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EC number: 203-794-9 | CAS number: 110-71-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 30
- 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:
- 1.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Workers:
According
to RIP 3.2.2, Chapter R8, R8.1.2.5, p. 16 no acute DNELs were derived
since no acute toxicity hazard has been identified. The long-term DNEL
concerning reprotoxic (developmental) effects also covers possible acute
toxic effects.
Long-term dermal systemic DNEL based on NOAEC (14 d,
inhalation) in rats:
- derived systemic NOAEL: 132.6 mg/kg bw/d (for calculation details
please refer to Endpoint summary“Reproductive toxicity”)
- NOAEL(dermal) derived according to “Guidance on information
requirements and chemical safety assessment”, Chapter R8-2, Example B.5
(p. 69).
corrected NOAEL(dermal) = NOAEL(systemic, rat) x
Absorption(inhal-rat)/Absorption(dermal-human)
= 132.6 mg/kg bw/d x
100%/100%
= 132.6 mg/kg bw/d
- DNEL(dermal) derived from corrected NOAEL(dermal) applying the
assessment factor 120 (4(interspecies rat-human) x 5(intraspecies
worker) x 6(subacute-chronic))
=> =1.1 mg/kg bw/d
Long-term inhalatory DNEL based on NOAEL (14 d,
inhalation) in rats:
- NOAEC(inhalation) derived according to “Guidance on information
requirements and chemical safety assessment”, Chapter R8.4, Figure 8-2
(p. 27).
corrected
NAEC(inhalation) = NOAEC(inhal., rat) x 6(h/d)/8(h/d) x 6.7 m3/10 m3
= 187 mg/m3x
6(h/d)/8(h/d) x 6.7 m3/10 m3
= 94.0 mg/m3
- DNEL(inhalation) derived from corrected NOAEC(inhalation)
applying the assessment factor 30 (5(intraspecies) x 6(subacute-chronic))
=>= 3.1 mg/m3
The 14 days inhalation study in rats was chosen for the long-term DNEL derivation for workers since the rat is the commonly accepted and best investigated species for repeated dose toxicity studies. Furthermore, it can be assumed that workers are trained in handling chemicals and according to general occupational health regulations an exposure of pregnant workers to Ethylene glycol dimethyl ether at the production site is excluded. Ethylene glycol dimethyl ether is labeled as reprotoxic and teratogenic.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 10
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:
- 0.23 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 24
- 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:
- 0.23 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
According to RIP 3.2.2, Chapter R8, R8.1.2.5, p. 16 no acute DNELs were derived since no acute toxicity hazard has been identified. The long-term DNEL concerning reprotoxic (developmental) effects also covers possible acute toxic effects.
Long-term oral systemic DNEL based on NOAEC (14d,
inhalation teratognicity study) in rabbits: 5.6 mg/kg bw/d
(for calculation details please refer to Endpoint summary“Reproductive
toxicity”)
applying assessment factor 24 (2.4(interspecies rabbit-human) x 10
(intraspecies general population))
=> =0.23 mg/kg bw/d
Long-term dermal systemic DNEL based on NOAEC (14 d,
inhalation teratogenicity study) in rabbits:
- derived systemic NOAEL: 5.6 mg/kg bw/d (for calculation details please
refer to Endpoint summary“Reproductive toxicity”)
- NOAEL(dermal) derived according to “Guidance on information
requirements and chemical safety assessment”, Chapter R8-2, Example B.5
(p. 69).
-corrected NOAEL(dermal)
= NOAEL(systemic, rabbit) x Absorption(inhal-rabbit)/Absorption(dermal-human)
= 5.6 mg/kg bw/d x 100%/100%
= 5.6 mg/kg bw/d
- DNEL(dermal) derived from corrected NOAEL(dermal) applying the
assessment factor 24 (2.4(interspecies rabbit-human) x 10(intraspecies
general population))
=> =0.23 mg/kg bw/d
Long-term inhalatory DNEL based on NOAEC (14 d, inhalation teratogenicity study) in rabbits:
- NOAEC(inhalation) derived according to “Guidance on information requirements and chemical safety assessment”, Chapter R8.4, Figure 8-2 (p. 27).
corrected NAEC(inhalation) = NOAEC(inhal., rabbit) x 6(h/d)/24(h/d)
= 60 mg/m3x 6(h/d)/24(h/d)
= 15.0 mg/m3
- DNEL(inhalation) derived from corrected NOAEC(inhalation) applying the assessment factor 10(intraspecies)
=>= 1.5 mg/m3
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