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Administrative data

Description of key information

Acute Oral Toxicity: An LD50 value of 5170mg/kg was obtained.
Acute Dermal Toxicity: An LD50 value of 3450 mg/kg was obtained.
Acute Inhalation toxicity:An LC50 value of 2400 mg/m3 was obtained.
It is concluded that the substance2-(2-(2-butoxyethoxy)ethoxy)ethanol does not meet the criteria to be classified for human health hazards for acute effects.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
5 170 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
2 400 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
3 450 mg/kg bw

Additional information

Acute toxicity: oral

In a reliable acute oral toxicity study where original data is available, male and female rats were subjected to doses of up to 6400ml/kg of 2-(2-(2-butoxyethoxy)ethoxy)ethanol and subsequently observed for a period of 14 days. An LD50 value of 5170mg/kg was obtained.

In other study report where key experimental details were reported, an LD50 of 5300 mg/kg was established in male rats.

In an old study report where key experimental details were reported, an LD50 of 6650mg/kg was established in male rats.

Acute Dermal Toxicity:

In an acute dermal toxicity in rabbits in which only basic details were reported, an LD50 of 3540 mg/kg was obtain. Exposure was under occluded conditions.

In an acute dermal toxicity in rabbits, no effects were reported after 24-hr dermal exposure of rabbits to  2000 mg/kg.

An NOAEL= 2000 mg/kg was obtain.

Acute Inhalation toxicity:

In an acute inhalation toxicity designed to assess vapour concentrations that did not cause death, groups of 6 animals were exposed sequentially to increasing concentrations of 2-(2-(2-butoxyethoxy)ethoxy)ethanol.

8 hours exposure to 1200mg/l caused no deaths whereas 16 hours at 2400mg/l caused 3/6 animals to die. Based on this study, the LC50 would be >2400 mg/l.

It can be concluded that the test substance does not present an acute inhalation hazard.

In an acute inhalation toxicity designed to assess vapour concentrations that did not cause death, groups of 10 animals were exposed sequentially to increasing concentrations of 2-(2-(2-butoxyethoxy)ethoxy)ethanol. 1 hour exposure to 200mg/l caused no deaths.

No clinical signs of toxicity were reported. It can be concluded that the test substance does not present an acute inhalation hazard.

 

Justification for classification or non-classification

Based on the hazard assessment of2-(2-(2-butoxyethoxy)ethoxy)ethanolin section 2.1 and 2.2. in IUCLID 5.3., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99)and according to the criteria described in Directive 67/548 and in the CLP Regulation:

Directive 67/548

Very Toxic (T+)

R28: Very toxic if swallowed

R27: Very toxic in contact with skin

R26: Very toxic by inhalation

R39/26 R39/27 R39/28: Dangerous of very serious irreversible effects

Toxic (T): 

R25: Toxic if swallowed

R24: Toxic in contact with skin

R23: Toxic by inhalation

R39/23 R39/24 R39/25: Danger of very serious irreversible effects

Harmful (Xn):

R22: Harmful if swallowed

R21: Harmful in contact with skin

R20: Harmful by inhalation

R65: Harmful may cause lung damage if swallowed

R68/20 R68/21 R68/22: Possible risk of irreversible effects

Other toxicological properties

R67: Vapours may cause drowsiness and dizziness

CLP

H300 Acute Tox. 2 Fatal if swallowed

H310 Acute Tox. 1 Fatal in contact with skin

H330 Acute Tox. 2 Fatal if inhaled

H370 STOT SE 1

H301 Acute Tox. 3 Toxic if swallowed

H311 Acute Tox. 3 Toxic in contact with skin

H331 Acute Tox. 3 Toxic if inhaled

H370 STOT SE 1

H302 Acute Tox. 4 Harmful if swallowed

H312 Acute Tox. 4 Harmf

It is concluded that the substance2-(2-(2-butoxyethoxy)ethoxy)ethanol does not meet the criteria to be classified for human health hazards for acute effects.