Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
eye 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 405 (Acute Eye 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 / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 month
- Weight at study initiation: 1.8-3.0 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

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
0,1 ml per eye
Duration of treatment / exposure:
24 h after application the eye was rinsed with physiol. saline.
Observation period (in vivo):
examinations at 1, 24, 48, 72 h, and 7d after application
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean of 24, 48, and 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 dasys
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean of 24, 48, and 72h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean of 24, 48, and 72h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritaion (corenea) at any time
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of 24, 48, and 72h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean of 24, 48, and 72h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean of 24, 48, and 72h
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of 24, 48, and 72h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean of 24, 48, and 72h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean of 24, 48, and 72h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48, and 72h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of 24, 48, and 72h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean of 24, 48, and 72h
Score:
0
Max. score:
4
Reversibility:
other: initial slight effects were fully reversible within 24 h
Irritant / corrosive response data:
At 24 h post application iris of one animal showed no reaction to light. Beside irritations occasionally a clear eye discharge occured at some animals. All signs of irritation were fully reversible within 7 days.
Other effects:
No other effects were reported.

Applicant's summary and conclusion

Interpretation of results:
other: not irritating according to DSD and irritating (category 2) according to CLP
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the findings in this test the test substance is not eye-irritating according to DSD and eye-irritating (category 2) according to CLP.
Executive summary:

Acetessigsäure-glykolester was tested for eye irritating properties according to OECD 405. Following this protocol 0.1 ml of the undiluted test substance was applied into the conjunctival sac of the left eye of three rabbits. The right eye remained untreted and served as control. After 24 h exposure time the eyes were rinsed with physiol. saline. The eyes of the animals were examined at 1, 24, 48, 72 h, and 7 days after test substance application. Mean scores (mean of 24, 48, 72 h) were calculated for cornea, iris, conjunctivae redness, and conjunctivae chemosis for each animal.

Based on the findings in this test the test substance is not eye-irritating according to DSD and eye-irritating (category 2) according to CLP.