Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-01-09 to 1985-04-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Conduction and documentation of study very acceptable. Study report available.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985
Reference Type:
publication
Title:
The acute toxicity and primary irritancy of 2,4-pentanedione
Author:
Ballantyne, B., Dodd, D.E., Myers R.C., Nachreiner, D.J.
Year:
1986
Bibliographic source:
Drug and Chemical Toxicology, 9, 133-146

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as stated in report
Deviations:
no
Principles of method if other than guideline:
Method: 6 female New Zealand White rabbits tested; effects scored according to Draize (1944). 0.1 ml of undiluted test substance was applied to the eyes of rabbits.
Male or female New Zealand White rabbits are dosed with 0.1 ml by instilling into the lower conjunctival sac of one eye per animal. Teh eyelids are held together for one second. Six eyes are dosed per test volume.The eyes are scored by the Draize Scoring system (Values 0 - 4 for cornea opacity and area involved, chemosis; 0-3 for redness and discharge; 0-2 for Iris) at 1, 4, 24, 48, 72 h and 7 days after dosing. Flourecein (2%) staining is used to determine corneal injury before dosing and at reading after one day.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,4-Pentanedione
- Substance type: industrial chemical
- Physical state: liquid
- Analytical purity: > 99%
- Impurities (identity and concentrations): not reported
- Lot/batch No.: 496500
- Expiration date of the lot/batch: not given
- Stability under test conditions: stable
- Storage condition of test material: not given

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
Amount applied: 0.1 ml
Duration of treatment / exposure:
no wasing of the eys
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: Draize System


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: all
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 - 4 hours
Score:
>= 0.2 - <= 0.8
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 - 4 hours
Score:
>= 0.8 - <= 1.3
Max. score:
2
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 - 4 hours
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
Slight redness of the conjunctivae was observable in 5/6 animals (average score 0.8); slight chemosis in 2/6 and moderate chemosis in 1/6 animals (average score 0.7); slight discharge in 2/6 and moderate discharge in 3/6 animals (average score 1.3); slight inflammation of the iris in 2/6 animals (average score 0.3);
Results 4 h after application of the material: Slight inflammation of the iris in 1/6 animals (score 0.2); Slight redness of the conjunctivae in 4/6 animals (average score 0.7); slight chemosis in 2/6, moderate chemosis in 1/6 animals (average score 0.7); slight conjunctival discharge in 3/6 and moderate conjunctival discharge in 2/6 animals (average score 1.2)
24 hours post-instillation all eyes healed. Opacities of the cornea were not observable at any time.
Other effects:
none reported

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Classification: not irritating
Executive summary:

6 Female New Zealand White rabbits were tested in an eye irritation test according to Draize (1944). 0.1 ml of undiluted 2,4-Pentanedione is dosed by instilling into the lower conjunctival sac of one eye per animal. The eyelids are held together for one second. The eyes are scored by the Draize Scoring system (Values 0 - 4 for cornea opacity and area involved, chemosis; 0-3 for redness and discharge; 0-2 for Iris) at 1, 4, 24, 48, 72 h and 7 days after dosing. Flourecein (2%) staining is used to determine corneal injury before dosing and at reading after one day. Results 1 h after application of the material show slight redness of the conjunctivae was observable in 5/6 animals (average score 0.8); slight chemosis in 2/6 and moderate chemosis in 1/6 animals (average score 0.7); slight discharge in 2/6 and moderate discharge in 3/6 animals (average score 1.3); slight inflammation of the iris in 2/6 animals (average score 0.3). Results 4 h after application of the material show slight inflammation of the iris in 1/6 animals (score 0.2); Slight redness of the conjunctivae in 4/6 animals (average score 0.7); slight chemosis in 2/6, moderate chemosis in 1/6 animals (average score 0.7); slight conjunctival discharge in 3/6 and moderate conjunctival discharge in 2/6 animals (average score 1.2). 24 hours post-instillation all eyes healed. Opacities of the cornea were not observable at any time. The substance did produce only slight effects (iritis and minor conjunctival irritation) not relevant for classification.