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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.097 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEC
Value:
0.138 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
0.966 mg/m³
Explanation for the modification of the dose descriptor starting point:

The inhalation point of departure can be expressed as 0.966 mg/m3when taking into account the default body weight of 70 kg and a respiratory rate associated with a volume of light activity for a worker of 10m3/day cited in the REACH guidance document (ECHA, Chapter R8)

AF for dose response relationship:
1
Justification:
A factor of 1 is appropriate since the dose descriptor is a NOAEC
AF for differences in duration of exposure:
1
Justification:
Data is from a 21-day steady state exposure. Data demonstrates that a greater degree of cholinesterase inhibition is not generally observed in studies of longer duration
AF for other interspecies differences:
1
Justification:
No significant species differences observed in relation to RBC AChE inhibition
AF for intraspecies differences:
10
Justification:
for female workers of reproductive age
AF for the quality of the whole database:
1
Justification:
A factor of 1 is appropriate because the database is considered to be adequately robust
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.6 mg/m³
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
NOAEC
Value:
3.7 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
7.2 mg/m³
Explanation for the modification of the dose descriptor starting point:

Using the Haber’s equation C3x T = K

Concentration from study is 3.7 mg/m3; Time = 6 h; n=3 according to REACH guidance

3.73X 6 = K

K = 50.7 X 6 = 304.2

 

We are looking now at a time period of 15 mins = 0.25 h; K = 300; n=3

 

C3x 0.25 = 304.2

C3= 1216.8

C = 10.7 mg/m3

 

Modification based on difference in air intake between at rest and light activity using a factor of 0.67.

 

10.7 x 0.67 = 7.2 mg/m3

AF for dose response relationship:
1
Justification:
A factor of 1 is appropriate since the dose descriptor is a NOEC
AF for other interspecies differences:
2.5
Justification:
2.5 for differences not related to allometric scaling
AF for intraspecies differences:
5
Justification:
effects for workers
AF for the quality of the whole database:
1
Justification:
A factor of 1 is appropriate because the database is considered to be adequately robust

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.36 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEL
Value:
3.63 mg/kg bw/day
AF for dose response relationship:
1
Justification:
A factor of 1 is appropriate since the dose descriptor is a NOAEL
AF for differences in duration of exposure:
1
Justification:
Data is from a 21-day steady state exposure. Data demonstrates that a greater degree of cholinesterase inhibition is not generally observed in studies of longer duration
AF for other interspecies differences:
1
Justification:
No significant species differences observed in relation to RBC AChE inhibition
AF for intraspecies differences:
10
Justification:
for female workers of childbearing age
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

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:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population