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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 291-768-8 | CAS number: 90480-35-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21.02.-01.03.1984
- 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:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2,6-Octadienal, 3,7-dimethyl-, acid-isomerized
- EC Number:
- 291-768-8
- EC Name:
- 2,6-Octadienal, 3,7-dimethyl-, acid-isomerized
- Cas Number:
- 90480-35-6
- IUPAC Name:
- 1-methyl-4-(propan-2-yl)benzene; ethanol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 - 16 weeks
- Weight at study initiation: 2.32 - 2.61kg
- Housing: individually housed in suspended metal cages
- Diet: ad libitum, laboratory diet (Rabbit Diet, A.W. Tindall Limited, Holbeach, Lincolnshire)
- Water: ad libitum, tap water
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 +/- 1.5
- Humidity (%): 55 - 65
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12
Test system
- Vehicle:
- other: arachis oil B.P.
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration
-- range fnder: 50%, 75% and 100%
-- main test: 100% - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: no
SCORING SYSTEM: Draize method
TOOL USED TO ASSESS SCORE: standard ophthalmoscope (Keeler). Observation of corneal opacity may be carried out under ultraviolet illumination (Mineralight UVSL-58) preceded by the instillation into the eye of fluorescein following the 24 hour readings, if necessary.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
Individual daily scores
| Rabbit | 1 | 2 | 3 | ||||||
| Time after treatment | 24 | 48 | 72 | 24 | 48 | 72 | 24 | 48 | 72 |
| Cornea | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Conjuctival redness | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Conjuctival chemosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item is not eye irritant.
- Executive summary:
In the current study the eye irritant effects of the test item were evaluated in a study according to OECD 405 and GLP.
In a range finding study the maximum non-irritant concentration of the test material to the eye was determined.
In the main study a concentration of 100% of the test item was applied to the right eye of 3 rabbits. The left eye served as control. Reactions were read 1, 24, 48 and 72 hours after treatment.
The test material caused irritation in all rabbits 1 hour after application, however, after 24 hours only 2 animal showed mild conjunctival inflammation. The reactions had ameliorated completely in these 2 rabbits.
The calculated mean scores at 24, 48 and 72 hours for the 3 animals were 0.0 for the cornea, 0.0 for the iris, 0.2 for the conjuctival redness and 0.0 for conjunctival chemosis.
The substance is not irritant to the eye and should not be classified.
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.
