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Registration Dossier
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EC number: 236-813-4 | CAS number: 13494-80-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.4 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 31.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The route to route extrapolation was conducted according to Appendix R8.2 of the ECHA Guidance document "Chapter R.8: Characterisation of dose [concentration]-response for human"
- Justification:
- Subacute -> chronic
- Justification:
- Still applied by route to route extrapolation for deriving NOAEC by using allometric scaling
- Justification:
- Default value according to ECHA REACH Guidance
- Justification:
- Default value according to ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 0.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 180 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The route to route extrapolation was conduted according to Health Risk Assessment Guidance for Metals (HERAG).
- Justification:
- Subacute -> chronic
- Justification:
- Rat-> human; Default value according to ECHA REACH Guidance
- Justification:
- Default value according to ECHA REACH Guidance
- Justification:
- Default value according to ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 15.75 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The route to route extrapolation was conducted according to Appendix R8.2 of the ECHA Guidance document "Chapter R.8: Characterisation of dose [concentration]-response for human"
- Justification:
- Subacute->chronic, default value according to ECHA REACH Guidance
- Justification:
- Still applied by route to route extrapolation for deriving NOAEC by using allometric scaling
- Justification:
- Default value according to ECHA REACH Guidance
- Justification:
- Default value according to ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 0.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 180 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The route to route extrapolation was conduted according to Health Risk Assessment Guidance for Metals (HERAG).
- Justification:
- subacute->chronic
- Justification:
- rat-> human, default value according to ECHA REACH Guidance
- Justification:
- Default value according to ECHA REACH Guidance
- Justification:
- Default value according to ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 0.03 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 18 mg/kg bw/day
- Justification:
- Subacute->chronic
- Justification:
- Rat->human, default value according to ECHA REACH Guidance
- Justification:
- Default value according to ECHA REACH Guidance
- Justification:
- Default value according to ECHA REACH Guidance
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.
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