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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:
1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP-study comparable to OECD guideline 405 with acceptable restrictions
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
Concentration not specified, test conditions insufficient described
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Source: Solvents and Coatings Materials, South Charleston, WV
- Name of test material (as cited in study report): Diisobutyl Ketone
- Physical state: Clear non-viscous, liquid;slightly yellow, transparent non-viscous liquid.
- Analytical purity: No data
- Lot/batch No.: 475010-135-500564

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.005, 0.01 and 0.1mL
- Concentration (if solution): As supplied


Duration of treatment / exposure:
7 days without washout
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6/volume
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: No


SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: 2% fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 0.1mL
Irritation parameter:
iris score
Basis:
mean
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: 0.1mL
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: average 24, 48 and 72h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 0.1mL
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: average 24, 48 and 72h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 0.1mL
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 0.01mL
Irritation parameter:
iris score
Basis:
mean
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Remarks on result:
other: 0.01mL
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
other: 0.01mL
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: average 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: 0.01mL
Irritant / corrosive response data:
Scores for 0.005mL were not reported due to missing effects at 0.01mL

Any other information on results incl. tables

Diisobutyl Ketone (DIBK) showed only minor irritation in rabbit eyes after instillation of 0.1mL test material that was fully reversible within 7 days. Diisobutyl Ketone has not to be classified according to DSD and CLP. However the concentration of the received test substance had not been reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean scores for cornea, iris, conjunctivae and chemosis over all animals at 24, 48 and 72 hours were below 0.5. Hence, no classification according to DSD and CLP is required for diisobutyl ketone.