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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted and documented study, fully adequate for assessment. Performed guideline conform and according to GLP in a recognised contract research organisation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Bis(pentan-2,4-dionato)calcium
- Substance type: industrial chemical
- Physical state: powder
- Analytical purity: ca. 99.6%
- Impurities (identity and concentrations): water ca. 0.4%
- Lot/batch No.: 140704-1, 140704-2, 140704-3
- Expiration date of the lot/batch: June 2017
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Toxi-Coop Zrt., 1103 Budapest, Hungary
- Age at study initiation: 9 - 10 weeks
- Fasting period before study: not reported
- Diet : ad libitum
- Water (tap water) : ad libitum
- Acclimation period: 6 days to lab conditions plus 7 - 9 days to the test apparatus


ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C
- Humidity: 30 - 70%
- Room air change: 10 - 15 times per hour
- Light/dark cycle: 12/12 h

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
The animals were exposed to an atmosphere of the test item generated according to the system and flow rates determined during the technical trials, for a single, four-hour period. The four-hour exposure period was not started until theoretical chamber concentration equilibration of 0.5 minutes, calculated according to Silver S. D. (1946) has been reached. Based on the experience gained in the trial runs 5 minutes were let for equilibration. The periods when exposures were interrupted to re-fill the dust generator and for cleaning of the exposure system from deposited test item were also not taken into account as part of the four-hour exposure. In order to achieve the required concentration during exposure the test item input rate was adjusted according to the actual concentration level indicated by the monitoring system.
Analytical verification of test atmosphere concentrations:
yes
Remarks:
Aerosol Light Scattering Photometer calibrated by gravimetry of samples obtained on aerosol filters
Duration of exposure:
4 h
Concentrations:
5470 mg/m³
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for morbidity/mortality twice daily; body weights on days 0, 1, 3, 7, and 14
- Necropsy of survivors performed: yes, complete examination of abdominal and thoracic cavities
- Other examinations performed: clinical signs : behaviour, mucous membranes, respiratory system
Statistics:
not reported

Results and discussion

Preliminary study:
In a pre-test with each one male and one female rat a 4 hour exposure at 4.33 mg/l air did not cause mortality or severe clinical signs. Accordingly, a limit test was performed.
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.47 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Mortality:
no mortality
Clinical signs:
other: directly after exposure animals showed slight dyspnea. One day after exposure until the end of the observation period there were no clinical signs observed.
Body weight:
In all male and female animals body weight loss was observed on day 1 after exposure. Body weight recovered in the following days and after 14 days all animals had higher body weights than prior to treatment.
Gross pathology:
no findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU