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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:
84 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10.5
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

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:
60 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
42
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

DNELS:

Acute (systemic and local); long term (local)

No DNELS have been calculated for these endpoints due to the low order of acute toxicity via all routes, and absence of any local effects in repeated dose and short term toxicity studies.

Inhalation DNEL, Systemic, long-term

Starting point for DNEL derivation:

13 week oral drinking water study in the rat. NOEL 500 mg/kg bw

Adjusted starting point: 500/0.38 * 6.7/10 = 881 mg/m3

Assessment Factors:

Allometric scaling - taken into consideration in adjustment of starting point

Other Differences - 2.5

Duration of study - 1.4 (based on publication of Batke et al 2011; Toxicology letters 205; 122 -129)

Worker variability - 3 - based on minimal toxicological profile and the recent work of ECETOC, deviation from the default factor of 5 is considered justified.

Total factor: 10.5

Inhalation DNEL = 881/10.5 = 84 mg/m3

Dermal DNEL, systemic, long-term

Starting point for DNEL derivation:

13 week oral drinking water study in the rat. NOEL 500 mg/kg bw

Based on the toxicokinetics data supporting the dermal developmental toxicity study, approximately 20% of an applied dose of the substance penetrated into systemic circulation. This value will be taken for the conversion of the NOEL from oral to dermal route.

It is assumed that 100% of the oral dose is absorbed.

Adjusted starting point = 500 * 100/20 = 2500 mg/kg bw/day

Assessment factors:

Allometric scaling - 4

Other Differences - 2.5

Duration of study - 1.4 (based on publication of Batke et al 2011; Toxicology letters 205; 122 -129)

Worker variability - 3 - based on minimal toxicological profile and the recent work of ECETOC, deviation from the default factor of 5 is considered justified.

Total factor = 42

Dermal DNEL = 60 mg/kg bw/day

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
21
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

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:
30 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
84
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
84
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

DNELS:

Acute (systemic and local); long term (local)

No DNELS have been calculated for these endpoints due to the low order of acute toxicity via all routes, and absence of any local effects in repeated dose and short term toxicity studies.

Inhalation DNEL, Systemic, long-term

Starting point for DNEL derivation:

13 week oral drinking water study in the rat. NOEL 500 mg/kg bw

Adjusted starting point: 500/1.15 = 435 mg/m3

Assessment Factors:

Allometric scaling - taken into consideration in adjustment of starting point

Other Differences - 2.5

Duration of study - 1.4 (based on publication of Batke et al 2011; Toxicology letters 205; 122 -129)

Worker variability - 6 - based on minimal toxicological profile and the recent work of ECETOC, deviation from the default factor of 10 is considered justified.

Total factor: 21

Inhalation DNEL = 435/21 = 21 mg/m3

Dermal DNEL, systemic, long-term

Starting point for DNEL derivation:

13 week oral drinking water study in the rat. NOEL 500 mg/kg bw

Based on the toxicokinetics data supporting the dermal developmental toxicity study, approximately 20% of an applied dose of the substance penetrated into systemic circulation. This value will be taken for the conversion of the NOEL from oral to dermal route.

It is assumed that 100% of the oral dose is absorbed.

Adjusted starting point = 500 * 100/20 = 2500 mg/kg bw/day

Assessment factors:

Allometric scaling - 4

Other Differences - 2.5

Duration of study - 1.4 (based on publication of Batke et al 2011; Toxicology letters 205; 122 -129)

Worker variability - 6 - based on muinimal toxicological profile and the recent work of ECETOC, deviation from the default factor of 10 is considered justified.

Total factor = 84

Dermal DNEL = 30 mg/kg bw/day

Oral DNEL, systemic, Long-term

Starting point for DNEL derivation: 500 mg/kg bw/day

No adjustment necessary for NOEL

Assessment factors:

Allometric scaling - 4

Other Differences - 2.5

Duration of study - 1.4 (based on publication of Batke et al 2011; Toxicology letters 205; 122 -129)

Worker variability - 6 - based on muinimal toxicological profile and the recent work of ECETOC, deviation from the default factor of 10 is considered justified.

Total factor = 84

Oral DNEL = 500/84 = 6 mg/kg bw/day