Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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