Registration Dossier
Registration Dossier
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EC number: 272-729-4 | CAS number: 68910-05-4 A complex residuum from the fractionation of the reaction products of 2-aminoethanol with ammonia to remove piperazine. It may contain such compounds as 2-[(2-aminoethyl)amino]ethanol, (aminoethyl)piperazine, (hydroxyethyl)piperazine.
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16.11.82 - 15.06.83
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented study report, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 10 rats per sex were exposed to aerosols containing various concentrations of the test substance.
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- Ethanol, 2-amino-, reaction products with ammonia, by-products from
- EC Number:
- 272-729-4
- EC Name:
- Ethanol, 2-amino-, reaction products with ammonia, by-products from
- Cas Number:
- 68910-05-4
- Molecular formula:
- Unspecified
- IUPAC Name:
- Ethanol, 2-amino-, reaction products with ammonia, by-products from
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): DEA, by-products
- no further data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. Thomae GmbH, Biberach, Germany
- Age at study initiation: 12 weeks
- Mean weight at study initiation: 281 g (males), 190 g (females)
- Fasting period before study: none
- Housing: groups of 5
- Diet: Ssniff laboratory diet or Kliba laboratory diet ad libitum
- Water: Tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure chamber volume: 55
- Method of holding animals in test chamber: restrained
- Source and rate of air:
- Method of conditioning air:
- System of generating particulates/aerosols:
- Method of particle size determination:
- Treatment of exhaust air:
- Temperature, humidity, pressure in air chamber: 19-25°C, 1.45-1.65 bar
TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography
- Samples taken from breathing zone: yes - Duration of exposure:
- 4 h
- Concentrations:
- 0.62, 1.14, 1.39, 1.69 mg/l
- No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 21 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight (day 0, 7, 14)
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.62 - < 1.14 mg/L air
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.48 - < 4.56 mg/L air
- Exp. duration:
- 1 h
- Mortality:
- 0.62 mg/l dosing group: 0/20
1.14 mg/l dosing group: 8/10 males, 9/10 females (day 2-day 21)
1.39 mg/l dosing group: 5/10 males, 3/10 females (day 2-day 21)
1.69 mg/l dosing group: 10/10 males, 6/10 females (day 2-day 14) - Clinical signs:
- other: during exposure: closed eyes, fitful breathing, bloody secretion (nose); after exposure: elevated fitful respiration, respiratory sounds, labored respiration, bloody secretion, squatting posture, scrubby coat,
- Body weight:
- male animals: reduced body weight gain 7 days following treatment which turned to normal till day 21.
female animals: reduced body weight gain 7 days following treatment which turned to normal till day 21 only in 1 animal (group 3, 1.14 mg/l) - Gross pathology:
- deceased animals: congestive hyperemia, lung: filled with blood, hydrostatic oedema, liver: grey-colored, maculation of liver lobes
survivors: chronic pneumonia
Any other information on results incl. tables
MMAD 50: 1.0 µm
Applicant's summary and conclusion
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