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EC number: 201-186-8 | CAS number: 79-21-0
Eye irritation
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:
- 1 983
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
- 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
Constituent 1
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.
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