Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation

No evidence of sensitisation in the study of Zissue D,1995.No adverse skin sensitisation reactions were observed. Because of the structural similarity, this result can be reliably be read across to the substance 2 -(2 -(2 -butoxyethoxy)ethoxy)ethanol.

Synopsis

Not sensitising

In other study Brake Fluid 500 DOT 4 was tested for skin sensitisation using the Guinea pig Magnusson and Kligman method. No evidence of skin sensitisation was seen in the study. Because of the structural similarity, this result can be reliably be read across to the substance 2 -(2 -(2 -butoxyethoxy)ethoxy)ethanol.

 Synopsis

Not sensitising


Migrated from Short description of key information:
No evidence of skin sensitisation. It is concluded that the substance2-(2-(2-butoxyethoxy)ethoxy)ethanol does notmeet the criteria to be classified for human health hazards for Inhalation - local effect: respiratory irritation/corrosion and/or respiratory sensitisation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Respiratory sensitisation.

In the study of Gingell R,1998, a single group of male and female guinea pigs was exposed to the maximum pratically achievable vapour concentration of 2 -butoxyethanolor 2-(2-(2-butoxyethoxy)ethoxy)ethanolthe subject of this dossier) is expected to exhibit very similar toxicityby whole body exposure for a period of 1 hour.No signs of irritation of respiratory tract were observed.

This concentration was nominally 1097ppm but the concentrations measured were 633ppm (3.1mg/l) for females and 691ppm (3.4mg/l) for males. The calculated saturated vapour pressure under ambient conditions is 791ppm. During exposure and the subsequent 14 day observation period, there were no deaths and no clinical signs of toxicity.

 Progressive body weight gain was observed. No pathological findings attributed to exposure were seen.


Migrated from Short description of key information:
No signs of respiraratory sensitisation of respiratory tract were observed and the substance would not be not sensitising for respiratory sensitisation by the inhalation route.

Justification for classification or non-classification

Based on the hazard assessment of 2-(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” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:

Directive 67/548

Respiratory Sensitisation Xn

R42 May cause sensitization by inhalation

Respiratory Irritation Xi

R37 irritating to respiratory system

CLP

Respiratory Sensitisation

H334 Resp. Sens. 1 May cause allergy or asthma symptoms or breath-ing difficulties if inhaled

Respiratory Irritation

H335 STOT SE 3 May cause respiratory irritation

It is concluded that the substance2-(2-(2-butoxyethoxy)ethoxy)ethanol does notmeet the criteria to be classified for human health hazards for Inhalation - local effect: respiratory irritation/corrosion and/or respiratory sensitisation.