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EC number: 203-731-5 | CAS number: 110-03-2
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: well-documented, guideline-conform, but non-GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,5-dimethylhexane-2,5-diol
- EC Number:
- 203-731-5
- EC Name:
- 2,5-dimethylhexane-2,5-diol
- Cas Number:
- 110-03-2
- Molecular formula:
- C8H18O2
- IUPAC Name:
- 2,5-dimethylhexane-2,5-diol
- Details on test material:
- - Name of the test substance used in the study report: 2,5-Dimethylhexandiol-2,5
- Analytical purity: 99.5%
- Lot/batch No.: 21922-108
- Stability under test conditions: yes
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- One animal per cage (stainless steel with mire mesh walk floors (40 x 51 cm), no bedding).
The rabbits were identified via ear tattoo.
They were housed in fully air-conditioned rooms with a temperature ranging between 20 - 24°C and a relative humidity of 30 - 70%. The day/night rhythm was 12 h dark and 12 h light.
The animals were offered a standardized animal laboratory diet (ca. 130 g/animal/day) as well as about 250 ml tap water/animal/day.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml bulk volume
- Concentration (if solution): 40 mg/0.1 ml
- Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 21 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no washing performed
SCORING SYSTEM: according to OECD Guideline 405; Calculation of the mean according to 83/467/EEC Criteria of July 29th, 1983, only the readings of 24, 48 and 72 hrs were used
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 15 d
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 d
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1.8
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 21 d
Any other information on results incl. tables
| Cornea | Iris | Conjunctiva | ||||||
| Animal | Reading | Opacity | Area involved | Redness | Chemosis | Discharge | Comment | |
| 1 | 1 hrs | 0 | 0 | 0 | 2 | 2 | 2 | |
| 2 | 1 hrs | 0 | 0 | 0 | 2 | 2 | 3 | |
| 3 | 1 hrs | 0 | 0 | 0 | 2 | 2 | 2 | PC |
| 1 | 24 hrs | 1 | 2 | 1 | 3 | 3 | 2 | PC/SR |
| 2 | 24 hrs | 1 | 2 | 0 | 2 | 2 | 2 | PC/SR |
| 3 | 24 hrs | 1 | 4 | 0 | 2 | 2 | 2 | PC/SR |
| 1 | 48 hrs | 1 | 2 | 1 | 3 | 2 | 3 | PC/SR |
| 2 | 48 hrs | 1 | 2 | 0 | 2 | 2 | 1 | PC/SR/LC |
| 3 | 48 hrs | 1 | 4 | 0 | 2 | 1 | 1 | PC/SR |
| 1 | 72 hrs | 1 | 2 | 1 | 3 | 2 | 2 | PC/SR |
| 2 | 72 hrs | 1 | 1 | 0 | 2 | 1 | 0 | PC/SR/LC |
| 3 | 72 hrs | 1 | 2 | 0 | 2 | 1 | 1 | PC/SR |
| 1 | 8 d | 1 | 1 | 1 | 2 | 1 | 2 | PC/SR/LC |
| 2 | 8 d | 0 | 0 | 0 | 1 | 0 | 0 | PC/SR |
| 3 | 8 d | 0 | 0 | 0 | 1 | 0 | 0 | PC/SR |
| 1 | 15 d | 0 | 0 | 1 | 2 | 1 | 2 | PC/SR |
| 2 | 15 d | 0 | 0 | 0 | 0 | 0 | 0 | SR |
| 3 | 15 d | 0 | 0 | 0 | 0 | 0 | 0 | SR |
| 1 | 21 d | 0 | 0 | 1 | 2 | 1 | 1 | PC/SR |
| 2 | 21 d | 0 | 0 | 0 | 0 | 0 | 0 | SR |
| 3 | 21 d | 0 | 0 | 0 | 0 | 0 | 0 | SR |
| mean 1 | 24/48/72 h | 1 | 1 | 3 | 2.3 | |||
| mean 2 | 24/48/72 h | 1 | 0 | 2 | 1.7 | |||
| mean 3 | 24/48/72 h | 1 | 0 | 2 | 1.3 | |||
| mean 1/2/3 | 24/48/72 h | 1.0 | 0.3 | 2.3 | 1.8 | |||
| PC = pupil contracted | ||||||||
| SR = small retraction in the eyelid | ||||||||
| LC = loss of corneal tissue | ||||||||
Applicant's summary and conclusion
- Conclusions:
- Based on the available data, the test substance showed irreversible effects on the eyes after application to the conjuntival sac of rabbits.
- Executive summary:
The test substance was applied into the conjunctival sac of the right eyelid. Since the substance was not washed out, the test substance showed irreversible effects on the eyes.
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