Registration Dossier
Registration Dossier
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EC number: 227-774-4 | CAS number: 5977-14-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- other: not adequate
- Rationale for reliability incl. deficiencies:
- other: study design does not correspond to EU classification criteria
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- a 30% dilution was tested instead of the undiluted substance
- Principles of method if other than guideline:
- a 30% dilution was tested instead of the undiluted substance
- GLP compliance:
- yes
Test material
- Reference substance name:
- Acetoacetamide
- EC Number:
- 227-774-4
- EC Name:
- Acetoacetamide
- Cas Number:
- 5977-14-0
- Molecular formula:
- C4H7NO2
- IUPAC Name:
- acetoacetamide
- Details on test material:
- - Name of test material (as cited in study report): Acetessigamidlösung ca. 30 %ig
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, breeding colony and Madörin AG, Füllingsdorf, Schweiz
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2,6 - 3,3 kg
- Housing: in air conditioned rooms in single cages
- Diet: Altromin 2123 Haltungsdiät - Kaninchen, ad libitum. 15 grams hay per day
- Water : deionized and chlorinated water from automatic suspensors, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3
- Humidity (%): 50 +- 20
- Photoperiod 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the animal
- Amount / concentration applied:
- 0,1 ml of the 30% aequous acetoacetamide-solution
- Duration of treatment / exposure:
- 24 hour
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE:
Washing with physiological saline (37 °C) 24 hours after application of the test item and before each investigation
SCORING SYSTEM:
Cornea: 0 - 4
Iris: 0 - 2
Conjunctivae: 0 - 3
Chemosis: 0 - 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: # 100, 182, 543 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (cornea) at any time
- Irritation parameter:
- iris score
- Basis:
- animal: # 100, 182, 543 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no signs of irritation (iris) at any time
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: # 100, 182, 543 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- other: no signs of irritation (conjunctivae) at any time
- Irritation parameter:
- chemosis score
- Basis:
- animal: # 100, 182, 543 each
- Time point:
- other: mean of 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no signs of irritation (chemosis) at any time
- 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, Acetessigamidlösung (ca. 30 %ig) is not irritating to the rabbit eye.
- Executive summary:
Acetessigamidlösung ca. 30 %ig was tested for eye irritating proprties according to OECD 405. Following this protocol the left eyes of three rabbits were treated with 0.1 ml of 30 % aequous acetoacetamid solution. The untreated right eyes served as control. 24 hours after instillation the treated eyes were washed with physiological saline (37°C). The examination of the eyes was performed 1, 24, 48 and 72 hours after application. No signs of irritation were observed at any time.
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