Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EPA Toxic Substances Health Effects Test Guidelines (PB82-232984), Primary Eye Irritation
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Peracetic acid
EC Number:
201-186-8
EC Name:
Peracetic acid
Cas Number:
79-21-0
Molecular formula:
C2H4O3
IUPAC Name:
Peracetic acid generated by perhydrolysis of N-acetylcaprolactam by hydrogen peroxide in alkaline conditions

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: H.A.R.E., Hewitt, NJ, USA
- Sex: males and females
- Age: Young adult
- Weight: 2.28 – 2.36 kg (males), 2.05 – 2.53 kg (females)
- Number of animals per group: 3
- Controls: The left eyes served as controls

Test system

Vehicle:
other: the test material was dosed as received
Controls:
no
Amount / concentration applied:
- Concentration: 17 %
peracetic acid
- Application volume: 0.1 mL
Duration of treatment / exposure:
For 3 animals: Not applicable, eyes remained unwashed
For 3 animals: 20-30 seconds, eyes were washed thereafter with water.
Observation period (in vivo):
22 days
Number of animals or in vitro replicates:
6
Details on study design:
- Method of Administration: a volume of 0.1 mL test material was administered per test eye. The eyes of three of the rabbits were left unwashed while the eyes of the remaining three rabbits were gently washed with 100 mL of tap water 1 20-30 seconds after treatment
- Ophtalmoscopic examination: changes of the cornea, iris and conjunctiva
- Scoring system: Method of Draize - Observation period: observations were made at 1, 24, 48 and 72 hours and on day 4, 7, 10, 13 and 16 of the study

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 16 days
Remarks on result:
positive indication of irritation
Remarks:
Eye unwashed
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.66
Max. score:
4
Reversibility:
not fully reversible within: 16 days
Remarks on result:
positive indication of irritation
Remarks:
Eye unwashed
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 16 days
Remarks on result:
positive indication of irritation
Remarks:
Eye unwashed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of mild irritation
Remarks:
Eye unwashed
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.66
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
probability of weak irritation
Remarks:
Eye unwashed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
Eye unwashed
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 16 days
Remarks on result:
positive indication of irritation
Remarks:
Eye unwashed
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 16 days
Remarks on result:
positive indication of irritation
Remarks:
Eye unwashed
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 16 days
Remarks on result:
positive indication of irritation
Remarks:
Eye unwashed
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 16 days
Remarks on result:
positive indication of irritation
Remarks:
Eye unwashed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 16 days
Remarks on result:
positive indication of irritation
Remarks:
Eye unwashed
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.66
Max. score:
4
Reversibility:
not fully reversible within: 16 days
Remarks on result:
positive indication of irritation
Remarks:
Eye unwashed
Irritant / corrosive response data:
Twenty-four hours after dosing, all eyes had dense corneal opacities, white conjunctivas, iritis and conjunctivitis. Washing the test eyes with tap water shortly after exposure did not significantly decrease the irritation observed.
The signs of irritation continued throughout the study as well as necrosis of the eyelids in all animals and a corneal eruption in one rabbit.
Other effects:
Diarrhoea (1 animal, day 7, died on day 8)

Any other information on results incl. tables

AVERAGE SCORE


Table 1: Individual scores 24 hours after end of treatment












































































Animal number



Cornea Opacity/Area



Iris Score



Conjunctiva



Other comments



 



 



 



Redness



Chemosis



Discharge



 



1 M



4/4



2



0



1



2



Cw



2 M



3/4



2



0



1



3



Cw



3 M



3/4



2



0



2



2



Cw



4 F (w)



2/4



2



0



1



3



Cw



5 F (w)



3/4



2



0



2



3



Cw



6 F (w)



2/4



2



0



2



3



Cw



M= male


F= female


(w)= washed


Cw= conjunctiva - white


 


Table 2: Individual scores 48 hours after end of treatment












































































Animal number



Cornea Opacity/Area



Iris Score



Conjunctiva



Other comments



 



 



 



Redness



Chemosis



Discharge



 



1 M



3/4



2



0



3



2



Cw



2 M



4/4



2



2



4



3



Cw



3 M



4/4



2



2



4



3



Cw



4 F (w)



3/4



2



0



4



3



Cw



5 F (w)



3/4



2



2



3



3



Cw



6 F (w)



4/4



2



1



4



3



Cw



M= male


F= female


(w)= washed


Cw= conjunctiva - white


 


Table 3: Individual scores 72 hours after end of treatment












































































Animal number



Cornea Opacity/Area



Iris Score



Conjunctiva



Other comments



 



 



 



Redness



Chemosis



Discharge



 



1 M



4/4



2



0



3



2



Cw



2 M



4/4



2



0



4



3



Cw



3 M



4/4



2



0



4



3



Cw



4 F (w)



4/4



2



0



4



3



Cw



5 F (w)



4/4



2



0



4



3



Cw



6 F (w)



4/4



2



0



4



3



Cw



M= male


F= female


(w)= washed


Cw= conjunctiva - white

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of this study, the test material is judged to be extremely irritating to both unwashed and washed eyes. In the light of the necrosis noted, the test material is considered to be corrosive to the eye.
Classification: risk of serious damage to eyes
Executive summary:

Dilute peracetic acid was instilled into the test eyes of six rabbits at a dose of 0.1 mL. The eyes of three of the rabbits were not washed while the eyes of the remaining three rabbits were gently washed with 100 mL of tap water approximately 20-30 seconds after treatment. Eyes were assessed for irritation using the method of Draize at 1, 24, 48 and 72 hours as well as day 4, 7, 10, 13 and 16 of the study. The study was terminated on day 22.


 


24 hours after dosing, all eyes had dense corneal opacities, white conjunctivas, irititis and conjunctivitis. These signs of irritation continued to be observed throughout the study as well as necrosis of the eyelids in all animals and a corneal eruption in one rabbit. By day 19 of the study, the eyes could no longer be scored due to fusion of the eyelids. The test was terminated on day 22 of the study. Washing the eyes shortly after application did not significantly reduce the irritating effect.

Categories Display