Registration Dossier
Registration Dossier
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EC number: 205-381-9 | CAS number: 139-89-9
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 88 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):
- 5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 441 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Undertaken as described in REACH Guidance R.8
- AF for dose response relationship:
- 1
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Not applicable, NOAEL based on chronic data
- Justification:
- Not applicable (scaling addressed in route to route extrapolation) in accordance with REACH Guidance R.8
- Justification:
- The toxicity of metal complexing agents, of which this substance is an example, is associated with their ability to complex metals and either enhance their excretion or prevent their absorption. They are not metabolised and are rapidly excreted. As such there are likely to be no ‘Toxicodynamic’ differences between animals and humans that would justify use an addition factor
- AF for intraspecies differences:
- 5
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor, in accordance with REACH Guidance R.8
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - 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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
DNEL derivation for each of the relevant endpoints was based on the most conservative value obtained from available animal toxicity studies and the application of relevant assessment factors.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 22 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):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 217 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Undertaken as described in REACH Guidance R.8
- AF for dose response relationship:
- 1
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Not applicable, NOAEL based on chronic data
- Justification:
- Not applicable (scaling addressed in route to route extrapolation) in accordance with REACH Guidance R.8
- Justification:
- The toxicity of metal complexing agents, of which this substance is an example, is associated with their ability to complex metals and either enhance their excretion or prevent their absorption. They are not metabolised and are rapidly excreted. As such there are likely to be no ‘Toxicodynamic’ differences between animals and humans that would justify use an addition factor
- AF for intraspecies differences:
- 10
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor, in accordance with REACH Guidance R.8
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
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:
- 12 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):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- Justification:
- Not applicable, NOAEL based on chronic data
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor (rat to human), in accordance with REACH Guidance R.8
- Justification:
- The toxicity of metal complexing agents, of which this substance is an example, is associated with their ability to complex metals and either enhance their excretion or prevent their absorption. They are not metabolised and are rapidly excreted. As such there are likely to be no ‘Toxicodynamic’ differences between animals and humans that would justify use an addition factor
- AF for intraspecies differences:
- 10
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor, in accordance with REACH Guidance R.8
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
DNEL derivation for each of the relevant endpoints was based on the most conservative value obtained from available animal toxicity studies and the application of relevant assessment factors.
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.
