Calcium di(acetate)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1982-01-26 to 1982-02-09.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test was realized using a method equivalent to OECD 403 guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Calcium di(acetate)

EC Number:

200-540-9

EC Name:

Calcium di(acetate)

Cas Number:

62-54-4

Molecular formula:

C2H4O2.1/2Ca

IUPAC Name:

calcium diacetate

Details on test material:

- Name of test material (as cited in study report): calcium di(acetate)
- Physical state: firmly, white powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Chbb Thom (from THOMAE GmbH) Biberach/Riss
- Age at study initiation: 8 weeks
- Weight at study initiation: males: 228+/-9g and females. 195+/-20g.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2ºC
- Humidity (%): 55+/-5%
- Photoperiod (hrs dark / hrs light):12h/12h

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose/head only

Vehicle:

air

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Vibratomat - (BASF) generating air -dust mixture.
- Exposure chamber volume: 55L
- Source and rate of air: flow rates were set: 1500 L/h air through the injector and 1500 L/ h induced air as dilution air.
- Method of conditioning air: was established that the substance-air mixture in the breathing zone the animals are not diluted by laboratory air
- System of generating particulates/aerosols: to generate a dust aerosol of the test substance a dust generator ( Vibratomat)was used, which sent the dust to the inhalation device.
- Method of particle size determination: The experimental group sample was collected earlier than 30 minutes after the test, for particle size analysis. Effective cutoff aerodynamic diameter 50% was determinated.
- Temperature, humidity, pressure in air chamber: controlled


TEST ATMOSPHERE
- Brief description of analytical method used: the dust concentration was calculated from the difference between filters.
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

5.6 mg/L

No. of animals per sex per dose:

10

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days (or other?)
- Frequency of observations and weighing: 7 and 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LC50

Effect level:

> 5.6 mg/L air (analytical)

Based on:

test mat.

95% CL:

0.5

Exp. duration:

4 h

Remarks on result:

other: CL values corresponds to SD value.

Mortality:

No mortality observed.

Clinical signs:

other: No changes observed.

Body weight:

female 0 days:195
female 7 days:205
female 14 days:224
male 0 days:228
male 7 days:257
male 14 days:292

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LC50 value for 4 hours exposition at rat (male and female) is higher than 5.6 mg/L. At the dose no mortality was observed as well as any change during the pathology observations realized at the end of the study at 14 days.

Executive summary:

Calcium acetate LC₅₀value for 4 hours exposition at rat (male and female) is higher than 5.6 mg/L. At the dose no mortality was observed as well as any change during the pathology observations realized at the end of the study at 14 days.The substance is considered as nontoxic.