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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:
supporting study
Study period:
June 1979
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
abstract

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1979
Reference Type:
other company data
Title:
Unnamed
Year:
1979

Materials and methods

Principles of method if other than guideline:
2-hour whole body exposure
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): 8α,-12-Oxido-13,14,15,16-tetranorlabdan / Ambroxan
- Physical state: liquid (supplied as a solution in the vehicle)
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Züchter Winkelmann GmbH, D Borchen
- Age at study initiation: adult
- Weight at study initiation: 130 -150 g
- Fasting period before study: no, but food and water were withdrawn during exposure
- Housing: Makrolon tyoe 3
- Diet (e.g. ad libitum): Altromin maintenance diet Nr. 1324
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 50
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
whole body
Vehicle:
other: Ethanol (40%)
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- System of generating particulates/aerosols: the substance solution is nebulized with an atomizer and spray mist is introduced into the experimental animal room. The effluent air stream is passed through a gas meter after filtering and the flow rate is measured
No other data
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
2 h
Concentrations:
1 %
No. of animals per sex per dose:
5 males / dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes, trachea and lung were removed for histological examinations (3 animals per group)
Statistics:
None

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male
Dose descriptor:
LC50
Effect level:
> 1 other: % (nominal)
Based on:
test mat.
Exp. duration:
2 h
Mortality:
None
Clinical signs:
other: Fast passing decrease of the general well-being after the end of the exposure constituted the sole symptom.
Body weight:
No data
Gross pathology:
A mild subacute to chronic tracheitis was present in the air-tubes of all animals (i.e. treated and control). The lungs had moderate to severe interstitial pneumonia usually focal, which was also associated with subacute to chronic bronchitis and / or bronchopneumonia. No compound-specific alterations of the target organs (respiratory tract) were observed.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Conclusions:
LC 50 (2h) > 1 % (nominal)
Executive summary:

In an acute inhalation toxicity study adult Wistar rats (5 males/group) were exposed by inhalation route to Ambroxan in Ethanol (40%) for 2 hours to whole body at concentrations of 1 %. Animals then were observed for 14 days.

LC50 Males > 1 % (nominal)

Fast passing decrease of the general well-being after the end of the exposure constituted the sole symptom.

No compound-specific alterations of the target organs (respiratory tract) were observed.

Due to the general lack of details included the study report, this study is not considered as self-sufficient to satisfy the requirement for acute inhalation toxicity endpoint