Registration Dossier

Administrative data

Description of key information

2-(2-(2-butoxyethoxy)ethoxy)ethanol  has of relatively low subchronic toxicity (NOAEL, oral, rat: 502.5 mg/kg bw day);
2-(2-(2-butoxyethoxy)ethoxy)ethanol has of relatively low subchronic toxicity (NOAEL, dermal, rat: 5025.1mg/kg bw day);
2-(2-(2-butoxyethoxy)ethoxy)ethanol has of relatively low subchronic toxicity (NOAEC, inhalation, rat: 120 mg/m3);
It is concluded that the substance 2-(2-(2-butoxyethoxy)ethoxy)ethanol does not meet the criteria to be classified for human health hazards for Repeated dose toxicity

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
502.5 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEC
120 mg/m³
Study duration:
subchronic
Species:
rat

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
5 025.1 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Mode of Action Analysis / Human Relevance Framework

Additional information

Oral repeated dose toxicity

The substance triethylene glycol butyl ether (TEGBE or 2 -(2 -(2 -butoxyethoxy)ethoxy)ethanol, the subject of this dossier) is expected to exhibit very similar toxicity due to its close structural similarity to TEGME. Comparable metabolism would occur.

On a molecular weight scaled basis, the LOAEL would be 1507.6 mg/kgbw/day and the NOEL 502.5 mg/kgbw/day.

(400 x 206.28) / 164.2 =502.5 mg/kg bw/day

Dermal repeated dose toxicity

The substance triethylene glycol butyl ether (TEGBE or 2 -(2 -(2 -butoxyethoxy)ethoxy)ethanol, the subject of this dossier) is expected to exhibit very similar toxicity due to its close structural similarity to TEGME. Comparable metabolism would occur. On a molecular weight scaled basis, the NOAEL would be 5025.1mg/kgbw/day.

(4000 x 206.28) / 164.2 =5025.1 mg/kg bw/day

Inhalation repeated dose toxicity

The substance triethylene glycol butyl ether (TEGBE or 2 -(2 -(2 butoxyethoxy)ethoxy)ethanol, the subject of this dossier) is expected to exhibit very similar toxicity due to its close structural similarity to 2 -(2 -butoxyethoxyethanol). Comparable metabolism would occur.

On a molecular weight scaled basis, the NOAEC would be 120mg/m3.

(94 x 206.28) / 162.3=120 mg/m3



Repeated dose toxicity: via oral route - systemic effects (target organ) digestive: liver; other: all gross lesions and masses

Repeated dose toxicity: inhalation - systemic effects (target organ) respiratory: lung; respiratory: nose; respiratory: other

Repeated dose toxicity: dermal - systemic effects (target organ) other: skin; other: all gross lesions and masses

Justification for classification or non-classification

Based on the hazard assessment of2-(2-(2-butoxyethoxy)ethoxy)ethanol in section 2.1 and 2.2. in IUCLID 5.3., available data for the substance and following the “Guidance onInformation 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

Repeated dose toxicity

R33 Danger of cumulative effects.

T; R48/23 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation.

T; R48/23/24 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin.

T; R48/23/24/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed.

T; R48/23/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed.

T; R48/24 Toxic; Toxic: danger of serious damage to health by prolonged exposure in contact with skin.

T; R48/24/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed.

T; R48/25 Toxic; Toxic: danger of serious damage to health by prolonged exposure if swallowed.

Xn; R48/20 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation.

Xn; R48/20/21 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation and in contact with skin.

Xn; R48/20/21/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation, in contact with skin and if swallowed.

Xn; R48/20/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure through inhalation and if swallowed.

Xn; R48/21 Harmful; Harmful: danger of serious damage to health by prolonged exposure in contact with skin.

Xn; R48/21/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure in contact with skin and if swallowed.

Xn; R48/22 Harmful; Harmful: danger of serious damage to health by prolonged exposure if swallowed.

 

CLP

Repeated dose toxicity

STOT Rep. Exp. 1

STOT Rep. Exp. 2

H372: Causes damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.

H373: May cause damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.

It is concluded that the substance 2-(2-(2-butoxyethoxy)ethoxy)ethanol does not meet the criteria to be classified for human health hazards for Repeated dose toxicity