Registration Dossier
Registration Dossier
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EC number: 436-230-7 | CAS number: 359406-89-6
Eye irritation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read-across from supporting substance. Acceptable scientific method, not conducted to GLP.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Reason / purpose for cross-reference:
- read-across source
- Remarks on result:
- positive indication of irritation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- In vitro Isolated Eye (Modification of Burton et al (1981), Fd Cosmet. Toxicol, 19:471-480)
- GLP compliance:
- no
Test material
Constituent 1
Test animals / tissue source
- Species:
- other: Isolated rabbit eye
Test system
- Duration of treatment / exposure:
- 10 seconds
- Observation period (in vivo):
- 5 hours
- Number of animals or in vitro replicates:
- 2 isolated eyes
Results and discussion
In vitro
Results
- Remarks on result:
- other: see table "results of in vivo study"
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: corneal swelling
- Basis:
- mean
- Time point:
- other: 0.5 hours
- Score:
- 5.4
- Remarks on result:
- other: S.D. 1.9
- Irritation parameter:
- other: corneal swelling
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- 7.4
- Remarks on result:
- other: S.D. 0.9
- Irritation parameter:
- other: corneal swelling
- Basis:
- mean
- Time point:
- other: 2 hours
- Score:
- 13
- Remarks on result:
- other: S.D. 4.2
- Irritation parameter:
- other: corneal swelling
- Basis:
- mean
- Time point:
- other: 3 hours
- Score:
- 22
- Remarks on result:
- other: S.D. 2.8
- Irritation parameter:
- other: corneal swelling
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 24
- Remarks on result:
- other: S.D. 5.7
- Irritation parameter:
- other: corneal swelling
- Basis:
- mean
- Time point:
- other: 5 hours
- Score:
- 29.4
- Remarks on result:
- other: S.D. 3.7
Any other information on results incl. tables
ITC 826 Concentrate caused significant corneal swelling following a 10 second exposure. A maximal swelling of 29.4% was observed at 5 hours post dosing. Minimal opacity was seen in both eyes at 2, 3, 4 and 5 hours post dosing.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- ITC826 Concentrate was considered likely to be a severe ocular irritant in vivo.
- Executive summary:
ITC 826 Concentrate was assessed for corrosive properties to the eye using the rabbit isolated eye assay. Two rabbit eyeballs were dissected and rinsed with saline then mounted vertically in a Perspex clamp. The clamp was positioned in a chamber where temperature was maintained at 32ºC. A saline drip was positioned so that drops of saline fell onto the upper margin of the cornea and irrigated the whole corneal surface. A pre-treatment measurement was made of corneal thickness. The eyes were left to equilibrate for 45-60 minutes after which a second measurement of corneal thickness was taken.
The eyes were removed from the chamber and placed into Petri dishes containing saline for dosing of 0.1 ml of the test substance. The test substance was left in contact with the cornea for 10 seconds, then the eyes were rinsed with saline before being returned to the chamber.
Measurements of corneal thickness and opacity were recorded at 0 (pre-dose), 1, 2, 3, 4 and 5 hours post dosing. 2% fluorescein sodium was applied to the cornea at 5 hours post dosing for 10 seconds, then the eyes were rinsed. The presence of any stained cells was recorded. Mean % corneal swelling and standard deviation from the mean were measured. Materials causing the eyes to swell more than 15% are considered to have potential to be severe eye irritants in vivo.
ITC 826 Concentrate caused significant corneal swelling following a 10 second exposure. A maximal swelling of 29.4% was observed at 5 hours post dosing. Minimal opacity was seen in both eyes at 2, 3, 4 and 5 hours post dosing.
ITC826 Concentrate was considered likely to be a severe ocular irritant in vivo.
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