Registration Dossier
Registration Dossier
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EC number: 920-762-6 | 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:
- 23.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
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:
- 3.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- 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
Workers - Hazard for the eyes
Additional information - workers
Long-term exposure - systemic effects
Dermal DN(M) EL
DNEL derivation is based on a 28 -day toxicity study by oral administration to rats (Rokh, 2010). The starting dose for DNEL calculation was a NOAEL higher than 1000 mg/kg/day for systemic toxicity.
Considering the chemical composition of the substance ,a default oral and dermal absorption of 100% is assumed.
The application of assessment factors of 2.5 for remaining interspecies differences, 4 for allometric scaling, 5 for intraspecies differences and 6 for exposure duration from sub-acute to chronic leads to a DNEL higher than 3.3 mg/kg bw for long-term dermal exposure - systemic effects.
Inhalation (DN(M)EL
DNEL derivation is based on a 28 -day toxicity study by oral administration to rats (Rokh, 2010). The starting dose for DNEL calculation was a NOAEL higher than 1000 mg/kg/day for systemic toxicity.
Considering the chemical composition of the substance, a default oral and inhalation absorption of 100% is assumed.
The equivalent NAEC (8h) derived for workers is 1763 mg/m3 (1000 mg/kg x 1/0.38 m3/kg x 6.7 m3/10 m3) after correction for difference between respiratory rates under standard conditions and under conditions of light activity and exposure conditions.
The application of assessment factors of 2.5 for remaining interspecies differences, 5 for intraspecies differences and 6 for exposure duration from sub-acute to chronic leads to a DNEL of 23.5 mg/m3 for long-term inhalation exposure - systemic effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard for the eyes
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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