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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is comparable to OECD Guideline 405 with acceptable restrictions (partly limited documentation; 50 μl instead of 100 μl test substance instilled )

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1969
Report date:
1969
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
50 μl instead of 100 μl test substance instilled
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentan-3-one
EC Number:
202-490-3
EC Name:
Pentan-3-one
Cas Number:
96-22-0
Molecular formula:
C5H10O
IUPAC Name:
pentan-3-one
Details on test material:
- Name of test material (as cited in study report): Diaethylenketon
- Physical state: liquid
- Analytical purity: 99.8%

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Breeder
- Weight at study initiation: 2,17 - 2.67 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µL
Duration of treatment / exposure:
Treatment was once. The eye was left unwashed.
Observation period (in vivo):
8 d
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not performed


SCORING SYSTEM: Descriptive scores of the raw data have been converted to Draize numerical scores.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8, 7, or 5 days (animal #1, #2 or #3, respectively)
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 5, 7, or 5 days (animal #1, #2 or #3, respectively)
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Animal  Reading  Opacity Iritis Redness Chemosis Comment
1 24 h 1 0 1 1  
2 24 h 1 0 1 1  
3 24 h 1 0 1 1  
1 48 h 1 0 1 0  
2 48 h 1 0 1 0  
3 48 h 1 0 1 0  
1 5 d 1 0 0 0 reading after fluorescein application
2 5 d 1 0 1 0  
3 5 d 0 0 0 0 reading after fluorescein application
1 7 d 1 0 0 0 reading after fluorescein application
2 7 d 0 0 0 0 reading after fluorescein application
3 7 d 0 0 0 0 reading after fluorescein application
1 8 d 0 0 0 0 reading after fluorescein application
mean 24 - 48 h 1.00 0.00 1.00 0.50  

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Executive summary:

In a primary eye irritation study (BASF AG, Department of Toxicology, 1969), 50 µl of undiluted Diethyl ketone was instilled into the conjunctival sac of one eye of 3 White Vienna rabbits. The eyes were not washed out after 24 hours. Animals were observed for 8 days. After 24 hour, slight erythema, slight edema as well as slight corneal opacity were observed. Next observation was made after 48 hours after application. No observation was performed after 72 hours. The mean value of the scores at the 24- and 48-hour reading for erythema, edema, corneal opacity and chemosis calculated overall the animals tested was 1.0, 0.5, 1.0 and 0.0, respectively. The observed changes were fully reversible in all animals within 48 h (edema), 7 days (erythema), and 8 days (corneal opacity).

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