 = 2040.27532/ (1 x 1 x 2.5 x 5 x 1 x 3 x 1) = 54.41 mg/m3
The DNEL for worker long-term dermal exposure is derived as follows:
Step 1)
Description: Relevant dose-descriptor
Value: NOAEL: 15.2 ppm = 15.2 ppm X 165.0883 (MW) = 2509.3422 / 24.45 = 102.6 mg/m3
Remark: This is the concentration where no significant adverse effects were seen in a 28-day rat inhalation study.
Step 2)
Description: Modification of starting point for rat respiratory volume (Allometric scaling)
Value: 0.38 m3/kg bw (rat 8-hour respiratory volume)
Remark: A modification of starting point for rat respiratory volume was applied per REACH guidance R.8.4.2.
Step 3)
Description: Assessment Factor: Route–to-route extrapolation
Value: 1
Remark: A factor of 1 is appropriate per REACH guidance R.8.4.2 (inhalation to dermal).
Description: Assessment Factor: Animal-to-man scaling factor (Allometric scaling)
Value: 4
Remark: A factor of 4 is appropriate since the adjusted start point was via mg/kg per REACH guidance R.8.4.3.1.
Description: Assessment factor - Interspecies
Value: 2.5
Remark: A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
Description: Assessment factor – Intraspecies
Value: 5
Remark: This is a default assessment factor for workers per REACH Guidance R.8.4.3.1.
Description: Assessment factor – Exposure duration
Value: 6
Remark: This is a default assessment factor for a sub-acute study per REACH Guidance R.8.4.3.1.
Description: Assessment factor – Dose response
Value: 1
Remark: A factor of 1 is appropriate since the dose descriptor is a NOAEL.
Description: Assessment factor – Quality of database
Value: 1
Remark: A factor of 1 is appropriate because the database is considered to be adequately robust.
Description: DNEL worker long term dermal
Value: 0.9 mg/kg
Remark: 102.6 x 0.38 / (1 x 4 x 2.5 x 5 x 6 x 1 x 1) = 0.13 mg/kg
The DNEL for worker long-term inhalation exposure is derived as follows:
Step 1)
Description: Relevant dose-descriptor
Value: NOAEL: 15.2 ppm = 15.2 ppm X 165.0883 (MW) = 2509.3422 / 24.45 = 102.6 mg/m3
Remark: This is the concentration where no significant adverse effects were seen in a 28-day rat inhalation study.
Step 2)
Description: Modification of starting point for worker exposure time
Value: 0.75 (6-hr/8-hr)
Remark: A modification of starting point for worker exposure time as compared to animals exposure time was applied per REACH guidance R.8.4.2.
Description: Modification of starting point for differences in respiratory volumes
Value: 0.67 (6.7 m3/10 m3)
Remark: A modification was applied to account for the increased respiratory volumes in active workers as compared to individuals at rest per REACH guidance R.8.4.2.
Step 3)
Description: Assessment Factor: Route–to-route extrapolation
Value: 1
Remark: A factor of 1 is appropriate per REACH guidance R.8.4.2 (inhalation to inhalation).
Description: Assessment Factor: Animal-to-man scaling factor (Allometric scaling)
Value: 1
Remark: A factor of 1 is appropriate since the adjusted start point was via mg/m3 (inhalation) and thus this assessment factor is not applicable per REACH guidance R.8.4.3.1.
Description: Assessment factor - Interspecies
Value: 2.5
Remark: A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
Description: Assessment factor – Intraspecies
Value: 5
Remark: This is a default assessment factor for workers per REACH Guidance R.8.4.3.1.
Description: Assessment factor – Exposure duration
Value: 6
Remark: This is a default assessment factor for a sub-acute study per REACH Guidance R.8.4.3.1.
Description: Assessment factor – Dose response
Value: 1
Remark: A factor of 1 is appropriate since the dose descriptor is a NOAEL.
