Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 480-880-4 | CAS number: 608-23-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.73 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 83.3 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 205 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to REACH guidance R.8, the NOAEL of 83.33 mg/kg bw/day corresponds to a workplace NAEC of 205 mg/m³:
It is assumed, that inhalation absorption is comparable to oral absorption.
Procedure a) 83.33 mg/kg bw/day : 4 (allometric scaling) x 70 kg bw (body weight human) : 10 m3 (human respiratory volume per 8 h shift) x 7/5 (7 days/week exposure in key study to 5 days working week) = 204.16 mg/m³
Procedure b) 83.33 mg/kg x d : 0.38 m³/kg bw (8 h respiratory volume, rat) x 6.7/10 (correction to human respiratory volume per 8 h shift) x 7/5 (7 days/week exposure in key study to 5 days working week) = 205.69 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation factor from subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already considered in route-to-route extrapolation
- 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:
- 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:
- 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:
- medium hazard (no threshold derived)
DNEL related information
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- 483.3 µg/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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 83.3 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 72.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
According to REACH guidance R.8, the NOAEL of 83.3 mg/kg bw/day corresponds to a NAEC of 72.5 mg/m³
It is assumed, that inhalation absorption is comparable to oral absorption.
Procedure a) 83.3 mg/kg bw/day : 4 (allometric scaling) x 70 kg bw (body weight human) : 20 m³ (daily human respiratory volume) = 72.89 mg/m³
Procedure b) 83.3 mg/kg bw/d : 1.15 m3/kg bw (24 h respiratory volume, rat) = 72.43 mg/m³
Exposure in key study was on 7 days/week
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- Default for extrapolation factor from subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already considered in route-to-route extrapolation
- 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:
- 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:
- 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:
- 139 µg/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
- Dose descriptor starting point:
- NOAEL
- Value:
- 83.3 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 83.3 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 6
- Justification:
- Default for extrapolation from subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor of 4 from rat to humans
- 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:
- 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
There is no direct consumer exposure, only a potential exposure via the environment has to be considered.
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.
