Bis(pentane-2,4-dionato)calcium

Acute Toxicity: inhalation

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

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(pentane-2,4-dionato)calcium

EC Number:

243-001-3

EC Name:

Bis(pentane-2,4-dionato)calcium

Cas Number:

19372-44-2

Molecular formula:

C10H14CaO4

IUPAC Name:

calcium bis[(2Z)-4-oxopent-2-en-2-olate]

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 or test system 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