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EC number: 300-496-1 | CAS number: 93940-97-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-07-26 to 2005-11-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan MAFF Testing Guideline of 12 Nousan No. 8147, November 24, 2000 as this is in line with OECD 405
- Version / remarks:
- 2000
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-[[3-[[(2-cyanoethyl)amino]methyl]-3,5,5-trimethylcyclohexyl]amino]propiononitrile
- EC Number:
- 300-496-1
- EC Name:
- 3-[[3-[[(2-cyanoethyl)amino]methyl]-3,5,5-trimethylcyclohexyl]amino]propiononitrile
- Cas Number:
- 93940-97-7
- Molecular formula:
- C16H28N4
- IUPAC Name:
- 3-[(3-{[(2-cyanoethyl)amino]methyl}-3,5,5-trimethylcyclohexyl)amino]propanenitrile
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: V3186/11
Letter of Confirmation: CAS No 90530-15-7 and 93940-97-7 refer to the same substance and substance composition.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A., 01540 Vonnas, France
- Age at study initiation: 3 - 4 months
- Weight at study initiation: 2 .79 kg - 3 .18 kg
- Housing: single housing, Stainless steel wire mesh cages with grating, floor area: 3000 cm2
- Diet: Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung "GLP"), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 -70
- Air changes: fully air conditioned rooms
- Photoperiod (hrs dark / hrs light): 12 h light (6.00 a.m. - 6.00 p.m.) 12 h darkness (6.00 p.m . - 6.00 a.m.)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL - Duration of treatment / exposure:
- About 24 hours after application of the liquid test substance the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Observation period (in vivo):
- Readings: Approx. 1, 24, 48 and 72 h after application and then in weekly intervals maximally up to day 28.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: rinsing with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe
- Time after start of exposure: 24 h
SCORING SYSTEM: according to guidelines. The evaluation is based on the criteria of Annex VI of the Commission Directive 67/548/EEC that were in place on the date of report signature.
TOOL USED TO ASSESS SCORE: illumination used for reading: Daylight tubes "Lumilux" (L 58W/860 PLUS ECO 25X1, Osram, Germany)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
Table 1. Individual Scores
Readings |
Animal |
Cornea |
Iris |
Conjunctiva |
Additional findings |
|||
opacity |
Area of cornea involved |
redness |
chemosis |
Discharge |
||||
1 h |
01 |
0 |
0 |
0 |
2 |
2 |
2 |
49 |
02 |
0 |
0 |
0 |
2 |
2 |
2 |
|
|
03 |
0 |
0 |
0 |
2 |
2 |
2 |
49 |
|
24 h |
01 |
1 |
4 |
1 |
2 |
2 |
1 |
PC, 48 |
02 |
1 |
4 |
1 |
1 |
1 |
2 |
PC, 48 |
|
03 |
1 |
4 |
1 |
2 |
2 |
1 |
PC, 48 |
|
48 h |
01 |
1 |
3 |
1 |
1 |
1 |
1 |
PC, 48 |
02 |
1 |
3 |
0 |
1 |
1 |
0 |
PC, 48 |
|
03 |
1 |
3 |
0 |
2 |
2 |
1 |
PC, 48 |
|
72 h |
01 |
1 |
2 |
0 |
1 |
1 |
0 |
PC, 48 |
02 |
1 |
2 |
0 |
1 |
1 |
0 |
PC, 48 |
|
03 |
1 |
2 |
0 |
1 |
1 |
0 |
PC, 48 |
|
7 d |
01 |
0 |
0 |
0 |
0 |
0 |
0 |
|
02 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
03 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
Mean 24 – 72 h |
01 |
1.0 |
|
0.7 |
1.3 |
1.3 |
|
|
02 |
1.0 |
|
0.3 |
1.0 |
1.0 |
|
|
|
03 |
1.0 |
|
0.3 |
1.7 |
1.7 |
|
|
|
Mean |
|
1.0 |
|
0.4 |
1.3 |
1.3 |
|
|
Explanation of findings:
PC = Pupil contracted
48 = Scleral vessels injected, circumscribed area
49 = Scleral vessels injected, circular
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
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