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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:
100 mg/m³
DNEL related information
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
250 mg/m³
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15.4 mg/kg bw/day
DNEL related information
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Worker-DNEL long-term for dermal route-systemic

Relevant dose-descriptor for the endpoint concerned:OEL of 100 mg/m3 (SEG/SUM/29, 1993)

 

Correction of starting point:

Route of exposure (inhalation versus dermal exposure): OEL of 100 mg/m3 is converted to 1000 mg/person/day assuming a breathing volume of 10 m3 in workers.

Similar exposure conditions (occupational exposure during 8 h shift).

Average person weight of 65 kg

 

100 mg/m3 x 10 m3/d /65 kg= 15.4 mg/kg bw/d

 

Assessment factors relating to the extrapolation procedure:

Assessment factors have been included in derivation of OEL, therefore no further assessment factor

 

Overall assessment factor: 0

 

DNEL worker long-term dermal systemic = 15.4 mg/kg bw/day

 

 

Worker-DNEL long-term for inhalation route-systemic

Relevant dose-descriptor for the endpoint concerned: SCOEL (1993) used the NOAEL of 100 ppm (500 mg/m³) for CNS effects in a 90d study in rats. This was considered to be the best available basis for proposing occupational exposure limits.

 

Assessment factors relating to the extrapolation procedure:

According to SCOEL, an uncertainty factor of 5 was considered appropriate because of the absence of human data.

DNEL worker long-term inhalation systemic = 100 mg/m3 (20 ppm)

 

Worker-DNEL acute for inhalation route-local

According to SCOEL, a STEL (15 mins) of 50 ppm (250 mg/m³) was proposed to limit peaks of exposure which could result in irritation. A “skin” notation was recommended as dermal absorption could contribute substantially to the total body burden.

 

DNEL worker acute inhalation local: 250 mg/m3 (50 ppm)

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
16.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
2
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.2 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
2
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
2
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

General population -DNEL long-term for dermal route-systemic

Relevant dose-descriptor for the endpoint concerned:OEL of 100 mg/m3 (SEG/SUM/29, 1993)

 

Correction of starting point:

Route of exposure (inhalation versus dermal exposure): the OEL of 100 mg/m³ is converted to 2000 mg/person/day assuming a breathing volume of 20 m3 in general population

Exposure conditions (occupational exposure versus continuous exposure): daily exposure: workers: 8 h/d; general population: 24 h/d = factor 0.33

Average person weight of 65 kg

 

100 mg/m3 x 20 m3/d x 0.33 /65 kg= 10.2 mg/kg bw/d

 

Assessment factors relating to the extrapolation procedure

Interspecies differences: not necessary as OEL was starting point, and already included AF for interspecies differences.

Intraspecies differences: assessment factor of 2 due to differences between worker and general population

 

Overall assessment factor: 2

DNEL general population chronic dermal systemic: 5 mg/kg bw/day

 

 

General population -DNEL long-term for inhalation route-systemic

Relevant dose-descriptor for the endpoint concerned:OEL of 100 mg/m3 (SEG/SUM/29, 1993)

 

Correction of starting point

Same route of exposure.

Exposure conditions (occupational exposure versus continuous exposure): daily exposure: workers: 8 h/d; general population: 24 h/d = factor 0.33.

 

100 mg/m3 x 0.33 = 33.3 mg/m3

 

Assessment factors relating to the extrapolation procedure:

Interspecies differences: not necessary as OEL was starting point, and already included AF for interspecies differences.

Intraspecies differences: assessment factor of 2 due to differences between worker and general population

 

Overall assessment factor: 2

DNEL general population long-term inhalation systemic = 16.6 mg/m3

 

 

General population-DNEL long-term for oral route-systemic

Relevant dose-descriptor for the endpoint concerned:OEL of 100 mg/m3 (SEG/SUM/29, 1993)

 

Correction of starting point:

Route of exposure (inhalation versus oral exposure): the OEL of 100 mg/m3 is converted to 2000 mg/person/day assuming a breathing volume of 20 m3 in general population;

Exposure conditions (occupational exposure versus continuous exposure): Daily exposure: workers: 8 h/d; general population: 24 h/d = factor 0.33.

Average person weight of 65 kg

 

100mg/m3 x 20 m3/d x 0.33 /65 kg= 10.2 mg/kg bw/d

 

Assessment factors relating to the extrapolation procedure:

Interspecies differences: not necessary as OEL was starting point, and already included AF for interspecies differences.

Intraspecies differences: assessment factor of 2 due to differences between worker and general population

 

Overall assessment factor: 2

DNEL general population long-term oral systemic: 5 mg/kg bw/day