Registration Dossier
Registration Dossier
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EC number: 203-464-4 | CAS number: 107-12-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 3rd June 1980 - 4th September 1980
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The undiluted substance (0.1 mL) was instilled into one eye of New Zealand Albino rabbits. The animals were monitored over a period of 72 hours and effects on the cornea, iris and conjunctivae were recorded.
- GLP compliance:
- no
Test material
- Reference substance name:
- Propiononitrile
- EC Number:
- 203-464-4
- EC Name:
- Propiononitrile
- Cas Number:
- 107-12-0
- Molecular formula:
- C3H5N
- IUPAC Name:
- propanenitrile
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 Hours
- Observation period (in vivo):
- 72 Hours
- Number of animals or in vitro replicates:
- 6 Animals
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 2-6
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1-3, 6
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 8.1
- Max. score:
- 110
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Immediate: Discomfort was severe with pawing, thrashing about the stocks, and eyes tightly closed.
10 minutes: Moderate erythma, very slight oedema, copius discharge.
1 Hour: Moderate erythma, slight oedema, copius discharge.
24 Hours: Areas of barely perceptible corneal dullness in five instances; moderate erythma, very slight oedema in five instances, copius discharge.
48 Hours: Gradual improvement.
72 Hours: All scored zero.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not considered to be irritating to the eyes based on an in vivo eye irritation study conducted in rabbits.
- Executive summary:
In an in vivo eye irritation study New Zealand White rabbits were exposed to the substance by instillation of the undiluted substance (0.1 mL) into the eye. The eyes were examined at 1 hour, 1, 2 and 3 days post exposure. The substance produced severe discomfort with pawing, thrashing about the stocks, and eyes tightly closed and after 10 minutes threre was moderate erythma, very slight oedema and copius discharge. At 3 days, no conjunctival irritation was observed in all animals dosed. No corneal involvement or irritis was observed during after 3 days. The substance is not expected to be an eye irritant under the conditions of this study.
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