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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to standart guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
2-methylbut-3-en-2-ol
EC Number:
204-068-4
EC Name:
2-methylbut-3-en-2-ol
Cas Number:
115-18-4
Molecular formula:
C5H10O
IUPAC Name:
2-methylbut-3-en-2-ol
Details on test material:
- Name of test material (as cited in study report): 2-methylbut-3-en-2-ol
- Product No.: 01256
- Purity: > 99 %
- Physical state: liquid/colourless
- Storage conditions: room temperature
- Stability: was ensured for at least the study period .

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr . K . Thomae GmbH, Biberach, D
- Age at study initiation: approx . 8 - 9 weeks
- Weight at study initiation: 256 +/- 6.8 g (males), 193 +/- 6.3 g (females)
- Identification: by color marking on the tail
- Housing: in groups of five in cages type D III of Becker, without bedding
- Diet: KLIBA rat/mouse laboratory diet 24-343-4 10 mm pellets, Klingentalmuehle AG, Kaiseraugst, CH; ad libitum
- 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: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Whole-body inhalation system
- Exposure chamber volume: ca. 200 L
- Method of holding animals in test chamber: singly in compartmentalized wire cages in a glass-steel inhalation chamber
- Source and rate of air: room air, 3000 l/h
- Method of conditioning air: via a central air-conditioning system
- System of generating vapour/air: by a piston metering pump KP 2000 (Desaga) and a glass vaporizer with mixer and thermostat (BASF)
- Treatment of exhaust air: the pressure ratios in the inhalation system were adjusted in such a way that the amount of exhaust air was about 6% higher (pressure below atmospheric)
- Temperature, humidity, pressure in air chamber: 19-25 °C


TEST ATMOSPHERE
- Brief description of analytical method used: gas chromatography (GC)
- Samples taken from breathing zone: yes
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
Mean concentration: 21.2 +/-0.5 mg/L (analytical)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The body weight of the animals was checked before the beginning of the test, after 7 days and at the end of the observation period. Clinical findings were recorded several times during exposure and at least once on each workday in the observation period. A check for dead animals was made daily.
- Necropsy of survivors performed: yes
Statistics:
The statistical evaluation of the concentration/effect relationship was carried out on the basis of the binomial test in accordance with tables of the BASF Computer Center.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 21.2 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: 2 of 10 animals died within 24 h after exposure
Mortality:
Within the day 1 post exposure, 1 male and 1 female animal died, during the further observation period no more
animal died.
Clinical signs:
other: - During exposure: all animals showed decreased respiration and apathy after 30 min.; after 1 hour all animals showed additionally an abdominal position. - After exposure and during observation period: direct after exposure the animals were unconscious
Body weight:
The body weight gain of male and female rats in the test group, compared to historical (air) control data , was retarded in the first week of the observation period and adjusted to normal in the second week of the observation period (see table in “Any other information on results”).
Gross pathology:
Animals that died spontaneously (male and female) showed general congestion, sacrificed animals (both sexes) showed no abnormal findings.

Any other information on results incl. tables

Mean body weights (g):

Test Historical Control
Male Female Male Female
Prior to study  256 193 248 177
After 7 days 270 201 285 196
After 14 days 308 221 318 211

Applicant's summary and conclusion