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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
Study period:
not reported.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Sachsse et al. 1973
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Tif RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Rasied on the premesis of Ciba-Giegy
- Age at study initiation: NDA
- Weight at study initiation: 180 - 200 g
- Fasting period before study: NDA
- Housing: The males and females were segregated and kept in Macrolon cages, type 4, (9 animals to a cage).
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 ºC
- Humidity (%): 55 ± 5 %
- Air changes (per hr): NDA
- Photoperiod (hrs dark / hrs light): NDA

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
other: ethanol
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: For inhalation the rats were kept on separate PVC tubes positioned radially around the exposure chamber such that snout and nostrils of the animals only were exposed to the aerosol.
- Exposure chamber volume: NDA
- Method of holding animals in test chamber: NDA
- Method of conditioning air: NDA
- System of generating particulates/aerosols: A 20 % aethanol solution of the substance was generated and injected at a rate of 3, 6 and 12 ml/hr into an air stream which was discharged into the exposure chamber through a spray nozzle under a pressure of 2 atm. at a rate of 10 L/min
- Rate of air flow: 10 L/min
- Method of particle size determination: The size distribution of the aerosol particles was measured with a Cascade Impactor with selectron filters of 25 mm diameter and with a pore size of 0.2 um (Schleicher and Schuell) at an air flow rate of 17.5 L/min.


TEST ATMOSPHERE
- Brief description of analytical method used: The concentration and the particle size distribution of the aerosol in the vicinity of the animals was monitored at 1 hour intervals throughout the aerosol exposure. The concentration was determined gravimetrically by sampling the test atmosphere through a selectron filter of 50 mm diameter and with a pore size of 0.2 um (Schleicher and Schuell, Feldbach, Switzerland) at an air flow rate of 10 L/min.


VEHICLE
- Composition of vehicle (if applicable):ethanol
- Concentration of test material in vehicle (if applicable): 20 %
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
221 ± 53 mg/m^3
443 ± 47 mg/m^3
696 ± 103 mg/m^3
No. of animals per sex per dose:
9
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Throughout observation period
- Necropsy of survivors performed: yes
- Other examinations performed: Physical condition and incidence of death were monitored
Statistics:
None reported

Results and discussion

Preliminary study:
N/A
Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
439 mg/m³ air (analytical)
95% CL:
>= 394 - <= 489
Exp. duration:
4 h
Mortality:
See table 1
Clinical signs:
After the 4-hour exposure period the rats in all concentrations showed dyspnoea, tremor, lateral or ventral position and ruffled fur. These symptoms became more accentuated as the concentration was increased.
Body weight:
NDA
Gross pathology:
Dead animals - Hemorrhages of the lungs and congested organs were seen.
Killed animals - No substance related gross organ changes were seen.
Other findings:
NDA

Any other information on results incl. tables

Table 1: Rate of deaths

Concentration

(mg/m3)

Exposure Time (hrs)

No. of animals

Died Within

0 – 4 hours

24 hours

48 hours

7 days

14 days

M

F

M

F

M

F

M

F

M

F

M

F

221 ± 53

4

9

9

0

0

0

0

0

0

0

0

0

0

443 ± 47

4

9

9

4

2

5

3

5

3

5

4

5

4

696 ± 103

4

9

9

9

9

9

9

9

9

9

9

9

9

Applicant's summary and conclusion

Interpretation of results:
toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LC50 of a 4 hour aerosol exposure for rats of both sexes is 439 (394-489) mg/cubic-metre air, when evaluated for a 14 day post-treatment observation period. This value according to the classification of Sachsse et al. (1973) indicates a medium acute inhalation toxicity for the rat.
Executive summary:

In an acute inhalation toxicity study (project number Siss 5354), groups of male and female Tif RAIf (SPF) rats were exposed by inhalation route to dioctyltin dichloride in ethanol for 4 hours at analytically determined concentrations of 221, 443 and 696 mg/m3.  Animals then were observed for 14 days.

 

LC50 Rats = 439 mg/cubic-metre air (95% C.L of 394 and 489 mg/cubic metre air)