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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 Mai 1989 - 2 June 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Acetoacetamide
EC Number:
227-774-4
EC Name:
Acetoacetamide
Cas Number:
5977-14-0
Molecular formula:
C4H7NO2
IUPAC Name:
acetoacetamide
Test material form:
liquid
Details on test material:
Storage: in the dark at 4°C

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:
yes, concurrent no treatment
Amount / concentration applied:
0,1 ml of the 30% aequous acetoacetamide-solution
Duration of treatment / exposure:
24 hours
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:
other: animal # 100, 182 and 543
Remarks:
each
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
other: animal # 100, 182 and 543
Remarks:
each
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
other: animal # 100, 182 and 543
Remarks:
each
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
other: animal # 100, 182 and 543
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Other effects:
No other effects reported

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
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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