Description: Assessment factor – Quality of database
Value: 1
Remark: A factor of 1 is appropriate because the database is considered to be adequately robust.
Description: DNEL worker long term inhalation
Value: 0.687 mg/m3
Remark: 102.6 X 0.75 x 0.67 / (1 x 1 x 2.5 x 5 x 6 x 1 x 1) = 0.687 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
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:
- 1.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
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 DNEL for general population long-term inhalation exposure is derived as follows:
Step 1)
Description: Relevant dose-descriptor
Value: NOAEL: 15.2 ppm = 15.2 ppm X 165.0883 (MW) = 2509.3422 / 24.45 = 102.6 mg/m3
Remark: This is the concentration where no significant adverse effects were seen in a 28-day rat inhalation study.
Step 2)
Description: Modification of starting point for general population exposure time
Value: 0.25 (6-hr/24-hr)
Remark: A modification of starting point for general population exposure time as compared to animals exposure time was applied per REACH guidance R.8.4.2. – p. 27
Step 3)
Description: Assessment Factor: Route–to-route extrapolation
Value: 1
Remark: A factor of 1 is appropriate per REACH guidance R.8.4.2 (inhalation to inhalation).
Description: Assessment Factor: Animal-to-man scaling factor (Allometric scaling)
Value: 1
Remark: A factor of 1 is appropriate since the adjusted start point was via mg/m3(inhalation) and thus this assessment factor is not applicable per REACH guidance R.8.4.3.1.
Description: Assessment factor - Interspecies
Value: 2.5
Remark: A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
Description: Assessment factor – Intraspecies
Value: 10
Remark: This is a default assessment factor for general population per REACH Guidance R.8.4.3.1.
Description: Assessment factor – Exposure duration
Value: 6
Remark: This is a default assessment factor for a sub-acute study per REACH Guidance R.8.4.3.1.
Description: Assessment factor – Dose response
Value: 1
Remark: A factor of 1 is appropriate since the dose descriptor is a NOAEL.
Description: Assessment factor – Quality of database
Value: 1
Remark: A factor of 1 is appropriate because the database is considered to be adequately robust.
Description: DNEL general population long term inhalation
Value: 0.17 mg/m3
Remark: 102.6 x 0.25/ (1x1x2.5x10x6x1x1) = 0.17 mg/m3
The DNEL for general population long-term oral exposure is derived as follows:
Step 1)
Description: Relevant dose-descriptor
Value: NOAEL: 218.8 mg/kg/day
Remark: This is the concentration where no significant adverse effects were seen in a 90-day rat inhalation study.
Step 2)
Description: Assessment Factor: Route–to-route extrapolation
Value: 1
Remark: A factor of 1 is appropriate per REACH guidance R.8.4.2 (oral to oral).
Description: Assessment Factor: Animal-to-man scaling factor (Allometric scaling)
Value: 4
Remark: A factor of 4 is appropriate since the adjusted start point was via mg/kg per REACH guidance R.8.4.3.1.
Description: Assessment factor - Interspecies
Value: 2.5
Remark: A default factor of 2.5 is appropriate per REACH guidance R.8.4.3.1.
Description: Assessment factor – Intraspecies
Value: 10
Remark: This is a default assessment factor for general population per REACH Guidance R.8.4.3.1.
Description: Assessment factor – Exposure duration
Value: 2
Remark: This is a default assessment factor for a sub-chronic study per REACH Guidance R.8.4.3.1.
Description: Assessment factor – Dose response
Value: 1
Remark: A factor of 1 is appropriate since the dose descriptor is a NOAEL.
Description: Assessment factor – Quality of database
Value: 1
Remark: A factor of 1 is appropriate because the database is considered to be adequately robust.
Description: DNEL general population long term oral
Value: 1.1 mg/kg
Remark: 218.8 / (1 x 4 x 2.5 x 10 x 2 x 1 x 1) = 218.8/200 = 1.1 mg/kg
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