Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 469-110-8 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.8 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Additional information - workers
AD-1000 is not classified for acute oral, dermal and inhalation toxicity and therefore, no acute DNELs have to be derived.The long-term DNEL is considered sufficient to ensure that effects from acute exposure to the substance do not occur (in accordance with ECHA Guidance on information requirements and chemical safety assessment: Chapter R.8: Characterisation of dose [concentration]-response for human health, May 2008 and Part B: Hazard Assessment, Draft new chapter B.8 Scope of Exposure Assessment, March 2010).
DNELs for local effects will not be derived, as no local effects in repeated dose studies were observed.
The following DNELs for workers will be derived:
Systemic:
Long-term inhalation workers
Long-term dermal workers
Route-to-route extrapolation
For the derivation of the DNELs:
Long-term – dermal, systemic effects
Long-term – inhalation, systemic effects
Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for (see toxicokinetic assessment).
Absorption oral (rat) = Absorption oral (human) = 10%
Absorption dermal (human) = 10%
Absorption inhalation (human) = 100%
The DNELs for human exposure are derived according to the ECETOC guidance (Technical Report No.110, October 2010).
Starting point for DNEL derivation: NOAEL ≥1000 mg/kg bw/day from an oral 28-day study in rats (highest dose tested, no effects)
Long-term inhalation, systemic effects
Route-to-route extrapolation:
Inhalation NOAEL = oral NOAEL * ABSoral-rat/ABSinh-human = 1000 * 10/100 = 100 mg/kg bw
Corrected inhalatory NOAEC = 100 * 1/0.38 * 6.7 m3/10 m3= 176 mg/m3
Safety factors:
- Interspecies extrapolation: 1
- Intraspecies extrapolation: 3
- Exposure duration: 6 (assuming chronic worker exposure)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 18
Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the worker, is set at 9.8 mg/m3.
Long-term dermal, systemic effects
Route-to-route extrapolation:
Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 1000 * 10/10 = 1000 mg/kg bw
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 3
- Exposure duration: 6 (assuming chronic worker exposure)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 72
Based on the above, the long-term DNEL for systemic effects after dermal worker exposure is set at 14 mg/kg bw/day.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.9 mg/m³
DNEL related information
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 mg/kg bw/day
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
AD-1000 is not classified for acute oral, dermal and inhalation toxicity and therefore, no acute DNELs have to be derived.The long-term DNEL is considered sufficient to ensure that effects from acute exposure to the substance do not occur (in accordance with ECHA Guidance on information requirements and chemical safety assessment: Chapter R.8: Characterisation of dose [concentration]-response for human health, May 2008 and Part B: Hazard Assessment, Draft new chapter B.8 Scope of Exposure Assessment, March 2010).
DNELs for local effects will not be derived, as no local effects in repeated dose studies were observed.
The following DNELs for workers will be derived:
Systemic:
Long-term inhalation workers
Long-term dermal workers
Route-to-route extrapolation
For the derivation of the DNELs:
Long-term – dermal, systemic effects
Long-term – inhalation, systemic effects
Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for (see toxicokinetic assessment).
Absorption oral (rat) = Absorption oral (human) = 10%
Absorption dermal (human) = 10%
Absorption inhalation (human) = 100%
The DNELs for human exposure are derived according to the ECETOC guidance (Technical Report No.110, October 2010).
Starting point for DNEL derivation: NOAEL ≥1000 mg/kg bw/day from an oral 28-day study in rats (highest dose tested, no effects)
Long term inhalation, systemic effects
Route-to-route extrapolation:
Inhalation NOAEL = oral NOAEL * ABSoral-rat/ABSinh-human = 1000 * 10/100 = 100 mg/kg bw
Corrected inhalatory NOAEC = 100 * 1/1.15 = 87 mg/m3
Safety factors:
- Interspecies extrapolation: 1
- Intraspecies extrapolation: 5
- Exposure duration: 6 (assuming chronic exposure of the general population)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 30
Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the general population is set at 2.9 mg/m3
Long term dermal, system effects
Route-to-route extrapolation:
Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 1000 * 10/10 = 1000 mg/kg bw
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 5
- Exposure duration: 6 (assuming chronic exposure of the general population)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 120
Based on the above, the long-term DNEL for systemic effects after dermal exposure of the general population is set at 8.3 mg/kg bw/day.
Long-term oral, systemic effects
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 5
- Exposure duration: 6 (assuming chronic exposure of the general population)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 120
Based on the above, the long-term DNEL for systemic effects after oral exposure of the general population, is set at 8.3 mg/kg bw/d
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.
