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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study (particle size not determined, but since a liquid rather than a dust aerosol was generated and in view of the high volatility of PAA, the particles can be considered as respirable.)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-3 (Acute inhalation toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Age: not indicated; Body weight: 192 – 221 g (males), 165 – 195 g (females)
Source: Harlan CPB, Zeist, The Netherlands

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: clean air
Analytical verification of test atmosphere concentrations:
yes
Remarks:
(concentration measurements during each exposure samples of test atmosphere; stability of test atmosphere determined by measuring the opacity)
Duration of exposure:
4 h
Concentrations:
0, 87, 163, 185 and 267 mg peracetic acid/m³ (actual concentration).
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
After the exposure the animals were observed for clinical symptoms and effects on body weight gain. At the end of the 14-day observation period the surviving animals were killed, evaluated for changes of their external appearance and for macroscopical changes in the cervical area and the abdominal and thoracic cavities and for changes in lung weights.

Clinical symptoms (1-4 hours after exposure, daily thereafter), body weights (at allocation to treatment groups, immediately before exposure, on days 2, 7 and 14), gross necropsy and lung weights (at termination)
Statistics:
Body weight and absolute and relative lung weights were evaluated with a one way analysis of variance and subsequently evaluated with the Students' t-test. The LC50 was calculated with logistic regression.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
204 mg/m³ air (analytical)
Exp. duration:
4 h
Remarks on result:
other: based on PAA (5% in product)
Sex:
male
Dose descriptor:
LC50
Effect level:
213 mg/m³ air (analytical)
Exp. duration:
4 h
Remarks on result:
other: based on PAA (5% in product)
Sex:
female
Dose descriptor:
LC50
Effect level:
186 mg/m³ air (analytical)
Exp. duration:
4 h
Remarks on result:
other: based on PAA (5% in product)
Sex:
male/female
Dose descriptor:
LC50
Effect level:
4 080 mg/m³ air (analytical)
Exp. duration:
4 h
Remarks on result:
other: based on product (5% PAA)
Mortality:
Mortalities were observed in the second highest (2 males, 2 females) and highest (4 males, 5 females) dose groups (see Table below). The animals died within 5 days after exposure
Clinical signs:
other: Clinical signs were observed in all treatment groups, however, less severe and frequent in the lowest dose group. These included apathy, respiratory difficulties, reduced respiratory rates, decreased fear reaction, freezing, reduced locomotor activity, tw
Body weight:
The survivors showed a temporary weight loss. Body weights had recovered at the end of the observation period.
Gross pathology:
Absolute lung weights of animals that died in the course of the study were increased when compared to the surviving animals. There were no relevant differences between treated and control animals.
Other findings:
none reported.

Any other information on results incl. tables

MORTALITY:
-----------------------------------------------------------
Exp. Level Number Dead/Number Treated
mg/m³*) Males Females Combined
-----------------------------------------------------------
not exposed 0/5 0/5 0/10
87 0/5 0/5 0/10
163 0/5 0/5 0/10
185 2/5 2/5 4/10
267 4/5 5/5 10/10
----------------------------------------------------------- *) measured concentrations of peracetic acid

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information (related to formulation containing 5% peracetic acid) Criteria used for interpretation of results: EU
Conclusions:
The LC50 for inhalation of Proxitane AHC is 4080 mg/m³ (combined) corresponding to 204 mg/m³ of peracetic acid, assuming that the test substance contains 5 % of peracetic acid.
Executive summary:

In order to investigate the toxicological effects produced by inhalative exposure to the test material Proxitane AHC, groups of 5 male and 5 female rats were exposed nose-only to measured concentrations of 0, 87, 163, 185 and 267 mg pure peracetic acid/m³ for 4 hours. After the exposure the animals were observed for clinical symptoms and effects on body weight gain. At the end of the 14-day observation period the surviving animals were killed, evaluated for changes of their external appearance and for macroscopical changes in the cervical area and the abdominal and thoracic cavities and for changes in lung weights.

Mortalities were observed in the second highest (2 males, 2 females) and highest (4 males, 5 females) dose groups. The animals died within 5 days after exposure. Macroscopical observations, including increased lung weights were indicative of pulmonary oedema. Clinical symptoms. most likely due to irritating/corrosive action of the test material in the respiratory tract, were observed in all treatment groups. The survivors showed a temporary weight loss. Body weights had recovered at the end of the observation period. No treatment related macroscopical observations and no statistically significant changes of the lung weights were observed in the survivors of all groups at the end of the observation period. In general, no distinction between the effects in males and females could be made. From the observations in this study it is concluded that the effects are caused by the corrosive action of the test material on the respiratory tract of the test animals.

The LC50 for inhalation of Proxitane AHC was 4080 mg/m³ (combined) corresponding to 204 mg/m³ of peracetic acid, assuming that the test substance contains 5 % of peracetic acid. The LC50 for males was 213 and for females 186 mg/m³ of peracetic acid, respectively.