Registration Dossier

Administrative data

Description of key information

The toxicity data available are considered sufficient on irritation/corrosiveness. 
2-(2-(2-butoxyethoxy)ethoxy)ethanol is not irritating to skin, irritating to eyes and not irritating to respiratory system.
According to the EU’s list of dangerous substances (OJEC No L200/130.7.99), 2-(2-(2-butoxyethoxy)ethoxy)ethanol requires a label, R41 Risk of serious damage to eyes, which is consistent to the data obtained.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin Irritation

In an old, well reported skin irritation study that followed the basic principles of the current OECD guideline, White Vienna rabbits were used. 2 animals were treated for 20 hours to the substance 2-(2-(2-butoxyethoxy)ethoxy)ethanol under occlusive conditions. No adverse skin reaction was seen. On this basis, the substance does not warrant classification as a skin irritant.

In a well reported skin irritancy study, the test substance 2-(2-(2methoxyethoxy)ethoxy)ethanol 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 to2-(2-(2-methoxyethoxy)ethoxy)ethanolwas applied under occluded conditions to rabbit skin for exposure periods of up to 20 hours.

 The test substance was then washed before observing the animals for a period of up to 8 days. Mild erythema was seen in one of the two test animals but odema was not reported. Effects disappeared within 48 hours. On the basis of these results the substance is not regarded as a skin irritant.

In a guideline skin irritation study, the substancePolyethylene glycol methyl ether or 2-(2-(2-butoxyethoxy)ethoxy)ethanolthe subject of this dossier) is expected to exhibit very similar toxicity due to its close structural similarity toPolyethylene glycol methyl ether caused no irritation over the observation period 24 -72 hours following application of the substance.

 

Eye Irritation

In a guideline OECD 405 eye irritancy study, a substance meeting the description "Ethanol, 2-butoxy- , manufacture of, by-products from" produced marked irritation in rabbit eyes. The most severe reaction was conjunctival erythema, which averaged a response of 2.7 across all animals tested and the 24, 48 and 72 hour observations. This reaction is sufficiently severe to warrant classification as an eye irritant. Whilst the way the subsequent observations were reported is not entirely clear, it would appear that most effects had disappeared within 14 days apart from possibly slight conjunctival redness in one animal only. On the basis of these results, the substance does not warrant classification as a severe eye irritant.

An old study used a Draize based method to assess the eye irritation potential of 2-(2-(2-butoxyethoxy)ethoxy)ethanol .

A test score of 5 was reached, indicating that the test material caused severe eye irritation.

The study reported a moderate to high level of irritation using its scoring system.

In an old eye irritation study in rabbits for which only basic results are available, 2-(2-(2-butoxyethoxy)ethoxy)ethanol produced severe redness, edema and opacity which persisted for 8 days. After 8 days, scars were visible (eyelid vessels were considerably injected). Eye signs (redness, edema, opacity and scar) were scored from slight to very severe. These high scores suggest that the immediate acute response was probably strong enough to warrant classification as a severe eye irritant (R41 or H318).

In the study performed according to OECD guideline 405, rabbits were instilled with 2 -butoxyethanolor 2-(2-(2-butoxyethoxy)ethoxy)ethanolthe subject of this dossier) is expected to exhibit very similar toxicity. Animals were observed for 21 days. Eye washing was performed about 24 hours after treatmnent, before the 24 hour reading. This practice is optional in the guideline but is considered more representative of human exposure, where lachrymation will create a washing action. One animal exhibited a slight corneal opacity reversible in 21 days. Signs of a slight iris injury was described, reversible in 7 days. A medium to severe irritation of the conjunctivae was also observed and was reversible in 21 days. According to criteria for assessment of ocular lesions, 2 -butoxyethanol can be considered as an eye irritant.

According to the EU’s list of dangerous substances (OJEC No L200/130.7.99),2-(2-(2-butoxyethoxy)ethoxy)ethanol requires a label,  R41 Risk of serious damage to eyes, which is consistent to the data obtained.

Respiratory irritation

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.

 



Effects on eye irritation: irritating

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

Skin Corrosivity C

R35 Causes severe burns

R34 Causes burns

Skin Irritation Xi

R38 Irritating to skin

R43 May cause sensitization by skin contact

Eye Irritation (Ocular Lesions) Xi

R36 Irritating to eyes

R37 irritating to respiratory system

R41 Risk of serious damage to eyes

CLP

 

Skin Corrosivity 

H314 Skin Corr 1A Causes severe skin burns and eye damage

H314 Skin Corr 1B Causes severe skin burns and eye damage

Skin Irritation 

H315 Skin Irrit. 2 Causes skin irritation

H317 Skin Sens. 1 May cause an allergic skin reaction

Eye Irritation (Ocular Lesions) Xi

H319 Eye Irrit. 2 Causes serious eye irritation

H318 Eye Dam. 1 Causes serious eye damage

H335 STOT SE 3 May cause respiratory irritation

 

It is concluded that the substance2-(2-(2-butoxyethoxy)ethoxy)ethanolmeet the criteria to be classified for human health hazards for Dermal-local effect:R41 Risk of serious damage to eyes, Eye Damage 1, H318: Causes serious eye damage.