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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:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
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:
None
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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24-72 h
Reversibility:
not fully reversible within:
Remarks on result:
other: 3.4% peracetic acid - corrosive
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 - 72 h
Reversibility:
other: non-irritating
Remarks on result:
other: 0.034% peracetic acid
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 - 72 h
Reversibility:
fully reversible
Remarks:
slightly irritating
Remarks on result:
other: 0.34% peracetic acid
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:
other: 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.