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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15 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:
DNEL (Derived No Effect Level)
Value:
158 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
13
Modified dose descriptor starting point:
NOAEC

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:
4.2 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:
DNEL (Derived No Effect Level)
Value:
80 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL

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

Additional information - workers

Systemic DNEL values for short term (acute) and long term exposure as cited above are based on the following calculations:

Derivation of DNELacute, dermal

The DNELacute, dermal was derived from the NOELacute, dermal of 4000 mg/kg bw, determined in an acute toxicity study with rats (EU-Method B.3, see section 7.2.3). An assessment factor of 4 was applied for interspecies variation (allometric scaling from rat to human), an additional 2.5 for other interspecies differences and a factor of 5 for intraspecies differences (workers).

DNELacute, dermal = 80 mg/kg bw.

Derivation of DNELacute, inhalation

An acute inhalation LC50acute, inhalation of 1973 mg/m3 was determined in a study equivalent or similar to OECD 403 (Acute Inhalation Toxicity, see section 7.2.2). For DNEL calculation an assessment factor of 2.5 for was applied for other interspecies differences and a factor of 5 for intraspecies differences (workers).

DNELacute, inhalation = 158 mg/m3.

Derivation of DNELlong-term, dermal

The NOELlong-term, dermal was 424 mg/kg bw/day, calculated from the NOELlong-term, oral= 424 mg/kg bw/day (see section 7.5.1) , assuming 100 % resorption through the skin. An assessment factor of 2 was applied for extrapolation from subacute to chronic exposure, of 4 for allometric scaling from rat to humans plus an additional factor of 2.5 for other interspecies differences and a factor of 5 for intraspecies differences (workers).

DNELlong-term, dermal = 4.2 mg/kg bw/day.

Derivation of DNELlong-term, inhalation

The DNELlong-term, inhalation was derived from the calculated NOEC long-term, oral of 424 mg/kg bw/day (see section 7.5.1). An assessment factor of 2 was applied for extrapolation from subacute to chronic exposure, a factor of 2.5 for other interspecies differences and a factor of 5 for the intraspecies differences (workers).

DNELlong-term, inhalation = 15.

The following DN(M)EL(s) for local effects could not be derived because no threshold value for irritation can be defined.

- Dermal DN(M)EL for acute / short-term exposure - local effects

- Inhalation DN(M)EL for acute / short-term exposure - local effects

- Dermal DN(M)EL for long-term exposure - local effects

- Inhalation DN(M)EL for long-term exposure - local effects

Bayhibit AM wasserfrei should be located into the low-hazard band according to “Guidance on information requirements and chemical safety assessment Part E: Risk Characterisation” based on the classification with R36.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
50
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
79 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC

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:
2.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
40 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL

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:
DNEL (Derived No Effect Level)
Value:
2.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
65 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

Only systemic effects were considered, as no relevant local effects were observed in any of the available studies. DNEL values for short term (acute) and long term exposure as cited above are based on the following calculations:

Derivation of DNELacute, oral

The DNELacute, oral was derived from the LD50acute, oral of greater 6500 mg/kg bw determined in an acute toxicity study with rats (EU-Method B.1tris, see section 7.2.1). An assessment factor of 4 was applied for the interspecies variation (allometric scaling from rat to human), an additional 2.5 for other interspecies differences and a factor of 10 for intraspecies differences (general population).

DNELacute, oral = 65 mg/kg bw.

Derivation of DNELacute, dermal

The DNELacute, dermal was derived from the calculated NOELacute, dermal of 4000 mg/kg bw, determined in an acute toxicity study with rats (EU-Method B.3, see section 7.2.3). An assessment factor of 4 was applied for interspecies variation (allometric scaling from rat to human), an additional 2.5 for other interspecies differences and a factor of 10 for intraspecies differences (general population).

DNELacute, dermal = 40 mg/kg bw.

Derivation of DNELacute, inhalation

An acute inhalation NOAECacute, inhalation of 184 mg/m3 was calculated from the NOELsubacute, oral (see section 7.2.2). An assessment factor of 2.5 was applied for other interspecies variations and a factor of 10 was for intraspecies differences (general population).

DNELacute, inhalation= 79 mg/m3.

Derivation of DNELlong-term, oral

The NOELlong-term, oral was 424 mg/kg bw/day (EU-Method B.7, see section 7.5.1). An assessment factor of 2 was applied for extrapolation from sub-chronic to chronic exposure, of 4 for allometric scaling from rat to humans plus an additional factor of 2.5 for other interspecies differences and a factor of 10 for the intraspecies differences (general population).

DNELlong-term, oral = 2.1 mg/kg bw/day.

Derivation of DNELlong-term, dermal

The NOELlong-term, dermal was calculated from the NOELlong-term, dermal, assuming 100 % resorption through the skin, resulting in 424 mg/kg bw/day (see Chemical Safety Report). An assessment factor of 2 was applied for extrapolation from subacute to chronic exposure, of 4 for allometric scaling from rat to humans plus an additional factor of 2.5 for other interspecies differences and a factor of 10 for the intraspecies differences (general population).

DNELlong-term, dermal = 2.1 mg/kg bw/day.

Derivation of DNELlong-term, inhalation

The DNELlong-term, inhalation was derived from the calculated NOEClong-term, oral of 424 mg/kg bw/day (see Chemical Safety Report). An assessment factor of 2 was applied for extrapolation from subacute to chronic exposure, an additional factor 2.5 for other interspecies differences and a factor of 10 for intraspecies differences (general population).

DNELlong-term, inhalation = 3.7 mg/m3.

The following DN(M)EL(s) for local effects could not be derived because no threshold value for irritation can be defined.

- Dermal DN(M)EL for acute / short-term exposure - local effects

- Inhalation DN(M)EL for acute / short-term exposure - local effects

- Dermal DN(M)EL for long-term exposure - local effects

- Inhalation DN(M)EL for long-term exposure - local effects

Bayhibit AM wasserfrei should be located into the low-hazard band according to “Guidance on information requirements and chemical safety assessment Part E: Risk Characterisation” based on the classification with R36.

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