Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
