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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:
44.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
6.8
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:
12.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
24
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Short term exposure worker (systemic effects)

 

It is not possible to derive a DNEL for acute effects based on the available data. The acute toxicity of Triethylenglycoldivinylether is low with respect to the oral and dermal routes of exposure. The inhalative route is not a relevant route of exposure due to the low vapour pressure (0.0042 hPa) and use (no formation of an inhalable aerosol).

 

 

Long term exposure worker (systemic effects)

Inhalatory and dermal

The DNELs for inhalatory and dermal long term exposure are derived from the NOAEL obtained in an oral repeated dose study (BASF 73R0162/03041). In this 2-generation reproduction toxicity study (comparable to the current OECD guideline 416) rats were exposed to 0, 100, 300, 1000 mg/kg bw/day for up to 20 weeks. Effects on liver and kidney weight (with corroborative histopathological findings) were observed in males and females at 1000 mg/kg bw/day. A dose level of 300 mg/kg bw/day is considered as NOAEL.

 

Long term worker (inhalation)

Description

Value

Remark

Step 1) Relevant dose-descriptor

NOAEL: 300 mg/kg bw (OECD 416; oral; rat)

effects on liver and kidney weight

Step 2) modification of the starting point

 

 

 

1/0.38

route to route (8h exposure)

 

50/100

absorption oral to inhal.

 

6.7 m³/10 m³

to light work

Step 3) Assessment factors

 

 

Exposure duration

2

subchronic to chronic

Interspecies

1

no interspecies extrapolation for inhal.

Intraspecies

3

worker

DNEL

Value

For workers

300 mg/kg x 0.5 x 0.67 / (0.38 x 2 x 1 x 3) = 44.1 mg/m³

Factor 6.8

 

 

Long term worker (dermal)

Description

Value

Remark

Step 1) Relevant dose-descriptor

NOAEL: 300 mg/kg bw (OECD 416; oral; rat)

effects on liver and kidney weight

Step 2) modification of the starting point

 

 

 

1/1

route to route

 

1/1

absorption oral to dermal

Step 3) Assessment factors

 

 

Exposure duration

2

subchronic to chronic

Interspecies

4

extrapolation systemic effects rat to human

Intraspecies

3

worker

DNEL

Value

For workers

300 mg/kg x 1 x 1 / (2 x 4 x 3) = 12.5 mg/kg bw/d

Factor 24

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
23
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:
7.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
40
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:
7.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Short term exposure general population (systemic effects)

 

Same considerations as for the worker.

 

 

Long term exposure general population (systemic effects)

Oral, inhalatory and dermal

The DNELs for oral, inhalatory and dermal long term exposure are derived from the NOAEL obtained in an oral repeated dose study (BASF 73R0162/03041). In this 2-generation reproduction toxicity study (comparable to the current OECD guideline 416) rats were exposed to 0, 100, 300, 1000 mg/kg bw/day for up to 20 weeks. Effects on liver and kidney weight (with corroborative histopathological findings) were observed in males and females at 1000 mg/kg bw/day. A dose level of 300 mg/kg bw/day is considered as NOAEL.

 

Long term general population (oral)

Description

Value

Remark

Step 1) Relevant dose-descriptor

NOAEL: 300 mg/kg bw (OECD 416; oral; rat)

effects on liver and kidney weight

Step 2) Assessment factors

 

 

Exposure duration

2

subchronic to chronic

Interspecies

4

extrapolation systemic effects rat to human

Intraspecies

5

General population

DNEL

Value

For general population

300 mg/kg / (2 x 4 x 5) = 7.5 mg/kg bw/d

Factor 40

 

Long term general population (inhalation)

Description

Value

Remark

Step 1) Relevant dose-descriptor

NOAEL: 300 mg/kg bw (OECD 416; oral; rat)

effects on liver and kidney weight

Step 2) modification of the starting point

 

 

 

1/1.15

route to route (24h exposure)

 

50/100

absorption oral to inhal.

Step 3) Assessment factors

 

 

Exposure duration

2

subchronic to chronic

Interspecies

1

no interspecies extrapolation for inhal.

Intraspecies

5

General population

DNEL

Value

For general population

300 mg/kg x 0.5 / (1.15 x 2 x 1 x 5) = 13.0 mg/m³

Factor 23

 

 

Long term general population (dermal)

Description

Value

Remark

Step 1) Relevant dose-descriptor

NOAEL: 300 mg/kg bw (OECD 416; oral; rat)

effects on liver and kidney weight

Step 2) modification of the starting point

 

 

 

1/1

route to route

 

1/1

absorption oral to dermal

Step 3) Assessment factors

 

 

Exposure duration

2

subchronic to chronic

Interspecies

4

extrapolation systemic effects rat to human

Intraspecies

5

General population

DNEL

Value

For general population

300 mg/kg x 1 x 1 / (2 x 4 x 5) = 7.5 mg/kg bw/d

Factor 40