Registration Dossier
Registration Dossier
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EC number: 249-535-3 | CAS number: 29253-36-9
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:
- 6 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 150 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Dose descriptor is a NOAEL of 170 mg/kg bw/day from an oral, 6 month, repeated-dose toxicity study. The dose descriptor is converted to a corrected inhalation dose descriptor starting point by taking into account a factor of 0.38 for conversion of an oral dose descriptor to a worker 8 h inhalation exposure, differences in absorption rate (0.5 oral to 1 inhalation), and differences in the respiratory volume of human at rest (6.7 m³/person) compared to light activity for workers (10 m³/person) (corrected inhalation starting point = 170 / 0.38 x 0.5/1 x 6.7/10 = 149.9 mg/m³).
- AF for differences in duration of exposure:
- 2
- Justification:
- (sub)chronic to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- included in route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default AF
- AF for intraspecies differences:
- 5
- Justification:
- default AF for workers
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 170 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Dose descriptor is a NOAEL of 170 mg/kg bw/day from an oral, 6 month, repeated-dose toxicity study. The oral dose descriptor is converted to a corrected dermal dose descriptor starting point without any modification required. As worst-case assumption, absorption is considered to be the same for both (oral and dermal) routes.
- AF for differences in duration of exposure:
- 2
- Justification:
- (sub)chronic to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- default AF
- AF for intraspecies differences:
- 5
- Justification:
- default AF for workers
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
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:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation 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
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:
- no hazard identified
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
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