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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.22 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Explanation for the modification of the dose descriptor starting point:

Taking NOAEL of 15 mg/kg/day from a repeat dose toxicity rat study as a starting point, and assuming 100% absorption, critical exposures levels are as follows:

For workers: DNEL= 13.22mg/m3

Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
26.45 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor starting point:
NOAEL
Value:
15 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC

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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.15 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL

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:
no hazard identified

Additional information - workers

 A.- ACUTE TOXICITY:

Oral exposure. Systemic effects

Starting point for acute oral effects is NOAEL=15  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

 

Dermal exposure. Systemic effects

Starting point for systemic effects is oral repeat dose toxicity test were NOAEL= 15 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,

 

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= 13.22mg/m3

 

B.- REPEAT DOSE TOXICITY:Systemic effects

Dermal exposure

Dermal risk assessment is based on the oral NOAEL of 15 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 1.15 mg/kg/day (workers).

 

Oral exposure

Starting point is NOAEL of 15 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: 15/100= 0.15 mg/kg/day

 

Inhalatory exposure

The same starting point is taken as previous calculations.

For workers: DNEL= 13.22 mg/ m3

 

C. SKIN IRRIRATION

The substance is not classified as skin irritant according to CLP but is R38 based on D. 67/548 criteria

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.04 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
1.15
Modified dose descriptor starting point:
LOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.04 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

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:
DNEL (Derived No Effect Level)
Value:
0.075 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Modified dose descriptor starting point:
LOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.15 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Modified dose descriptor starting point:
NOAEL

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:
DNEL (Derived No Effect Level)
Value:
0.075 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
LOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.152 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

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Oral exposure. Systemic effects

Starting point for acute oral effects is NOAEL=15 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= 0.15 mg/kg/day

Dermal exposure. Systemic effects

Starting point for systemic effects is oral repeat dose toxicity test were NOAEL= 15 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= 0.15 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= 13.04mg/ m3

 

 

B.- REPEAT DOSE TOXICITY:Systemic effects

Dermal exposure

Dermal risk assessment is based on the oral NOAEL of 15 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 1.35 mg/kg/day (consumers).

Oral exposure

Starting point is NOAEL of 15 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: 15/200= 0.075 mg/kg/day

Inhalatory exposure

Same starting point is taken as previous calculations.

For consumers: DNEL= 13.04mg/ m3