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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
116.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
232.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Modified dose descriptor starting point:
NOAEC

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.32 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.64 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL

Workers - Hazard for the eyes

Additional information - workers

A.- ACUTE TOXICITY:

Oral exposure. Systemic effects

Starting point for acute oral effects is NOAEL=132  mg/kg/day derived from repeat dose toxicity report. Assessment factors are to be applied as follows:

(1)    the allometric scaling factor for the rat is 4;

(2)    a default factor of 2.5 accounts for additional interspecies differences;

(3)    for intraspecies differences (workers) the default factor is 5, for consumers is 10

 

For workers: DNEL= 2.64 mg/kg/day

Dermal exposure. Systemic effects

Starting point for systemic effects is oral repeat dose toxicity test were NOAEL= 132 mg/kg/day. Assessment factors are to be applied as follows:

(4)    the allometric scaling factor for the rat is 4;

(5)    a default factor of 2.5 accounts for additional interspecies differences;

(6)    for intraspecies differences (workers) the default factor is 5,

 

For workers: DNEL= 2.64 mg/kg/day

  

Inhalatory exposure. Systemic effects

Taking acute oral toxicity as a starting point, and assuming 100% absorption, critical exposures levels are as follows:

For workers: DNEL= 232.7mg/m3

 

 

B.- SKIN IRRITATION

No effects on skin irritation have been reported. Therefore this hazard is of no concern.

 

C.- REPEAT DOSE TOXICITY: Systemic effects

Dermal exposure

Dermal risk assessment is based on the oral NOAEL of 132 mg/kg/day from the repeat dose toxicity test. The worst case (100% absorption) was assumed.

The following adjustment factors are applied for the identification of the reference MOS:

(1) for duration adjustment a factor of 2 is used,

(2) the allometric scaling factor for the rat is 4;

(3) a default factor of 2.5 accounts for additional interspecies differences;

(4) for intraspecies differences (workers) the default factor is 5,

 

This gives a reference MOS of 100 for workers (2x 4 x 2.5 x 5).DNELsyst.Dermal route is established in 1.32 mg/kg/day (workers).

Oral exposure

Starting point is NOAEL of 132 mg/kg/day from a repeat dose toxicity rat study. Assuming 100% absorption and the AF described above, critical exposure levels are as follows:

Workers: 132/100= 1.32 mg/kg/day

Inhalatory exposure

The same starting point is taken as previous calculations.

For workers: DNEL= 116.4mg/m3

C.- REPRODUCTIVE

Oral exposure

Starting point is NOAELmaternal tox.= 665.5 mg/kg/day The same NOEAL was stablished for reproductive effects.

 The following adjustment factors are applied for the identification of the reference MOS:

(1) the allometric scaling factor for the rat is 4;

(2) a default factor of 2.5 accounts for additional interspecies differences;

(3) for intraspecies differences (workers) the default factor is 5,

 

Overall the reference MOS is 50 (4 x 2.5 x 5). The respective critical dermal exposure level at the workplace is identified as DNEL =13.31 mg /kg/day for workers.

For DNELdevelopment=23.7mg/kg/bw.

Dermal exposure

Same starting point and same AF were used for deriving DNELs. Worst case of 100% absorption was assumed.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
57.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
1.15
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
114.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
1.15
Modified dose descriptor starting point:
NOAEC

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.66 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.32 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.66 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.32 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

A.- ACUTE TOXICITY:

Oral exposure.Systemic effects

Starting point for acute oral effects is NOAEL=132  mg/kg/day derived from repeat dose toxicity report. Assessment factors are to be applied as follows:

(1)    the allometric scaling factor for the rat is 4;

(2)    a default factor of 2.5 accounts for additional interspecies differences;

(3)    for intraspecies differences the factor for consumers is 10

 

For consumers: DNEL= 1.32 mg/kg/day

Dermal exposure. Systemic effects

Starting point for systemic effects is oral repeat dose toxicity test were NOAEL= 132 mg/kg/day. Assessment factors are to be applied as follows:

(4)    the allometric scaling factor for the rat is 4;

(5)    a default factor of 2.5 accounts for additional interspecies differences;

(6)     for intraspecies differences the factor for consumers is 10

 

For consumers: DNEL= 1.32 mg/kg/day

  

Inhalatory exposure. Systemic effects

Taking acute oral toxicity as a starting point, and assuming 100% absorption, critical exposures levels are as follows:

For consumers: DNEL= 114.8mg/ m3

  

B.- SKIN IRRITATION

No effects on skin irritation have been reported. Therefore this hazard is of no concern.

 

C.- REPEAT DOSE TOXICITY: Systemic effects

Dermal exposure

Dermal risk assessment is based on the oral NOAEL of 132 mg/kg/day from the repeat dose toxicity test. The worst case (100% absorption) was assumed.

The following adjustment factors are applied for the identification of the reference MOS:

(1) for duration adjustment a factor of 2 is used,

(2) the allometric scaling factor for the rat is 4;

(3) a default factor of 2.5 accounts for additional interspecies differences;

(4) for intraspecies differences (consumers) the default factor is 10,

 

This gives a reference MOS of 200 for consumers (2 x 4 x 2.5 x 10). DNELsyst.Dermal route is established in 0.66 mg/kg/day (consumers).

Oral exposure

Starting point is NOAEL of 132 mg/kg/day from a repeat dose toxicity rat study. Assuming 100% absorption and the AF described above, critical exposure levels are as follows:

Consumers: 132/200= 0.66 mg/kg/day

Inhalatory exposure

Same starting point is taken as previous calculations.

For consumers: DNEL= 57.4mg/ m3

C.- REPRODUCTIVE

Oral exposure

Starting point is NOAELmaternal tox= 665.5 mg/kg/day Thesame NOEAL was stablished for reproductive effects.

 The following adjustment factors are applied for the identification of the reference MOS:

(1) the allometric scaling factor for the rat is 4;

(2) a default factor of 2.5 accounts for additional interspecies differences;

(3) for intraspecies differences (consumers) the default factor is 10,

 

Overall the reference MOS is 50 (4 x 2.5 x 10). The respective critical dermal exposure level at the workplace is identified as DNEL =6.65 mg /kg/day for workers.

For DNELdevelopment=11.85mg/kg/bw.

Dermal exposure

Same starting point and same AF were used for deriving DNELs. Worst case of 100% absorption was assumed.

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