Registration Dossier

Toxicological information

Repeated dose toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Reporting deficiencies including the nature, concentration and the stability of the test substance. No analytical determination of atmospheric concentrations of peracetic acid was made. Furthermore, the study was not carried out in accordance with international GLP or study guidelines. The daily exposure (45 minutes) was short compared to standard guidelines and only one concentration was tested. No clinical chemistry was performed and extent of haematology investigations was limited.

Data source

Reference
Reference Type:
publication
Title:
Tolerability of Peracetic Acid Aerosols to Animals with Particular Reference to Impairment of Organic Defence (in German with English abstract)
Author:
Heinze, W. et al
Year:
1979
Bibliographic source:
Mh. Vet.-Med. 34, 212-217

Materials and methods

Principles of method if other than guideline:
The study aimed at testing any adverse impact on immunisation when mice exposed to peracetic acid aerosol were subsequently infected with a highly virulent tester germ strain.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Age and weight not indicated

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: water
Details on inhalation exposure:
For the preparation of aerosol particles/droplets, and ultrasonic aerosol device TUR USI 4 was used.
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
45 min per day for a period of 14 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
30 mg peracetic acid/20 L air = 1.5 g peracetic acid/m³ (1.2 mL 6.25 % Wofasteril/20 L)
Basis:
nominal conc.
No. of animals per sex per dose:
50
Control animals:
yes, concurrent vehicle
Details on study design:
2 groups of mice were immunised with the “Red Murrain Vaccine Dessau” by subcutaneous injection of 1 million germs into the sacral region. One of the immunised groups was exposed to peracetic acid, the other group remained untreated. Both immunised groups as well as a non-immunised control group (group 3) were treated with red murrain germs at the end of the study. Group 4 served as peractic acid treated control only.

Examinations

Observations and examinations performed and frequency:
- Clinical signs and mortality: not indicated

- Body weight: not indicated

- Haematology: not performed


Sacrifice and pathology:
A pathological examination was performed; histopathology was conducted in particular on kidneys, liver and lungs.
Statistics:
Yes, method not mentioned.

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Details on results:
Mortality: No deaths were reported.

Gross and histopathology: no pathological/histopathological findings reported

Other examinations: In mice which have been subcutaneously treated and immunised with “Red Murrain Vaccine Dessau” and subsequently infected with the highly virulent tester germ strain “Frankfurt XI” it was demonstrated that exposure towards peracetic acid for a period of 14 days does not have an adverse impact on immunisation of mice. In contrast to immunised and peracetic acid exposed mice as well as immunised and not peracetic acid exposed mice, all mice which were not immunised but infected with the tester germs, died within 24 hours after infection. No effects were reported on mice which were not immunised and not infected but exposed to a peracetic acid aerosol for a period of 14 days only.

Effect levels

Dose descriptor:
NOAEL
Effect level:
1 500 mg/m³ air (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: based on PAA (impairment of the immune defence)

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
In mice which were immunised against red murrain germs followed by inhalation exposure towards peracetic acid for 14 days and subsequent infection with red murrain germs, no impairment of the immune defence could be observed when comparison to immunised and infected mice was made.
Executive summary:

When groups of mice which have been subcutaneously treated and immunised with “Red Murrain Vaccine Dessau” were exposed to an aerosol of peracetic acid at a concentration of 1.5 g/m3 for a period of 14 days and subsequently infected with the highly virulent tester germ strain “Frankfurt XI”, no adverse impact on immunisation of mice was observable. In contrast to immunised and peracetic acid exposed mice, all mice which were not immunised but infected with the tester germs, died within 24 hours after infection. No treatment- or exposure-related effects were reported on mice which were not immunised and not infected but exposed to a peracetic acid aerosol for a period of 14 days only.