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EC number: 943-492-0 | CAS number: -
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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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 October 2006 - 13 December 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF Guidelines (2000)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
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, Horst, The Netherlands
- Age at study initiation: at least 6 weeks
- Weight at study initiation: at least 1.0 kg
- Housing: animals were housed individually in labelled cages with perforated floors
- Diet: ca. 100 g per day of pelleted diet for rabbits (K-H from SNIFF® Spezialdiäten GmbH, Soets, Germany). Hay was provided at least three times a week.
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9 - 22.1 °C
- Humidity (%): 43 - 69 %
- Air changes (per hr): ca. 15 air changes per day
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Test system
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): on average, animals were treated by instillation of 37.1 mg (range 36.8 - 37.2 mg) test material (a volume of ca. 0.1 mL), in the conjunctival sac of one of the eyes after gently pulling the lower lid away from the eyeball. The lids were then gently held together for ca. 1 second to prevent loss of the test material. The other eye remained untreated and served as the control. - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- The eys of each animal were examined 1, 24, 48 amd 72 hours after instillation of the test material.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- SCORING SYSTEM: The irritation reactions were scored using the Draize System.
TOOL USED TO ASSESS SCORE: Immediately after the 24-hour observation, a solution of 2% fluorescein in water was instilled into both eyes of each animal to quantitatively determine corneal epithelial damage.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- IRRITATION
Irritation of the cornea was noted, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 24 hours in one animal and within 48 hours in the other two animals.
No iridial irritation or corneal opacity were observed, and treatment of the eyes with 2% fluorecein, 24 hours after test material instillation revealed no corneal damage.
CORROSION
There was no evidence of ocular corrosion. - Other effects:
- COLOURATION/ REMNANTS
No staining of (peri) ocular tissues by the test material was observed. Remnants of the test material were present in the eye on Day 1.
TOXICITY/ MORTALITY
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study the test material was not found to be irritating to the eyes.
- Executive summary:
The potential of the test material to cause eye irritation was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 405, EU Method B.5, EPA OPPTS 870.2400 and JMAFF Guidelines (2000).
During the study single samples of test material (ca. 0.1 mL) were instilled into one eye of each of three rabbits. Observations were made 1, 24, 48 and 72 hours after instillation.
Instillation of the test material resulted in irritation of the conjunctivae, which consisted of redness, chemosis and discharge. The irritation had completely resolved within 24 hours in one animal and within 48 hours in the other two animals.
Remnants of the test material were present in the eye on Day 1.
Based on the results of this study, the test material is not considered to be an eye irritant.
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.
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