Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study available as unpublished report, no restrictions, contributing to a weight of evidence assessment

Data source

Reference
Reference Type:
other: summary report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Principles of method if other than guideline:
HET-CAM in vitro corrosion test was performed in which two hen eggs were exposed to the undiluted substance and three egges to 10% water solution.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ethylendiamin-Monotosylat

Test animals / tissue source

Species:
other: chorionallantoic membrane of fertilized hen eggs

Test system

Vehicle:
water
Amount / concentration applied:
Undiluted and 10% doubly distilled water
Duration of treatment / exposure:
single application
Observation period (in vivo):
210 seconds
Number of animals or in vitro replicates:
2 eggs to undiluted substance
3 eggs to 10% concentration
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 coagulation and haemorrhagia 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

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: 40 seconds
Score:
2
Max. score:
3
Remarks on result:
other: undiluted test substance
Irritation parameter:
other: time until appearance of haemorrhagia
Basis:
mean
Time point:
other: 17 seconds
Score:
1
Max. score:
3
Remarks on result:
other: undiluted test substance
Irritant / corrosive response data:
No changes were observed with the 10% aqueous dilution relevant for evaluation.

Applicant's summary and conclusion

Interpretation of results:
other: does not produced serious eye damage
Conclusions:
Under the conditions of the test the substance is considered to be of no rlsk of serious damage to the eyes.
Executive summary:

The potential to cause serious eye damage was determined in the 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 undiluted test substance or 10% water solution for 210 seconds. The undiluted test substance produced moderate coagulation effects within a relevant time period after application, but no changes were observed with the 10% aqueous dilution relevant for evaluation.