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Eye irritation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- July 2010
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- The number of animal is not enough to let a correct classification according to CLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Hillcrest, Belton, Loughborough, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.40 or 2.42 kg
- Housing: individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum to 2030 Teklad global rabbit diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 degrees C
- Humidity (%): 30-70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 / 12 dark-light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 ml - Duration of treatment / exposure:
- Test material was applied to eye, and the eyelids were held together for about 1 second and then released. Eyes were not rinsed after exposure.
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: Eyes were not rinsed after exposure.
SCORING SYSTEM: initial pain reaction from 6-point scale, Draize scale for scoring ocular irritation was used during the observation period. After scores were assigned, a modified version of Kay and Calandra (1962) was used to classify the ocular irritancy potential.
TOOL USED TO ASSESS SCORE: ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 12
- Reversibility:
- not specified
- Remarks on result:
- other: Both test animals had scores of 12 at 1 hour, which had diminished to 6 at 24 hours. Both had a score of 0 at 48 and 72 hours.
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #69221, #69235
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #69221, #69235
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #69221
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #69235
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal: #69221, #69235
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible
- Other effects:
- Body weight changes after 3 days: +0.05 kg
Any other information on results incl. tables
Table. Individual Scores and Individual Total Scores for Ocular Irritation
|
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- The number of animal is not enough to let a correct classification according to CLP Regulation
- Conclusions:
- The test material does not seem to be an eye irritant under the test conditions
- Executive summary:
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
- OECD guidelines for the testing of chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)
- Method B.5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008
A single application of the test material to the non-irrigated eye of two rabbits produced moderate conjuctival irritation. Both treated eyes appeared normal at the 48 -Hour observation.
The test material does not seem to be an eye irritant based on the scores obtained for conjuctivae redness, chemosis, cornea and iris.
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.
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