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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
100 mg/m³
DNEL related information
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
low hazard (no threshold derived)
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:
low hazard (no threshold derived)
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:
low hazard (no threshold derived)
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