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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: ICCVAM HET-CAM
Principles of method if other than guideline:
HET-CAM in vitro corrosion test (alternative method to study the potential of serious damage to the eyes/mucous membranes in incubated hen eggs).
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Triboron trimethyl hexaoxide
EC Number:
203-016-8
EC Name:
Triboron trimethyl hexaoxide
Cas Number:
102-24-9
Molecular formula:
C3H9B3O6
IUPAC Name:
trimethoxyboroxin
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): Trimethoxyboroxin
- Physical state: liquid
- pH: ca. 5 (undiluted)
- Test substance No.: 04/0710-1
- Lot/batch No.: 559732

Test animals / tissue source

Species:
other: chorionallantoic membrane of fertilized hen eggs

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.3 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
3.5 minutes
Number of animals or in vitro replicates:
3 eggs
Details on study design:
SCORING SYSTEM:
After application of the test substance the chorionallantoic membrane was observed by means of a stereomicroscope until unambiguous irritation
reactions were detected or up to a maximum time period of 3.5 minutes, respectively.
The time of appearance (in seconds after application) of intravascular resp. extravascular coagulation and, if applicable, other reactions
(haemorrhagia, vessel lysis) were determined.

The evaluation of the reactions was performed according to the following grading:
0 = no visible change
1 = slight reaction
2 = moderate reaction
3 = severe reaction

TOOL USED TO ASSESS SCORE: stereomicroscope

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: time until appearance of coagulation
Run / experiment:
1
Value:
ca. 64
Vehicle controls validity:
not applicable
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
positive indication of irritation
Remarks:
intravascular coagulation
Irritation parameter:
other: time until appearance of coagulation
Run / experiment:
2
Value:
ca. 81
Vehicle controls validity:
not applicable
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
positive indication of irritation
Remarks:
intravascualr coagulation
Irritation parameter:
other: time until appearance of coagulation
Run / experiment:
3
Value:
ca. 49
Vehicle controls validity:
not applicable
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
positive indication of irritation
Remarks:
intravascular coagulation
Irritation parameter:
other: time until appearance of coagulation
Run / experiment:
mean n=3
Value:
ca. 64
Vehicle controls validity:
not applicable
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
positive indication of irritation
Remarks:
intravascular coagulation
Irritation parameter:
in vitro irritation score
Run / experiment:
mean
Value:
ca. 7.38
Vehicle controls validity:
not applicable
Negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
positive indication of irritation
Other effects / acceptance of results:
The formula used to generate the IS is {(301-hemorrhage time)/300}*5 + {(301-lysis time)/300}*7 + {(301-coagulation time)/300}*9

CRITERIA FOR AN ACCEPTABLE TEST
A test is considered acceptable if the negative and positive controls each induce a response
that falls within the classification of nonirritating and severely irritating, respectively.
Historical control studies indicate that using 0.9% NaCl, as a negative control, the IS value
was 0.0. Historical control studies indicate that using 1% SDS and 0.1 N NaOH, as positive
controls, the IS values ranged between 10 and 19, respectively.
9.0 DATA INTERPRETATION
When using the IS analysis method, the severe irritancy classification for a test substance is
used when the value is greater than nine.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Conclusions:
The eye irritancy potential of TMBX was examined in the HET-CAM using the ICCVAM protocol 2006. When using the IS analysis method, the severe irritancy classification for a test substance is used when the value is greater than nine. The IS obtained was 7.38, however the study director assigned Category 1 Causes Severe eye damage to the substance.