Registration Dossier
Registration Dossier
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EC number: 402-600-1 | CAS number: 765-12-8
Toxicological Summary
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
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