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EC number: 270-128-1 | CAS number: 68411-46-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14/01/1983-24/01/1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non GLP (performed 1983), OECD conform, but experiment was stopped before all animals recovered
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- observation period terminated at day 7 although one animal still showed symptoms
- GLP compliance:
- no
Test material
- Reference substance name:
- Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene
- EC Number:
- 270-128-1
- EC Name:
- Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene
- Cas Number:
- 68411-46-1
- Molecular formula:
- C16H19N - C28H43N (main constituents)
- IUPAC Name:
- Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): TK 12340
- Substance type: organic
- Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983
- Measured for Batch: Density 0.976 g/ml; refraction index (20°C) = 1.571; nitrogen content 4.6%; further components quantified by gas chromatography
Constituent 1
- Specific details on test material used for the study:
- - Physical state: liquid
- Lot/batch No.: EN 65360.22.368
- Expiration date of the lot/batch: 12/1983
- Storage condition of test material: room temperature
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12 - 14 weeks
- Weight at study initiation: 2 - 3 kg
- Housing: Animals were housed individually in metal cages.
- Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 4 d
-Individual Identification: ear numbers
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/- 3
- Humidity (%): 30-70
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye untreated
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SCORING SYSTEM:
-CORNEA: non irritant = 0; slightly irritant = 1; irritant = 2; severely irritant = 3-4; corrosion = +
-IRIS: non irritant = 0; irritant = 1; severely irritant = 2; corrosion = +
-CONJUNCTIVEAE: non irritant= 0; slightly irritant = 1; irritant = 2; severely irritant = 3; corrosion = +
-CHEMOSIS: no swelling = 0; slight swellinig = 1; swelling = 2; severe swelling = 3-4
TOOL USED TO ASSESS SCORE: no data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h and 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: animal 37/m scored 1 at 1h and reversed to 0 at 24 h
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48, 72 h and 7 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 d
- Remarks:
- one animal with score of 1 on day 7
- Remarks on result:
- other: Two animals fully reversed after 7 days.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
Any other information on results incl. tables
cornea findings
| animal no. | 1 | 2 | 3 |
| 1h | 0 | 0 | 0 |
| 24h | 0 | 0 | 0 |
| 48h | 0 | 0 | 0 |
| 72h | 0 | 0 | 0 |
iris findings
| animal no. | 1 | 2 | 3 |
| 1h | 0 | 0 | 0 |
| 24h | 0 | 0 | 0 |
| 48h | 0 | 0 | 0 |
| 72h | 0 | 0 | 0 |
conjunctivae findings
| animal no. | 1 | 2 | 3 |
| 1h | 1 | 2 | 2 |
| 24h | 2 | 2 | 1 |
| 48h | 2 | 1 | 1 |
| 72h | 1 | 1 | 1 |
| 7 days | 0 | 0 | 1 |
chemosis
| animal no. | 1 | 2 | 3 |
| 1h | 1 | 0 | 1 |
| 24h | 1 | 0 | 1 |
| 48h | 1 | 0 | 1 |
| 72h | 0 | 0 | 1 |
| 7 days | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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