Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study with basic documentation which meets basic scientific principles and contains sufficient detail to be able to judge the results reliable as a contribution to the understanding of the toxicity of this substance.

Data source

Reference
Reference Type:
publication
Title:
Comparative toxicological study of ethyl glycol acetate and butyl glycol acetate
Author:
Truhaut R, Dutertre-Catella H, Phu-Lich N, Ngoc Huyen V
Year:
1979
Bibliographic source:
Toxicol Appl Pharmac 51, 117-27

Materials and methods

Principles of method if other than guideline:
Method according to (unspecified) French regulations of 1971 which are in turn derived from the method of Draize (1959). The Draize method is the origin of the OECD test method.
GLP compliance:
not specified
Remarks:
no data

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
DETAILS OF SURROGATE SUBSTANCE

PHYSICO-CHEMICAL PROPERTIES
- Melting point: 209K
- Boiling point: 465K
- Vapour pressure: 50Pa
- Water solubility (under test conditions): 15,000mg/l
- Henry's law constant: 0.53Pa.m3/mol
- log Pow: 1.51
- pKa: no dissociatable groups
- Stability in water: Yes at neutral pH
- Stability in light: Yes
- pH dependance on stability: Yes

OTHER PROPERTIES (if relevant for this endpoint)
- Other: The surrogate material shares the same key structural features of a glycol ether with a free hydroxyl group at one end of the molecule that has been esterified with an acetic acid group and a normal butyl hydrocarbon chain at the other. The difference with this substance is that there is an extra CH2CH2O ethoxy group separating the two functional groups. The surrogate substance is likely to show a similar level of eye irritancy compared to the substance for which this dossier is prepared.

Test animals / tissue source

Species:
rabbit
Strain:
other: New Zealand (unspecified)
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
no data
Duration of treatment / exposure:
no data
Observation period (in vivo):
no data
Number of animals or in vitro replicates:
6
Details on study design:
no further data

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hrs
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
Only two of the 6 rabbits showed any response which was slight conjunctival redness and discharge in the first 24 hours. From 48hrs onwards there was no irritation observable.
Other effects:
none reported.

Any other information on results incl. tables

Use of read across to a similar substance can be justified to meet the data information requirements when data is not available for the substance itself. In this case use of the data from the substance 2 -butoxyethyl acetate (EGBEA) can be justified to assess the potential for local irritant effects, which primarily result from local hydrolysis of the substance to form acetic acid. The use of data from EGBEA can be considered part of a weight of evidence approach to fulfil the data requirements for this end point. A more detailed justification for read across for irritation is contained in a report attached to chapter 13 of this IUCLID dossier.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Substance causes slight irritation, but no sufficient for classification.
Executive summary:

In an in vivo eye irritation study in which basic details are available, 2 -butoxyethyl acetate produced only very slight irritation in a few of the exposed rabbits, manifest as mild conjunctival redness, which was fully reversed within 48 hours. The response did not meet the threshold for classification as an eye irritant.

Synopsis

Not irritating.