Registration Dossier
Registration Dossier
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EC number: 202-880-3 | CAS number: 100-70-9
Toxicological information
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979-05-22 to 1979-06-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- According to US EPA protocols 1979
- Principles of method if other than guideline:
- Local tolerance of 0.1 mL substance was tested on right eye of 9 rabbits. After an instillation time of 20-30 seconds, the eyes of 3 of the treated animals were flushed for 1 minute with a 0.9 W/V% NaCl-solution in order to remove substances residues. Respecitve left eyes remained untreated and served as control Readings of ocular lesions were made several times on the day of application, thereafter once daily at an interval of 24 hours until day 18 after application (with and without fluorescein-instillation).
- GLP compliance:
- not specified
- Remarks:
- predates GLP
Test material
- Reference substance name:
- Pyridine-2-carbonitrile
- EC Number:
- 202-880-3
- EC Name:
- Pyridine-2-carbonitrile
- Cas Number:
- 100-70-9
- Molecular formula:
- C6H4N2
- IUPAC Name:
- pyridine-2-carbonitrile
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- lot # 5257, technical grade
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Acclimitazation period of 26 days, 9 rabbits (5m, 4f). Breeder: Schriever, body weight 2.5-31.kg. Kept in metal boxes (1 rabbit/box) with wire mesh bottom in temperature (21-22 deg C) relative humidity (45-70%) and light controlled (12 hours day-night-rhythm) rooms. The animals had free access to feed (Altromin K0 and purified tap water.
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- warmed to 30 deg C to liquefy
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL substance into conjunctival sac of right eye. Upper and lower lids were then gently held together for approximately 1 second before releasing to prevent loss of material.
- Duration of treatment / exposure:
- Treated eyes of 6/9 remained unwashed. 3/9 remaining rabbits received test material and then the treated eyes were flushed for one minute with a lukewarm 0.9 W/V% NaCl-solution starting no sooner than 20-30 seconds after instillation Left eyes remained untreated and served as control.
- Observation period (in vivo):
- 18 days
- Number of animals or in vitro replicates:
- 9 rabbits
- Details on study design:
- Readings of ocular lesions made at 0.5, 1, 2, and 24 hours after treatment and at an interval of 24 hours until day 18 after treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #7
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #8
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #9
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal: #7
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- iris score
- Basis:
- animal: #7
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: #9
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #7
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #8
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #9
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal: #7
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal: #8
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- animal: #9
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 1
- Irritant / corrosive response data:
- 24 hours after treatment, the cornea of 2 animals showed a pale coloration partly or totally with fluorescein. From day 5 (7 animals) or day 17 (2 animals) after treatement the animals were free of irritation. No severe discrepancies in the irritation of the washed (3 animals after 20-30 seconds) and unwashed (6 animals) eyes were observed. The control eyes showed no reaction.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Single application of 2 -Cyanopyridine to eyes temporarily caused minor irritation of the conjunctivae, but did not meet the criteria of eye irritation under GHS.
- Executive summary:
Single application of 2 -Cyanopyridine to eyes temporarily caused minor irritation of the conjunctivae, but did not meet the criteria of eye irritation under GHS.
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