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EC number: 914-459-8 | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 25 FEB 1997 to 7 MAR 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (EU B5/OECD 405), for justification of read-across see Chapter 1 of CSR
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Montan waxes, Type E
- IUPAC Name:
- Montan waxes, Type E
- Reference substance name:
- Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Montan wax
- EC Number:
- 914-475-5
- Molecular formula:
- R-CH2-COOR1OOC-CH2-R mainly
- IUPAC Name:
- Reaction mass of Fatty acids, montan-wax and Fatty acids, montan-wax, ethylene esters and Montan wax
- Details on test material:
- - Name of test material (as cited in study report): Hoechst Wachs E
- Substance type: light yellow substance
- Physical state: solid
- Storage condition of test material: darkness at room temperature in a fume cupboard
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation:
- Weight at study initiation: 2.4-3.1 kg
- Housing: individually
- Diet: ssniff K-H (V2333) ad libitum)
- Water: ad libitum
- Acclimation period: 1 week under study conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- 100 mg of test substance
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 1, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): with isotonic saline at approx. 37 °C
- Time after start of exposure: 24 h, at all other examination time points at which treated eyes showed discharge and after fluorescein treatment
SCORING SYSTEM: according to guidelines
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0.22
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: Redness; individual mean scores: 0.00; 0.33; 0.33, the maximum score observed was 1.0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-48-72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: grade 1 chemosis was observed at 1.1 h post exposure
- Other effects:
- All 3 animals showed a clear, colourless discharge 1-1.1 h after end of exposure (grade 2, moistening of lids and hairs adjacent to the lids). No discharge was observed at 24 h post exposure.
Any other information on results incl. tables
The maximum conjunctivae score of the 3 tested animals at 1-1.1 h after end of exposure was 1, 2 and 2, respectively. The maximum chemosis score at 1-1.1 h after end of exposure was 1 in all tested animals.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The undiluted test substance was not irritating to the eyes of rabbits.
- Executive summary:
The undiluted test substance (Hoechst Wachs E) was applicated to the eyes of 3 rabbits and removed 24 h later. The treatment caused a slight, transient reddening of the conjunctiva (mean score for 24-48-72 h: 0.22), but no iris effects, cornea opacity or chemosis. All 3 animals showed a clear, colourless discharge 1.1 h after end of exposure (grade 2, moistening of lids and hairs adjacent to the lids). No discharge was observed at 24 h post exposure.
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