Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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.