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Toxicological information

Eye irritation

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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.
Justification for type of information:
See attached justificétion document
Cross-reference
Reason / purpose:
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)
Justification for type of information:
See attached justification document
Reason / purpose:
read-across source
Remarks on result:
positive indication of irritation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
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

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

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.