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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
yes
Remarks:
exposure time only 1 hour
Principles of method if other than guideline:
Dynamic inhalation method; whole-body - head/nose exposure with analytical and nominal concentration determination.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Mean body weight: 200 - 300 g
The animals were held in air-conditioned rooms with a room temperature of 22 +/- 2°C and a relative humidity of 55 +/- 10%.
Air changing: 10- to 15-fold
Day/night rhythm: 12 h dark, 12 h light
Type of cage: Makrolon type 3 (23 x 39cm2)
Animals per cage: 2
Animal identification: via ear marks
The animals were offered a standard animal laboratory diet as well as drinking water ad libitum.
TEST ANIMALS
- Weight at study initiation: 200-300 g
- Housing: 2 animals per cage, Makrolon type 3 (23 x 39cm2)
- Diet: standard animal laboratory diet, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): of 22 +/- 2°C
- Humidity (%): 55 +/- 10%.
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Makrolon animal tubes
- Exposure chamber volume: 28.5 L
- Source and rate of air: continuous airation, 600 L/h
- System of generating particulates/aerosols: diffuser nozzle

TEST ATMOSPHERE
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
1 h
Concentrations:
4.5 and 10.1 mg/L (nominal)
No. of animals per sex per dose:
10
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.5 - < 10.1 mg/L air
Based on:
test mat.
Exp. duration:
1 h
Remarks on result:
other: by applying Habers' law (c x t = k) for time extrapolation (1 h to 4 h exposure): LC50 > 1.1 < 2.5 mg/L air
Mortality:
4.5 mg/L: no mortality
10.1 mg/L: all animals died
Clinical signs:
During exposure:
In the lowest concentration male and female rats showed a slight reduced spontaneous activity as well as a slight reduced rection of outer stimuli; furthermore slight gasping, slight constricted palpebral fissures and slight increased salivation.
In the highest concentration, male and female animals showed a intense reduced breathing rate and gasping, slight to severe cyanotic skin, constricted palpabral fissures and severe salivation. 4 hours after begin of inhalation all animals were free of symptoms.
During the observiation period:
In the low concentration male and female rats showed a slight reduced spontaneous activity as well as a slight reduced reaction of outer stimuli, furthermore gasping and slight constricted palpebral fissures.
4 hours after study start all animals were without findings.
Body weight:
not examined
Gross pathology:
Animals that died (high concentration): 10 of 20 rats showed the following changes of the lung: alveolar emphysema, petechiae and focal atelectasis.
Sacrificed animals: 1 of 20 rats showed isolated petechia (low concentration).

Applicant's summary and conclusion