Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
other: expert assessment
Adequacy of study:
key study
Study period:
2019
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Assessment based on the properties of the indvidiual constituents of the substance

Data source

Reference
Reference Type:
other: expert assessment
Title:
Unnamed
Year:
2019
Report Date:
2019

Materials and methods

Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
An assessment was conducted based on the properties of the indvidiual constituents of the substance.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Results and discussion

In vitro

Results
Remarks on result:
other: An assessment was conducted based on the properties of the indvidiual constituents of the substance. It concluded that the substance shall be classified as Eye Dam. 1; H318.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
An assessment was conducted based on the properties of the indvidiual constituents of the substance. It concluded that the substance shall be classified as Eye Dam. 1; H318.
Executive summary:

The capacity of Phenol, ethoxylated to be irritant to the eye was assessed based on the available information on its constituents.

2-phenoxyethanol is classified as Eye Irrit 2; H319 and 2-(2-phenoxyethoxy)ethanol as Eye Dam. 1; H318 based on available experimental data.

Considering the structural similarities between the constituents of Phenol, ethoxylated and in the absence of experimental data on the substance, 2-[2-(2-phenoxyethoxy)ethoxy]ethanol can be expected to be damaging to the eye.

It is concluded that Phenol, ethoxylated does not meet the criteria for classification as irritant to the eye according to the CLP Regulation. However, it is proposed to conduct testing on the substance in order to confirm the conclusion.

In accordance with the CLP Regulation, since the concentration of constituents of Phenol, ethoxylated classified as damaging to the eye is above 3%, the substance shall be classified as Eye Dam. 1; H318.