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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

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:
4'-methoxyacetoacetanilide
EC Number:
226-615-6
EC Name:
4'-methoxyacetoacetanilide
Cas Number:
5437-98-9
Molecular formula:
C11H13NO3
IUPAC Name:
N-[4-(methoxyacetyl)phenyl]acetamide

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, conventional breeding colony
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.2 - 3.5 kg
- Housing: air conditioned, single cages
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiät - Kaninchen, and hay, ad libitum
- Water (e.g. ad libitum): deionised, chlorinated, automatic dispenser, 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 right untreated eye served as control
Amount / concentration applied:
100 mg, left eye
Duration of treatment / exposure:
24h
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, physiol. saline
- Time after start of exposure: 24 h

SCORING SYSTEM:
CORNEA: 0-4
IRIS: 0-2
CONJUNCTIVA redness: 0-3
CONJUNCTIVA chemosis: 0-4


TOOL USED TO ASSESS SCORE: fluorescein, UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: # 80, 81, 92 each
Time point:
other: mean of 24, 48, 72 h readings
Score:
0
Max. score:
4
Reversibility:
other: reversibility not applicable since no signs of irrtation were observed at any reading time
Irritation parameter:
iris score
Basis:
animal: # 80, 81, 92 each
Time point:
other: mean of 24, 48, 72 h readings
Score:
0
Max. score:
2
Reversibility:
other: reversibility not applicable since no signs of irrtation were observed at any reading time
Irritation parameter:
conjunctivae score
Basis:
animal: # 80
Time point:
other: mean of 24, 48, 72 h readings
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal: # 81
Time point:
other: mean of 24, 48, 72 h readings
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal: # 92
Time point:
other: mean of 24, 48, 72 h readings
Score:
0.7
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: # 80
Time point:
other: mean of 24, 48, 72 h readings
Score:
0
Max. score:
4
Reversibility:
other: initial signs of chemosis were fully reversible within 24 h
Irritation parameter:
chemosis score
Basis:
animal: # 81
Time point:
other: mean of 24, 48, 72 h readings
Score:
0
Max. score:
4
Reversibility:
other: initial signs of chemosis were fully reversible within 24 h
Irritation parameter:
chemosis score
Basis:
animal: # 92
Time point:
other: mean of 24, 48, 72 h readings
Score:
0
Max. score:
4
Reversibility:
other: initial signs of chemosis were fully reversible within 24 h
Irritant / corrosive response data:
discharge fully reversible within 24 h (2 animals) or 48 h (1 animal)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item does not cause serious eye damage or eye irritation under these test conditions.

These findings do not meet criteria for a classification as eye irritant or seriously damaging to the eye according to REGULATION (EC) No 1272/2008:

Serious eye damage/eye irritation: not classsified
Executive summary:

The test item was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. During the observation period of three days no signs of serious eye damage or eye irritation were observed. All mean scores for cornea, iris, and conjunctiva chemosis were 0, mean sores for conjunctiva redness were 0.7 for two animals and 0.3 for one animal. Thus the test item does not cause serious eye damage or eye irritation under these test conditions.

under these test conditions.