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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1944
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This is a very old study that does not meet the full requirements of current OECD guidelines (not all end points reported). Nevertheless, it is reported in some detail and the method followed forms the basis for current testing methods. It is therefore considered a reliable contribution to understanding the acute dermal toxicity of this substance.

Data source

Reference
Reference Type:
publication
Title:
Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes
Author:
Draize JH, Woodward G, Calvery HO
Year:
1944
Bibliographic source:
J Pharmac exp Ther, 82, 377

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Study pre-dates guidelines but the methodology is the early forerunner to the guideline method.
GLP compliance:
no
Remarks:
pre-dates guidelines

Test material

Constituent 1
Chemical structure
Reference substance name:
2-(2-butoxyethoxy)ethyl acetate
EC Number:
204-685-9
EC Name:
2-(2-butoxyethoxy)ethyl acetate
Cas Number:
124-17-4
Molecular formula:
C10H20O4
IUPAC Name:
2-(2-butoxyethoxy)ethyl acetate
Details on test material:
no data. Referred to as diethylene glycol monobutyl ether acetate

Test animals

Species:
rabbit
Strain:
other: albino, no further data
Details on test animals or test system and environmental conditions:
No data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: both abraded and non-abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: No negative control but a number of other substances also tested concurrently
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
24 hours
Observation period:
72 hours. Measurements reported at 24 and 72 hrs
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5cmx2.5cm
- Type of wrap if used: rubberised cloth

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
0.7
Max. score:
8
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: non abraded skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
8
Reversibility:
fully reversible
Remarks on result:
other: Non abraded skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24 h
Score:
1.3
Max. score:
8
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Abraded skin
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
8
Reversibility:
fully reversible
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
Individual animal data reported: For non abraded skin, one animal had a PDII of 2 at time point 24hrs, all other animals and time points had a PDII of 0. The authors considered a PDII less than 2 as being indicative of mild irritation only

Any other information on results incl. tables

Whilst it is not possible to compare the results directly to the irritancy classification criteria, a semi-quantitive assessment strongly suggests that it would not meet the necessary triggers that would require classification as a skin irritant.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Not irritating to the skin
Executive summary:

In an old in vivo skin irritation study, 2 -(2 -butoxyethoxy)ethyl acetate produced only very slight irritation in some of the exposed rabbits which was fully reversed within 72 hours. The study did not meet the full requirements of current OECD guideline but the methodology and results are reported in some detail and the method followed forms the basis for current testing methods.Whilst exact matching of the results against classification criteria was not possible, they strongly suggested that the response did not meet the threshold for classification as a skin irritant.

Synopsis

Not irritating.