Registration Dossier

Diss Factsheets

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.

Categories Display