Registration Dossier

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:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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.