Registration Dossier

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:
1982
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

Constituent 1
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

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