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EC number: 203-854-4 | CAS number: 111-29-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Federal Register 38 No 187 § 1500.41 ( Haut) und § 1500.42 (Auge), S. 27019 vom 27.09.73 .
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Pentane-1,5-diol
- EC Number:
- 203-854-4
- EC Name:
- Pentane-1,5-diol
- Cas Number:
- 111-29-5
- Molecular formula:
- C5H12O2
- IUPAC Name:
- pentane-1,5-diol
- Details on test material:
- - Name of test material (as cited in study report): 1,5-pentanediol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- one application
- Observation period (in vivo):
- 8 d
- Number of animals or in vitro replicates:
- 2 male, 4 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
TOOL USED TO ASSESS SCORE: fluorescein
SCORING SYSTEM:
Conjunctival redness, chemosis and corneal opacity were scored according to the below described system.
Although the results in the report were originally not given as Draize scores the data can be transferred into the Draize scoring system (in brackets). (+) = none - negligible effect (Draize score 0)
+ = slight effect (1)
++ = moderate effect (2)
+++ = severe effect (> = 3)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 3
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal 1-6
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Results:
Animal 1: female, 3.11 kg
Animal 2: female, 3.12 kg
Animal 3: male, 2.93 kg
Animal 4: male, 2.99 kg
Animal 5: female, 2.81 kg
Animal 6: female, 3.30 kg
| Readings | Animal | cornea | Iris | conjunctiva | Symptons | |||
| opacity | area | redness | swelling | discharge | ||||
| 1 h | 1 | 1 | 4 | 0 | 2 | 2 | 2 | |
| 2 | 1 | 4 | 0 | 2 | 2 | 2 | ||
| 3 | 1 | 4 | 0 | 2 | 2 | 2 | ||
| 4 | 1 | 4 | 0 | 2 | 2 | 2 | ||
| 5 | 1 | 4 | 0 | 2 | 2 | 2 | ||
| 6 | 1 | 4 | 0 | 2 | 2 | 2 | ||
| 24 h | 1 | 1 | 4 | 0 | 2 | 1 | 1 | |
| 2 | 1 | 4 | 0 | 2 | 1 | 1 | ||
| 3 | 1 | 4 | 0 | 2 | 2 | 1 | ||
| 4 | 1 | 4 | 1 | 2 | 2 | 2 | ||
| 5 | 1 | 4 | 0 | 2 | 1 | 1 | ||
| 6 | 1 | 4 | 0 | 2 | 1 | 1 | ||
| 48 h | 1 | 1 | 4 | 0 | 2 | 1 | 1 | sc |
| 2 | 1 | 3 | 0 | 1 | 0 | 1 | ||
| 3 | 1 | 4 | 1 | 1 | 1 | 1 | sc | |
| 4 | 1 | 4 | 0 | 1 | 0 | 1 | ||
| 5 | 1 | 3 | 0 | 1 | 0 | 1 | ||
| 6 | 1 | 2 | 0 | 1 | 0 | 1 | ||
| 72 h | 1 | 1 | 4 | 0 | 1 | 0 | 1 | sc |
| 2 | 1 | 3 | 0 | 1 | 0 | 0 | ||
| 3 | 1 | 4 | 1 | 1 | 0 | 1 | sc | |
| 4 | 1 | 4 | 0 | 1 | 0 | 1 | ||
| 5 | 1 | 3 | 0 | 1 | 0 | 1 | ||
| 6 | 1 | 2 | 0 | 1 | 0 | 1 | ||
| 8 d | 1 | 1 | 3 | 0 | 1 | 0 | 0 | sc |
| 2 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 3 | 0 | 0 | 0 | 0 | 0 | 0 | sc | |
| 4 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 5 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| 6 | 0 | 0 | 0 | 0 | 0 | 0 | ||
| mean 24 - 72 h | 1 | 1.0 | 4.0 | 0.0 | 1.7 | 0.7 | 1.0 | |
| 2 | 1.0 | 3.3 | 0.0 | 1.3 | 0.3 | 0.7 | ||
| 3 | 1.0 | 4.0 | 0.7 | 1.3 | 1.0 | 1.0 | ||
| 4 | 1.0 | 4.0 | 0.3 | 1.3 | 0.7 | 1.3 | ||
| 5 | 1.0 | 3.3 | 0.0 | 1.3 | 0.3 | 1.0 | ||
| 6 | 1.0 | 2.7 | 0.0 | 1.3 | 0.3 | 1.0 | ||
| mean 24 - 72 h | 1 - 6 | 1.0 | 3.6 | 0.2 | 1.4 | 0.6 | 1.0 | |
sc: scar
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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