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Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980-09-12 - 1980-12-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Only male rats were used in this investigation. This is not considered to have comprised the study results as in a comparable investigation performed with Virkon S dust in male and female rats of the same strain and source, male rats were demonstrated to be slightly more sensitive than female rats (please refer to the Endpoint summary record Sect. 7.2.2; Doc. No. 528-002). Thus, the inhalation study reliably reflects and does not underestimate the acute inhalation toxicity potential of KMPS triple salt dust.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
EPA OPP 81-3 (Acute inhalation toxicity)
Deviations:
no
Principles of method if other than guideline:
The 4-hour LC50 of KMPS triple salt dust was determined in male rats. Groups of 10 male rats were exposed to atmospheres of KMPS triple salt dust for single 4-hour periods. The concentrations ranged from 1.5 to 5.0 mg/L, higher atmospheric concentrations could not be generated under the given experimental conditions.
GLP compliance:
no
Remarks:
, GLP was not compulsory at the time of study conduct. In addition, laboratories in the USA are not certified by any governmental agency, but are subject to official inspections.
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Pentapotassium bis(peroxymonosulphate) bis(sulphate)
EC Number:
274-778-7
EC Name:
Pentapotassium bis(peroxymonosulphate) bis(sulphate)
Cas Number:
70693-62-8
Molecular formula:
H3K5O18S4
IUPAC Name:
pentapotassium bis((hydroperoxysulfonyl)oxidanide) hydrogen sulfate sulfate
Test material form:
solid

Test animals

Species:
rat
Strain:
other: Crl:CD
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Not indicated; rats used at Haskell laboratories were acquired from Charles River Laboratories Inc., Raleigh, North Carolina; U.S.A
- Age at study initiation: 8 weeks
- Weight at study initiation: 228 – 298 g

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
head only
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
A dust aerosol of Oxone® (Potassium Peroxymonosulfate/KMPS triple salt) was generated with a 3-stage glass generator composed of dust reservoir, cyclone generator, and elutriator. A stirring rod with plastic paddles agitated the dust in the first 2 stages. Air introduced at the reservoir carried dust particles up to the generator and elutriator. Additional houseline air swept airborne dust from the elutriator stage into the chamber


VEHICLE
- Composition of vehicle: dilution with clean air (“houseline air”) only


TEST ATMOSPHERE
- Particle size distribution: The mass median aerodynamic diameter (MMAD) of the dust generated ranged from 1.7 to 4.0 µm (please refer to table 1, presented under "Any other information on materials and methods incl. tables").
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
1.5, 3.9, 4.2, 5.0 mg/L (higher atmospheric concentrations could not be generated under the conditions used in the study)
Please refer to table 1, presented under “Any other information on materials and methods incl. tables”.
No. of animals per sex per dose:
10 animals (males) per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days post-observation

-Examinations performed:
* Rats were quarantined in pairs, in stainless-steel wire mesh cages for 1 week prior to use. During this period, rats were weighed and observed for normal weight gain and overt manifestations of disease. Food and water were provided ad libitum.
* During exposure, all rats were observed and clinical signs noted.
* Following exposure, rats were weighed and observed daily (excluding weekends) for a 14-day observation period.
Statistics:
In the absence of any deaths occurring at any exposure levels, a statistical method was not required for the determination of acute inhalation LC50.

Results and discussion

Preliminary study:
not indicated
Effect levels
Key result
Sex:
male
Dose descriptor:
LC50
Effect level:
> 5 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: no deaths occured
Mortality:
No deaths were reported at any exposure level during exposure and during the 14-day observation period.
Please refer to the table presented under “Remarks on results including tables and figures”.
Clinical signs:
other: During exposure: In all exposures animals exhibited reduced response to sound and moderate to severe, ocular and nasal discharge increasing with concentration. Rats exposed at 1.5 mg/L exhibited moderate lung nouse immediately post exposure. This was not
Body weight:
not indicated
Gross pathology:
No pathological findings reported.
Other findings:
One rat at the highest exposure level of 5.0 mg/L was injured upon removal from the wire mesh restrainer. It was subsequently sacrificed.

Any other information on results incl. tables

 


Mortality




































-



Mean Atmospheric Concentration
(mg/L)



Mortality
(No. deaths /No. exposed)



Time of death
(day of death/no. of animals)



Male rats



1.5



0/10



-



-



3.9



0/10



-



-



4.2



0/10



-



-



5.0



0/9*



-



*:           One rat was injured upon removal from the wire mesh restrainer. It was subsequently sacrificed

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). When male Crl:CD rats were exposed head-only for a single 4-hour exposure period towards Oxone® (KMPS triple salt) dust at particle sizes lying well within the respirable range for rats, no deaths occurred up to and including the highest exposure level of 5.0 mg/L tested. Thus, Oxone (KMPS triple salt) does not have to be classified and labelled with respect to acute inhalation toxicity.
Executive summary:

Materials and methods


The purpose of this investigation was to determine the 4-hour LC50 of Oxone ® (KMPS triple salt) dust in male Crl:CD rats.


Groups of 10 male Crl:CD rats were exposed head-only for a single 4-hour period to dust atmospheres of KMPS triple salt at concentrations of 1.5, 3.9, 4.2 and 5.0 mg/L. Higher atmospheric concentrations could not be generated under these conditions. Except during exposure, rats were housed in pairs, in stainless-steel wire mesh cages. Food and water was provided ad libitum. Rats were quarantined under these conditions for 1 week prior to use. During this period, rats were weighed and observed for normal weight gain and overt manifestations of disease. During exposure, all rats were observed and clinical signs noted. Following exposure, rats were weighed and observed daily (excluding weekends) for a 14-day observation period.


Dust atmospheres were generated with a 3-stage glass generator. Chamber concentrations were gravimetrically verified at 30 min intervals. Particle size measurements were performed once during each exposure.


 


Results and discussion


A single 4-hour head-only exposure of male rats to chamber concentrations of 1.5, 3.9, 4.2 and 5.0 mg/L caused no mortalities during exposure and the following 14-day post-observation period. During exposure, clinical signs were characterised by moderate to severe ocular and nasal discharge increasing with concentration. Lung noise was reported for the low exposure level only. Slight to severe weight loss during days 1 through 4 and alopecia around the eyes, cloudy eyes as well as severe discharge from eyes and nose was evident at the three highest exposure levels. Weight gain returned to normal during the remainder of the observation period at these exposure levels.


An LC50 could not be determined since no deaths occurred at any exposure concentration.


The MMAD of the dust was determined to be 1.7 to 4.0 µm. Thus, the MMAD was well within the respirable range for rats at all exposure levels.