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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well performed OECD and GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene diacetoacetate
EC Number:
226-724-9
EC Name:
Ethylene diacetoacetate
Cas Number:
5459-04-1
Molecular formula:
C10H14O6
IUPAC Name:
ethane-1,2-diyl bis(3-oxobutanoate)
Details on test material:
- Name of test material (as cited in study report): Acetessigsäure-glykolester

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 month
- Weight at study initiation: 2.1-3.0 kg
- Housing: single cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen, ad libitum, + hay (ca. 15 g daily)
- Water (e.g. ad libitum): deionised water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3
- Humidity (%): 50 +- 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml of undiluted substance were spread on a 2.5 x 2.5 cm area and covered with a cellulose lobe (2.5 x 2.5 cm) which was fixed by an adhesive plaster and covered with a semiocclusive bandage.
Duration of treatment / exposure:
4 h, after treatment remainig test substance was removed by rinsing with lukewarm tap water
Observation period:
examinations at 30-60 min, 24 h, 48 h, 72 h after the end of treatment
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: # 1, 2, 3 each
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (erythema) at any time
Irritation parameter:
edema score
Basis:
animal: # 1, 2, 3 each
Time point:
other: mean of 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (edema) at any time
Irritant / corrosive response data:
no signs of corrosion or irritation
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the findings in this test the test substance is neither skin irritating nor skin corrosing.
Executive summary:

Acetessigsäure-glykolester was tested for skin irritating or skin corrosive properties according to OECD 404. Following this protocol 0.5 ml of the undiluted test substance were applied to the shaved skin of 3 New Zealands White rabbits. After 4 h exposure time the semiocclusive patch was removed. Residual test substance was removed with lukewarm tap water. Animals were examined for signs of skin irritation and/or corrosion at 30-60 min, 24, 48, and 72 h after patch removal. Mean scores (mean of 24, 48, and 72h) were calculated for oedema and erythema for each rabbit.

Based on the findings in this test the test substance is neither skin irritating nor skin corrosing.