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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Justification for type of information:
For details on endpoint-specific justification, please see read-across justification document (category approach) in the linked category of dimethylalkylamines.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Decyldimethylamine
EC Number:
214-302-7
EC Name:
Decyldimethylamine
Cas Number:
1120-24-7
Molecular formula:
C12H27N
IUPAC Name:
decyldimethylamine

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
not fully reversible within: 22 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 22 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
1.23
Max. score:
4
Reversibility:
not fully reversible within: 22 days

Any other information on results incl. tables

 


Results presented above were obtained with the source substance C16-DMA.


 


Additional results for C16-DMA:


 


Mean valuea for occulat lesions 24, 48 and 72 h after instillation

































Animal number and sexCorneal opacityIridial lesionsRedness of ConjunctivaChemosis
27TK490F0112
27TK533F0110,7
27TK534F0011

 


Grades for occular irritation responses






















































































































































Animal No. and Sex: 27TK490F#



Pain evaluation response: 0



 



 



 



Region of
the eye



Response



 



Grade of response at time alter instillation


Hours              Days                        



 



1



24



48



72



8



15



22



Comea



Opacity



0



0



0



0



0



0



0



 



Area



0



0



0



0



0



0



0



 



Ulceration



 



 



 



 



 



 



 



 



Stippling



 



 



 



 



 



 



 



Iris



Value



1



1



1



1



0



0



1



Conjunctiva



Redness



2



1



1



1



*



*



1



 



Chemosis



0



2



2



2A



OA



OA



0



 



Discharge



2



1



1



2



*



*



1



 



Necrosis



-



 



 



 



 



 



 



 



Ulceration



-



-



 



 



 



 



 


        BC BC

 


Grades for occular irritation responses






















































































































































Animal No. and Sex: 27TK534F



Pain evaluation response: 0



 



 



 



Region of
the eye



Response



 



Grade of response at time alter instillation


Hours           Days



 



1



24



48



72



8



15



22



Cornea



Opacity



0



0



0



0



0



0



0



 



Area



0



0



0



0



0



0



0



 



Ulceration



 



 



 



 



 



 



 



 



Stippling



 



 



 



 



 



 



-



Iris



Value



1



0



0



0



0



0



0



Conjunctiva



Redness



1



1



1



1



1



1



1



 



Chemosis



I



2A



IA



OA



OA



OA



0



 



Discharge



1



1



0



0



1



0



0



 



Necrosis



 



 



 



 



 



 



 



 



Ulceration



 



 



 



 



 



 



 


        BC BC

 



#Sentinel animal



* Impossible to open eye sufficiently to assess


A Blepharitis


B Peri-orbital exfoliation


C Peri-orbital hair loss

Applicant's summary and conclusion

Executive summary:

The study used as source investigated eye irritation/corrosion of C16-DMA. The study results of the source compound were considered applicable to the target compound. Justification and applicability of the read-across approach (category approach) is outlined in the read-across report in the linked category of dimethylalkylamines.