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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:
4.6 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):
5
Modified dose descriptor starting point:
NOAEC
Value:
23 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.6 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):
5
Modified dose descriptor starting point:
NOAEC
Value:
23 mg/m³

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
NOAEC

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
28.28 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):
5
Modified dose descriptor starting point:
NOAEL
Value:
141.4 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
40 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.79 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.79 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor starting point:
other: NOAEL

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

Reaction mass of SEX/Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide

Workers

Humans differ in sensitivity due to a number of biological factors (such as age, gender, genetic composition and nutritional status). The intraspecies variation in humans is greater than in the more homogeneous experimental animal population

The data from animal studies are the starting point for risk characterisation.The default assumption in general is that humans are more sensitive than experimental animals.The traditional default AF(Assessment factor) suggested for interspecies extrapolation is 5 for workers and 10 for general population should be applied to the concentration/dose descriptor.

A lower default factor is generally suggested for the worker population, because the very young and very old are not part of this population.

To cover the intra-species variation, the default AF(Assessment factor)of 5 for workers was applied to the concentration/dose descriptor (NOAEL or NOAEC).

 

The dose descriptor for dermal irritation/corrosion come from dermal acute study. In this study, the dose is reported in the unit mg/kg of body weight/day. This needs to be modified to enable comparison with the human exposure, generally expressed in mg/cm2/day.

We have taken that:

• the average weight of rats is 250g (200-300g), and the average weight of rabbit is 2.5 kg used by Hazleton Laboratories,1951.

• the dose is applied over an area which is approximately 10% of the total body surface, and

• the total body surface of rats is on the average 445 cm2  (363 to 527 cm2) and 1270 cm2ofrabbit used by Hazleton Laboratories,1951

 

 

The generic modification from the NOAELtest (in mg/kg of body weight) to NOAELmodified (in mg/cm2/day) will be

NOAELin mg/cm2 =        ((dose in mg/kg bw)x (average animal weight in kg)) / Treated surface in cm2)

 

NOAELtest* 2.5/127= NOAELmodified

 

The highest dose not causing irritation/corrosion was 200 mg/kg bw in the acute study of Hazleton Laboratories,1951, the modified dose descriptor would be

NOAELmodified =200 mg/kg*2.5 kg/127cm2=3.94 mg/cm2

 

 

 

 

 

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.3 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
Modified dose descriptor starting point:
NOAEC
Value:
23 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.3 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
Modified dose descriptor starting point:
NOAEC
Value:
23 mg/m³

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEC

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.14 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
Modified dose descriptor starting point:
NOAEL
Value:
141.4 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
20 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.394 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.394 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
other: NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.6 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
Value:
146 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.6 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
Value:
146 mg/kg bw/day

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

Reaction mass of SEX/Reaction mass of ethanol and sodium O-ethyl dithiocarbonate and sodium hydroxide

General population

Humans differ in sensitivity due to a number of biological factors (such as age, gender, genetic composition and nutritional status). The intraspecies variation in humans is greater than in the more homogeneous experimental animal population

The data from animal studies are the starting point for risk characterisation.The default assumption in general is that humans are more sensitive than experimental animals.The traditional default AF(Assessment factor) suggested for interspecies extrapolation is 5 for workers and 10 for general population should be applied to the concentration/dose descriptor.

A lower default factor is generally suggested for the worker population, because the very young and very old are not part of this population.

To cover the intra-species variation, the default AF (Assessment factor) of 10 for general population was applied to the concentration/dose descriptor (NOAEL or NOAEC).

 

The dose descriptor for dermal irritation/corrosion come from dermal acute study. In this study, the dose is reported in the unit mg/kg of body weight/day. This needs to be modified to enable comparison with the human exposure, generally expressed in mg/cm2/day.

We have taken that:

• the average weight of rats is 250g (200-300g), and the average weight of rabbit is 2.5 kg used by Hazleton Laboratories,1951.

• the dose is applied over an area which is approximately 10% of the total body surface, and

• the total body surface of rats is on the average 445 cm2  (363 to 527 cm2) and 1270 cm2ofrabbit used by Hazleton Laboratories,1951

 

 

The generic modification from the NOAELtest (in mg/kg of body weight) to NOAELmodified (in mg/cm2/day) will be

NOAELin mg/cm2 =        ((dose in mg/kg bw)x (average animal weight in kg)) / Treated surface in cm2)

 

NOAELtest* 2.5/127= NOAELmodified

 

The highest dose not causing irritation/corrosion was 200 mg/kg bw in the acute study of Hazleton Laboratories,1951, the modified dose descriptor would be

NOAELmodified =200 mg/kg*2.5 kg/127cm2=3.94 mg/cm2