Registration Dossier
Registration Dossier
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EC number: 203-327-9 | CAS number: 105-75-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.2 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):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
rat: oral to inhalation scaling sRV rat: 0,38 m3/kg bw
sRV: human 8 hour inhalation volume: 6.7 m3
wRV: Worker 8 hour inhalation volume: 10 m3
corrected NOAEC inh human =NOAEL (rat, oral) * sRV rat * sRV human/wRV
- AF for dose response relationship:
- 1
- Justification:
- assuming oral exposure is equal effective as inhalatory exposure
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic (90 days) to chronic, according to Tabel R.8-6 default assessment factors
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human, according to Table R.8-3 Allometric scaling for different speices as compared to humans
- AF for other interspecies differences:
- 1
- Justification:
- Assuming no specific sensitivity for humans
- AF for intraspecies differences:
- 5
- Justification:
- worker, according to Tabel R.8-6 default assessment factors
- AF for the quality of the whole database:
- 1
- Justification:
- full dataset available
- AF for remaining uncertainties:
- 1
- Justification:
- full dataset available
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 0.07 mg/kg bw/day
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 540
- Dose descriptor starting point:
- LOAEL
- Value:
- 36.9 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
LOAEL = 36.9 mg/kg bw/day = induction dose derived from GPMT:
intradermal induction dose: 10% (v/v) in cornoil
intradermal induction 3 times 0.1 ml in shoulder (OECD 406) => 30 ul DBF
Density DBF = 0.9837 g/ml (Wenighover, 2010)
30 ul DBF = 29.51 mg DBF/animal
1 guinea pig = 0.8 kg (table R.8 -3 Allometric scaling factors for different species)
LOAEL induction = 36.9 mg/kg bw.
LOAEL induction = 118 mg/kg bw: intradermal induction with 10% (v/v) in cornoil intradermal induction of 3 times 0.1 ml => 30 ul DBF Density DBF = 0.9837 g/ml
30 ul DBF = 29.5 mg DBF/animal
1 guinea pig = 0.8 kg (Table R.8-3 allometric scaling factors)
LOAEL induction is 36.9 mg/kg bw
1 guinea pig = 0.8 kg (Table R.8-3 allometric scaling factors)
LOAEL induction is 36.9 mg/kg bw
LOAEL induction = 118 mg/kg bw: intradermal induction with 10% (v/v) in cornoil intradermal induction of 3 times 0.1 ml => 30 ul DBF Density DBF = 0.9837 g/ml 30 ul DBF = 29.5 mg DBF/animal 1 guinea pig = 0.8 kg (Table R.8-3 allometric scaling factors) LOAEL induction is 36.9 mg/kg bw
- AF for dose response relationship:
- 1
- Justification:
- 10% (v/v) intradermal induction resulted in 80% (100%-20% control) sensitized animals
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic, according to Table R.8-6 default assessment factors
- AF for interspecies differences (allometric scaling):
- 3
- Justification:
- guinea pig to human, according to Table R.8-3 Allometric saling factors for different species as compared to humans
- AF for other interspecies differences:
- 1
- Justification:
- assuming no specific sensitivity for humans
- AF for intraspecies differences:
- 5
- Justification:
- worker, according to Table R.8-6 default assessment factors
- AF for the quality of the whole database:
- 1
- Justification:
- full dataset availalbe
- AF for remaining uncertainties:
- 1
- Justification:
- full dataset available
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.07 mg/kg bw/day
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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
Intended use: only workers in industrial settings.
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