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EC number: - | CAS number: -
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- Irritation / corrosion
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![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo study performed prior to change in information requirements
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- of 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- of 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- of 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese MAFF Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.
- Deviations:
- no
- 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
- Stock supply of healthy adult rabbits
- Number and Sex: 3 females
- Age on day of dosing (Day 1): 40 or 41 weeks
- Weight prior to dosing (Day 1): Minimum 3.97 kg, maximum 4.09 kg
- Housing: Individual housing in plastic cages with peforated floor
- Environmental enrichment: Small soft white untreated wood blocks
- Diet : Standard laboratory rabbit diet (125 g/animal/day). In addition, dietary supplement of hay
replaced by a supplement of wholemeal bread as from 2 days prior to dose instillation.
- Water: Drinking water, ad libitum
- Acclimation period: 29 or 30 weeks prior to study start under laboratory conditions.
Routine analysis of the batch of diet used for nutrients, possible contaminants and microorganisms and of the drinking water were conducted or available at the testing facility.
ENVIRONMENTAL CONDITIONS
Air conditioned animal room set at:
- Temperature (°C): 18 ± 2°C
- Relative Humidity (%): 40 to 70%
- Photoperiod: 12 hrs artificial light per 24 hrs
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL of undiluted liquid test substance was administered into the conjunctival sac of one eye per rabbit (right eye). The contralateral eye (left eye) remained untreated to serve as a control.
- Duration of treatment / exposure:
- The eyes were not rinsed after treatment. Therefore, the treatment/exposure period was equivalent to the entire observation period following instillation or lasted until removal of the test material by physiological mechanisms, whichever happened sooner.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3 adult female rabbits
- Details on study design:
- EYE EVALUATION:
Before treatment start both eyes of each animal were investigated to ensure that there was no pre-existing corneal damage, iridial inflammation or conjunctival irritation.
One animal (the sentinel) was initially treated and in the absence of a severe effect the remaining two animals were committed to the study.
Eyes were evaluated in all animals at approximately 1, 24, 48 and 72 hours after test substance instillation adopting the numerical scoring system listed in Table 1 in the field below. Grades attained at 24, 48 and 72 hours after instillation were included in the mean gradings of ocular lesions and used for evaluation of the necessity of eye irritation/corrosion classification. As from 24 h after test substance instillation, staining with fluorescein supported the recognition of corneal lesions in female #3.
Equipment used for eye evaluation: Ophthalmoscope or pencil beam torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Corneal ulceration or opacity were not evident
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Corneal ulceration or opacity were not evident
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iridic changes were not evident
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: Iridic changes were not evident
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: Discharge
- Basis:
- mean
- Remarks:
- over 3 animals and 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.9
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- other: Discharge
- Basis:
- animal #1
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- other: Discharge
- Basis:
- animal #2
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: on one occasion mucoid
- Irritation parameter:
- other: Discharge
- Basis:
- animal #3
- Remarks:
- mean over 3 time points
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: at times mucoid
- Irritant / corrosive response data:
- In one animal (#1) ocular lesions were confined to conjunctival redness at 1, 24 and 48 hours after test substance instillation associated with chemosis and discharge at 1 hour after instillation. All of these findings were grade 1 and fully reversible. These findings were also evident in another animal (#2), but at higher severity (up to grade 2) and persisting slightly longer. In addition to conjunctival redness, chemosis and discharge, each up to grade 2, corneal opacity up to grade 2 and iritis grade 1 were recorded in the third animal (#3) all findings being reversible, as by 14 days after instillation also this animal was entirely free from ocular lesions.
- Other effects:
- Observation of the animals for defined behavioural criteria led to the conclusion that instillation of the test substance induced practically no initial pain response. Any other signs of systemic toxicity or ill health were not evident.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The outcome of the present in vivo study does not necessitate any labelling regarding eye irritation according to EU classification rules [DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008]. The findings noted were fully reversible and their incidence is within the category “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.
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