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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:
3.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
12.5
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

A.- ACUTE TOXICITY:

No acute effects were seen. Therefore no acute DNELs are necessary to be derived.

 

B.-SKIN IRRITATION AND SENSITIZATION. Acute Local effects

The substance is not skin irritant. No DNEL need to be derived.

C.- REPEAT DOSE TOXICITY:Systemic effects

Long term Oral exposure

Starting point is NOAEL of 25 mg/kg/day from a chronic toxicity rat study.

The following adjustment factors are applied:

(1) for duration adjustment no factor is needed,

(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, and for consumers is 10

 

This gives a reference AF of 50 for workers (4 x 2.5 x 5), and 100 for consumers (4 x 2.5 x 10)

Assuming 100% absorption critical exposure levels are as follows:

DNEL Workers: = 0.5 mg/kg/day

DNELConsumers =0.25 mg/kg/day

 

Long term Dermal exposure

Dermal risk assessment is based on the oral NOAEL of 25 mg/kg/day from a chronic toxicity test. The worst case (100% absorption) was assumed.

 

DNELworkers= 0.5 mg/kg/day

DNELConsumers =0.25 mg/kg/day

 

Long term Inhalatory exposure

Same starting point is taken as previous calculations.

 

Worker Population - NOAEL of 25 mg/kg/d /m3/kg * [6.7 m3/ 10 m3] = 44.07 mg/m3.

General Population - NOAEL of 25 mg/kg/d / 1.16 m3/kg = 21.5 mg/m3

 

Assessment factors are:

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

2)     for intraspecies differences (workers) the default factor is 5, and 10 for consumers:

 

 

DNEL inhalation, systemic, chronic worker population = 44.07 / 12.5 = 3.5 mg/m3.

DNEL inhalation, systemic, chronic general population = 21.5 / 25 = 0.86 mg/m3

 

C.- REPRODUCTIVE AND DEVELOPMENT TOXICITY

Oral exposure

Starting point is NOAELfert.= 25 mg/kg/day from a reproductionstudy on rats.

 

The following adjustment factors are applied:

(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

 

Overall the reference AF is 50 (4 x 2.5 x 5) .The respective critical oral exposure levels at the workplace is identified as:

 

DNEL = 0.5 mg /kg/day for workers and

 

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:
0.86 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 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:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Value:
0.25 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:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population