Registration Dossier
Registration Dossier
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EC number: 213-103-2 | CAS number: 924-42-5
Acute Toxicity: inhalation
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:
- 1 975
- 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
- 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
Constituent 1
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.
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