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EC number: 421-300-1 | CAS number: 138564-59-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996-04-24 to 1996-04-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Guidelines, Annex V Methods
- Version / remarks:
- Directive 92/69/EEC of 31 July 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 421-300-1
- EC Name:
- -
- Cas Number:
- 138564-59-7
- Molecular formula:
- C12H9N3O2S
- IUPAC Name:
- 5-methyl-2-[(2-nitrophenyl)amino]thiophene-3-carbonitrile
- Test material form:
- solid: particulate/powder
- Details on test material:
- 97.7%
Item code QA405K
Lilly lot no: 356MO1
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor and 356M01
- Purity test date: 1995-03-31
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At ambient temperature in the dark
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:
- Age at study initiation:
- Weight at study initiation: 1.96-2.08 kg
- Housing: Individually in aluminium cages ( dimensions 48 x 61 x 46 cm) with grid floors beneath which were absorbent paper lined trays. Paper was changed weekly.
- Diet (e.g. ad libitum): Standard Rabbit Diet, supplied by Special Diets Services Limited, 1 Stepfield, Witham, Essex, CM8 3AD, was available ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: >42 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-24
- Humidity (%): 40-70
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- 1-2 s
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
Acute Eye Irritation Test in Rabbits Scoring System:
CORNEA
Opacity: Degree of Density (area most dense taken for reading):
No ulceration or opacity 0
Scattered or diffuse area of opacity (other than slight dulling of normal lustre), details of iris clearly visible I
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
IRIS
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcomeal hyperaemia or injection, any of these or combination of any thereof,
iris still reacting to light (sluggish reaction is positive) I
No reaction to light, haemorrhage, gross destruction (any or all of these) 2
CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
Blood vessels normal 0 Some blood vessels definitely hyperaemic (injected) I
Diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3
Chemosis (lids and/or nictitating membranes)
No swelling 0
Any swelling above normal (including nictitating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
DISCHARGE
No discharge 0
Slight discharge 1
Moderate discharge 2
Severe discharge 3
TOOL USED TO ASSESS SCORE: hand held magnifier and pen torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- ca. 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- ca. 0
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Remarks on result:
- other: Redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- ca. 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: Redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- ca. 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: redness
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Remarks on result:
- other: redness
- Irritation parameter:
- other: Discharge
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- ca. 2
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Discharge
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- other: Discharge
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- ca. 1
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Discharge
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- other: Discharge
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- ca. 1
- Reversibility:
- fully reversible
- Irritation parameter:
- other: Discharge
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- ca. 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Irritant / corrosive response data:
- No corneal or iridal responses were observed for any animals throughout the observation period.
- Other effects:
- Animal No. 1, held its head to the side immediately post dose. Moderate discharge was also noted up to 1 hour after instillation of the test material.
Animal Nos. 2 and 3 had slight conjunctiva! redness and slight discharge up to 1 h after instillation of the test material.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This study found that the test substance is not classified as an eye irritant according to GHS criteria.
- Executive summary:
Testing was carried out in accordance with OECD guideline 405 and EEC guidelines, Annex V Methods. The acute eye irritation potential of the test material was investigated in 2 New Zealand White rabbits. No corneal or iridal responses were noted for any of the animals throughout the observation period.
Animal No. 1, held its head to the side immediately post dose. Moderate discharge was also noted up to 1 hour after instillation of the test material.
Animal Nos. 2 and 3 had slight conjunctiva! redness and slight discharge up to 1 h after instillation of the test material.
Under the conditions of the study, intermediate 290437 is practically non-irritant to rabbit eyes.
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