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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: The Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3,5-tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
EC Number:
257-913-4
EC Name:
1,3,5-tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
Cas Number:
52434-90-9
Molecular formula:
C12H15Br6N3O3
IUPAC Name:
tris(2,3-dibromopropyl)-1,3,5-triazinane-2,4,6-trione
impurity 1
Reference substance name:
unknown impurities
IUPAC Name:
unknown impurities
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Sample code n°: 507-43

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino rabbit

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
79 mg
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 1 day
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.72
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
The numerical scores awarded to the ocular reactions elicited by test sample 507-43 are given in section "Any other information on results incl. tables".
None of the animals gave a positive reaction. Mild conjunctival reactions (redness) were observed in all six animals.

Any other information on results incl. tables

The numerical scores awarded to the ocular reactions elicited by Sample 507-43 are presented in Table 1 below:  


 























































































































































































































































Table 1

Animal No.



Region of eye



Day



Positive (+) or Negative (-) Result



1



2



3



4



7



14



1



Cornea



0



0



0



0



0



0



-



Iris



0



0



0



0



0



0



Conjunctivae redness



0



1



1



1



1



0



Conjunctivae chemosis



0



0



0



0



0



0



2



Cornea



0



0



0



0



0



0



-



Iris



0



0



0



0



0



0



Conjunctivae redness



1



1



1



1



1



0



Conjunctivae chemosis



1



0



0



0



0



0



3



Cornea



0



0



0



0



0



0



-



Iris



0



0



0



0



0



0



Conjunctivae redness



1



1



1



0



0



0



Conjunctivae chemosis



0



0



0



0



0



0



4



Cornea



0



0



0



0



0



0



-



Iris



0



0



0



0



0



0



Conjunctivae redness



1



1



1



0



0



0



Conjunctivae chemosis



0



0



0



0



0



0



5



Cornea



0



0



0



0



0



0



-



Iris



0



0



0



0



0



0



Conjunctivae redness



1



0



0



0



0



0



Conjunctivae chemosis



0



0



0



0



0



0



6



Cornea



0



0



0



0



0



0



-



Iris



0



0



0



0



0



0



Conjunctivae redness



1



0



0



0



0



0



Conjunctivae chemosis



0



0



0



0



0



0



 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Sample 507-43 gave a negative result for eye irritation, according to the definition given in the Code of Federal Regulations of the U.S.A.
Executive summary:

The procedure employed was that prescribed by The Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.42, a transcript of which is attached as an Appendix to the full study report.


For the test, 79 mg of sample 507-43 was instilled into one eye of each six animals, while the untreated eye was used as concurrent control. 


The numerical scores awarded to the ocular reactions elicited by 507-43 are given in Table 1: none of the animals gave a positive reaction and only mild conjunctival reactions were observed in all six animals.


Sample 507-43 gave a negative test for eye irritation, according to the definition given in the Code of Federal Regulations of the U.S.A.