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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
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 433 draft (Acute Inhalation Toxicity: Fixed Concentration Procedure) (not officially approved)
Deviations:
not specified
GLP compliance:
no
Remarks:
Pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Acrylamide
EC Number:
201-173-7
EC Name:
Acrylamide
Cas Number:
79-06-1
Molecular formula:
C3H5NO
IUPAC Name:
prop-2-enamide
Details on test material:
- Name of test material (as cited in study report): 50% acrylamide
- Substance type: organic
- Physical state: liquid (aqueous solution)
- Analytical purity: not specified
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: 49±2% w/w in solution
- Isomers composition: not applicable
- Purity test date: 07/05/1975
- Lot/batch No.: MM04115-7
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: not specified
- Age at study initiation: not specified
- Weight at study initiation: 265-279 g
- Fasting period before study: not specified
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature
- Humidity (%): not specified

IN-LIFE DATES: 15/05/1975 to 29/05/1975

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass chamber
- Exposure chamber volume: 160 litres
- Method of holding animals in test chamber: restricted chamber volume
- Source and rate of air: 50 litres/minute by positive pressure spray nozzle
- Method of conditioning air: not specified
- System of generating particulates/aerosols: not specified
- Method of particle size determination: Royco particle analyser/light scattering
- Treatment of exhaust air: not specified
- Temperature, humidity, pressure in air chamber: not specified

TEST ATMOSPHERE
- Brief description of analytical method used: nominal
- Samples taken from breathing zone: no

VEHICLE: Substance was tesed as an aqueous solution

TEST ATMOSPHERE
- Particle size distribution: 1.95 microns (mean value) with 99% of particles 6 microns or smaller
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.95
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
1 h
Concentrations:
12 mg of test substance/litre
No. of animals per sex per dose:
6 males !one dose)
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 15/5, 16/5, 19/5, 21/5, 23/5, 28/5, 29/5
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight
Statistics:
None

Results and discussion

Preliminary study:
None
Effect levels
Sex:
male
Dose descriptor:
LC0
Effect level:
12.1 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
1 h
Mortality:
One animal died as a result of an infection unrelated to chemical exposure.
Clinical signs:
other: No visible lesions could be attributed ot the test material.
Body weight:
No effects could be attributed ot the test material.
Gross pathology:
Not performed.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results of this test indicate that the 50.7% solution of acrylamide is practically non-toxic by the inhalation route with a LC0 of 12 g/m3.