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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-630-6 | CAS number: 108-93-0
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:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cyclohexanol
- EC Number:
- 203-630-6
- EC Name:
- Cyclohexanol
- Cas Number:
- 108-93-0
- Molecular formula:
- C6H12O
- IUPAC Name:
- cyclohexanol
- Test material form:
- not specified
- Details on test material:
- Supplier: Fluka AG, Switzerland.
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Fluka AG, Switzerland
- Purity: 99%
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Dörröds Djur- och Foderservice, Veberöd (Sweden)
- Housing: Individual housing
- Diet (e.g. ad libitum): A controlled amount of feed (Ewos avelsfoder för kanin, Batch nr 3, Ewos AB, Södertälje, Sweden)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C- Humidity (%): 50 +/- 20%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 4s, 30s, 24h
- Observation period (in vivo):
- 1h, 24h, 48h, 72 h, 10d and 21d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing with water
- Time after start of exposure: 4s, 30s, 24h
SCORING SYSTEM:
- Draize
TOOL USED TO ASSESS SCORE:
- ophthalmoscope, biomicroscope, fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- (24h exposure)
- Basis:
- mean
- Remarks:
- for each of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Remarks on result:
- other: Mean (24,48; 72h) scores of each animal: animal #1 = 1.7; animal #2 = 2; animal #3 = 2
- Irritation parameter:
- iris score
- Remarks:
- (24h exposure)
- Basis:
- mean
- Remarks:
- for each of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- (24h exposure)
- Basis:
- mean
- Remarks:
- for each of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 2.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- chemosis score
- Remarks:
- (24h exposure)
- Basis:
- mean
- Remarks:
- for each of 3 animals
- Time point:
- 24/48/72 h
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
Any other information on results incl. tables
As the erythema and oedema scores resulting from the 4-sec-exposure are less relevant for an assessment of the eye irritating property of the substance, the details are not reported here.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- In this in vivo study on rabbits, the results indicate that the test item is irritating to the eyes of rabbits.
- Executive summary:
In this GLP compliant OECD 405 study, one eye of each of 3 rabbits was treated with 0.1 mL cyclohexanol (purity 99%) for a period of 24h, 30s or 4s. Draize scoring of eye changes were performed at 24h, 48h, 72h after instillation. Regarding the 24 hour application, the mean cornea score (all animals, mean of 24 - 72 hour readings) was 1.9 (one animal with a score of 1.7 and two animals with a score of 2.0), the mean iris score was 0, the mean conjuctivae score was 2.1 (one animal with a score of 2.3 and two animals with 2.0) and the mean chemosis score was 2,3 (one animal with a score of 2,3, one with 2,7 and one with 2.0). Effects were reversible within 10 days in all animals.
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.
