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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Remarks:
Pharma Forschung Toxikologie und Pathologie, Hoechst Aktiengesellschaft, 6230 Frankfurt 80

Test material

Constituent 1
Chemical structure
Reference substance name:
Isobutyraldehyde
EC Number:
201-149-6
EC Name:
Isobutyraldehyde
Cas Number:
78-84-2
Molecular formula:
C4H8O
IUPAC Name:
2-methylpropanal
Details on test material:
- Name of test material: Isobutanal
- Product No.: IDBY 925
- Purity ≥ 99% (with up to 0.1% water, 0.2% n-butyraldehyde and 0.3% isobutanoic acid)
- Storage: in the dark at 20°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, Kastengrund
- Age at study initiation: 3 – 5 months
- Weight at study initiation: 2.3 – 2.8 kg
- Housing: 1 animal per cage
- Diet: ad libitum Altromin 2123 (standard diet for rabbits), Altromin-FmbH, Lage/Lippe
- Water: demineralized water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air: air-conditioned
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye of the same animal
Amount / concentration applied:
0.1 mL in the conjunctival sac of the left eye
Duration of treatment / exposure:
24 h
Observation period (in vivo):
The assessments of the eyes were done 1, 24, 48 and 72 hours after application of the test substance. Additional to the assessment dates 24 and 72 hours as well as after 7 days the cornea were investigated for damages under UV light (after instillation of a drop of fluorescein/sodium solution). Since findings were observed after 72 hours, a secondary assessment was done after 7 days.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was washed off with physiological saline solution after 24 hours.

TOOL USED TO ASSESS SCORE: fluorescein
Assessment of eyes were done 1, 24, 58 and 72 hours after application of the test substance.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2
Time point:
other: 24 - 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2
Time point:
other: 24 - 72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
1.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 - 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 - 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritant / corrosive response data:
1 - 72 hours after application the conjunctiva showed clearly injected vasodilation up to diffuse strong reddening and slight swelling up to swelling with half-closed eyelid. The iris of 2 animals was occasionally reddened. These 2 animals also showed diffuse cornea opacity with easy discernible translucent areals. In addition, a clear colorless resp. white and mucous discharge was seen. All irritation effects were reversible within 7 days.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information