Registration Dossier
Registration Dossier
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EC number: 200-090-3 | CAS number: 51-34-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 173 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 2.46 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4.34 mg/m³
- Explanation for the modification of the dose descriptor starting point:
=NOAEL *6.7/10/0.38 (see REACH guidance chapter R.8, 2012)
- Justification:
- see REACH guidance R.8
- Justification:
- basis is chronic study
- Justification:
- see REACH guidance R.8, included in modified dose descriptor
- Justification:
- see REACH guidance R.8
- Justification:
- see REACH guidance R.8
- Justification:
- Studies are complete, consistent and availble in good quality. Read across from hydrobromide to free base is considered not to add systemic uncertainty.
- Justification:
- Use of scopolamine hydrobromid read across
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 24.6 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 2.46 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.615 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal absorption rate factor versus oral is taken as 1. Allometric scaling factor of 4 used in modified dose descriptor as per REACH guidance chapter R.8 (2012).
- Justification:
- see REACH guidance R.8, included in modified dose descriptor
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 87 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 2.46 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4.34 mg/m³
- Explanation for the modification of the dose descriptor starting point:
=NOAEL *6.7/10/0.38 (see REACH guidance chapter R.8, 2012)
- Justification:
- see REACH guidance R.8
- Justification:
- chronic 2-year study
- Justification:
- see REACH guidance R.8, included in modified dose descriptor
- Justification:
- see REACH guidance R.8
- Justification:
- see REACH guidance R.8
- Justification:
- Studies are complete, consistent and availble in good quality. Read across from hydrobromide to free base is considered not to add systemic uncertainty.
- Justification:
- not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.3 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 2.46 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.615 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Dermal absorption rate factor versus oral is taken as 1. Allometric scaling included in modified dose descriptor as per REACH guidance chapter R.8 (2012).
- Justification:
- see REACH guidance R.8
- Justification:
- chronic 2-year study
- Justification:
- see REACH guidance R.8, included in modified dose descriptor
- Justification:
- see REACH guidance R.8
- Justification:
- see REACH guidance R.8
- Justification:
- Studies are complete, consistent and availble in good quality. Read across from hydrobromide to free base is considered not to add systemic uncertainty.
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.3 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- Dose descriptor starting point:
- NOAEL
- Value:
- 2.46 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.615 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Allometric scaling included in modified dose descriptor as per REACH guidance chapter R.8 (2012).
- Justification:
- see REACH guidance R.8
- Justification:
- chronic 2-year study
- Justification:
- see REACH guidance R.8, included in modified dose descriptor
- Justification:
- see REACH guidance R.8
- Justification:
- see REACH guidance R.8
- Justification:
- Studies are complete, consistent and availble in good quality. Read across from hydrobromide to free base is considered not to add systemic uncertainty.
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
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