Registration Dossier
Registration Dossier
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: 288-284-4 | CAS number: 85711-26-8
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02.02.1981-11.02.1981
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Method: Draize Test
- GLP compliance:
- yes
Test material
- Reference substance name:
- Alcohols, C9-11-branched and linear
- EC Number:
- 288-284-4
- EC Name:
- Alcohols, C9-11-branched and linear
- Cas Number:
- 85711-26-8
- Molecular formula:
- C9H20O, C10H22O and C11H24O
- IUPAC Name:
- Alcohols, C9-11-branched and linear
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Camm Research Institute, USA
- Weight at study initiation: 2.1 - 2.7 kg
- Housing: Individually housed in suspended stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average 20.9C
- Humidity (%): average 56.3
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 0.5 minute(s)
- Observation period (in vivo):
- 7 days (examination points at 1, 24, 48 and 72 hours and at 7 days)
- Number of animals or in vitro replicates:
- 3M+3F unrinsed; 3M rinsed.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM: Draize, 1963 plus Kay & Callandra 1962 (modified)
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- other: nonwashed eyes
- Time point:
- other: 24 hours
- Score:
- 8.8
- Max. score:
- 110
- Irritation parameter:
- cornea opacity score
- Remarks:
- rinsed eyes
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- rinsed eyes
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- rinsed eyes
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- rinsed eyes
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- rinsed eyes
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- rinsed eyes
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- rinsed eyes
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- rinsed eyes
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- rinsed eyes
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- rinsed eyes
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- rinsed eyes
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- rinsed eyes
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- unrinsed eyes
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- unrinsed eyes
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- unrinsed eyes
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- unrinsed eyes
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- unrinsed eyes
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- unrinsed eyes
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- unrinsed eyes
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- unrinsed eyes
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- unrinsed eyes
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- unrinsed eyes
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed eyes
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed eyes
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed eyes
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed eyes
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed eyes
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- unrinsed eyes
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- unrinsed eyes
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- unrinsed eyes
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- unrinsed eyes
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- unrinsed eyes
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- unrinsed eyes
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- unrinsed eyes
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- AVERAGE SCORE (24+48+72 hour) rinsed
- Cornea: individual scores all 0 (group mean score 0)
- Iris: Individual scores all 0 (group mean score 0)
- Conjunctivae (Redness): individual scores 0.3, 0, 0.3 (group mean score 0.2)
- Conjunctivae (Chemosis): individual scores 0.3, 0, 0.3 (group mean score 0.2)
- Overall irritation score: Maximum mean total score 4.7 at 1 hours after instillation.
All scores were 0 at 7 days both rinsed and unrinsed. - Other effects:
- Conjunctival discharge reported in some rabbits up to 48 hours post instillation (unrinsed) and 1 hour after instillation (rinsed).
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The in vivo eye irritation study for Alcohols, C9-11-branched and linear, conducted according to a protocol similar to OECD Test Guideline 405 and in compliance with GLP, concluded Alcohols, C9-11-branched and linear to be not irritating to 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.
