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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other: Study available as unpublished report. Limitations in design and/or reporting but otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A HET-CAM in vitro corrosion test was performed in which three hen eggs were exposed to the test substance. Subsequently coagulation, lysis and heamorrhagia were assessed.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Name of the test substance used in the study report: 2,6-Dimethyl-4-tert.-butylbenzylcyanid

Test animals / tissue source

Species:
other: chorionallantoic membrane of fertilized hen eggs

Test system

Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
3 minutes
Observation period (in vivo):
180 seconden
Number of animals or in vitro replicates:
3 hen 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 minutes, respectively.

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

EVALUATION OF RESULTS
Usually the result of a 10% aqueous solution is used for evaluation.
mean time to coagulation < 90 seconds: risk of serious damage to the eyes
mean time to coagulation ≥ 90 seconds: no risk of serious damage to the eyes

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: time until appearance of coagulation
Basis:
mean
Time point:
other: 180 seconds
Score:
0
Max. score:
3
Irritation parameter:
other: time until appearance of haemorrhagia
Basis:
mean
Time point:
other: 180 seconds
Score:
0
Max. score:
3
Irritation parameter:
other: time until appearance of lysis
Basis:
mean
Time point:
other: 180 seconds
Score:
0
Max. score:
3

Applicant's summary and conclusion

Interpretation of results:
other: non-corrosive
Conclusions:
Under the conditions of the test the substance is considered to be of no risk of serious damage to the eyes.
Executive summary:

The potential to cause serious eye damage was determined in a HET-CAM in-vitro corrosion test (alternative method to study the potential of serious damage to the eyes/mucous membranes in incubated hen eggs). Three hen eggs were exposed to the test substance for 180 seconds. The test substance produced no coagulation, lysis or heamorrhagia effects within a relevant time period after application.