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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
publication
Title:
Pouvoir irritant sur la peau et l'oeil du lapin de l'eau de Javel et de l'acide peracetique a differentes concentrations
Author:
Duprat P., Gradiski D., Delsaut L. and Lepage M.
Year:
1974
Bibliographic source:
Revue Med. Vet., 125(6), p.879-895

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Method: Draize Test
Exposure time 24 hours instead of 4 as recommended by OECD guideline 404.
GLP compliance:
no

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

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
water
Controls:
no
Amount / concentration applied:
- Concentration: 3.4 %, 0.34 % and 0.034 % peracetic acid
- Application volume: 0.5 mL
Duration of treatment / exposure:
24 hour(s)
Observation period:
3 days
Number of animals:
2
Details on study design:
- Test substance was diluted at 1/10, 1/100 and 1/1000 (corresponding to 3.4 %, 0.34 % and 0.034 % peracetic acid)
- Test sites were left intact or scarified
- Scoring system: according to Food and Drug Administration; Draize, Woodard and Calvery; Draize
- Examination time points: 24, 48 and 72 hours
- After 72 hours, two rabbits were sacrificed and the skin was macroscopically and microscopically examined


SCORING SYSTEM:
∑24 hours + ∑72 hours for edema and erythema. The mean values for 24 hours and 72 hours are presented in the results section.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: non-irritating
Remarks:
A 0.034% concentration was not irritating
Remarks on result:
no indication of irritation
Remarks:
0.034% peracetic acid, no individual edema score, but mean "overall irritation score" reported
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: non-irritating
Remarks:
A 0.034% concentration was not irritating
Remarks on result:
no indication of irritation
Remarks:
0.034% peracetic acid, no individual edema score, but mean "overall irritation score" reported
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: non-irritating
Remarks:
A 0.034% concentration was not irritating
Remarks on result:
no indication of irritation
Remarks:
0.034% peracetic acid, no individual erythema score, but mean "overall irritation score" reported
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: non-irritating
Remarks:
A 0.034% concentration was not irritating
Remarks on result:
no indication of irritation
Remarks:
0.034% peracetic acid, no individual erythema score, but mean "overall irritation score" reported
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24h/72h
Score:
1.6
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Remarks:
0.34% peracetic acid, no individual edema score, but mean "overall irritation score" reported
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24h/72h
Score:
1.6
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Remarks:
0.34% peracetic acid, no individual edema score, but mean "overall irritation score" reported
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24h/72h
Score:
1.6
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Remarks:
0.34% peracetic acid, no individual erythema score, but mean "overall irritation score" reported
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24h/72h
Score:
1.6
Reversibility:
fully reversible
Remarks on result:
positive indication of irritation
Remarks:
0.34% peracetic acid, no individual erythema score, but mean "overall irritation score" reported
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24h/72h
Score:
5.7
Reversibility:
not reversible
Remarks:
A 3.4% peracetic acid concentration was corrosive
Remarks on result:
positive indication of irritation
Remarks:
3.4% peracetic acid, no individual edema score, but mean "overall irritation score" reported
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24h/72h
Score:
5.7
Reversibility:
not reversible
Remarks:
A 3.4% peracetic acid concentration was corrosive
Remarks on result:
positive indication of irritation
Remarks:
3.4% peracetic acid, no individual edema score, but mean "overall irritation score" reported
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24h/72h
Score:
5.7
Reversibility:
not reversible
Remarks:
A 3.4% peracetic acid concentration was corrosive
Remarks on result:
positive indication of irritation
Remarks:
3.4% peracetic acid, no individual erythema score, but mean "overall irritation score" reported
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24h/72h
Score:
5.7
Reversibility:
not reversible
Remarks:
A 3.4% peracetic acid concentration was corrosive
Remarks on result:
positive indication of irritation
Remarks:
3.4% peracetic acid, no individual erythema score, but mean "overall irritation score" reported
Irritant / corrosive response data:
- 3.4 % test solution: corrosive
- 0.34 % test solution: slightly irritating
- 0.17 % test solution: slightly irritating
- 0.034 % test solution: not irritating, no effect other than reversible enlargement of scars in scarified skin areas
Other effects:
No other observations reported.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Remarks:
Non-irritating to corrosive, depending on the concentration topically applied to the skin of rabbits.
Conclusions:
Based on the results obtained, a 3.4 % peracetic acid solution is considered to be corrosive, while a 0.34 % dilution has slight irritating effects only; no skin irritating potential was evident with a 1/1000 dilution.
Executive summary:

The skin irritation potential of a 1/10, 1/100 and 1/1000 dilution of peracetic acid (3.4 %, 0.34 % and 0.034 %) was investigated in rabbits. Skin sites were examined macroscopically and microscopically.


 


The degree of skin reactions after dermal application of 0.5 mL of peracetic acid was concentration dependent. Eschar formation, necrosis and moderate edema was seen with the 1/10 dilution (3.4 % peracetic acid), while slight erythema and edema formation was evident with the 1/100 dilution (0.34 % peracetic acid); following topical application of a 1/1000 dilution (0.034 % peracetic acid), no skin reactions were evident. Microscopically, with the 1/10 dilution, necrosis of the dermis and epidermis was evident while with the 1/100 dilution, microscopic findings were not as pronounced as observed with the 1/10 dilution. Only slight local effects were notable with the 1/1000 dilution. Complete reversibility was observable only for the highest dilution, while scar formation was noted with the 1/10 dilution on days 23-25 of the study and on day 13 with the 1/100 dilution.

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