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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:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
The test was carried out in accordance with the below method.

K. Sachsse, L. Ullmann, G. Voss and R. Hess: Measurement of inhalation toxicity of aerosols in small laboratory animals. In: Proceedings of the Europ. Soc. for the Study of Drug Toxicity. Vol. XV, pp. 239-251, Zurich, June 1973.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Raised on testing lab premises
- Weight at study initiation: 170 to 200 g
- Housing: Macrolon cages, type 4, (10 animals to a cage).
- Diet (e.g. ad libitum): NAFAG, Gossau SG ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 55 ± 5
- Photoperiod: 14 hrs dark / 10 hrs light

Administration / exposure

Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
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.

The aerosol was generated by injecting a 50 % aqua test solution of the test material at a rate of 12, 30 and 60 ml/hour 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.

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 µm at an air flow rate of 10 l/min. 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 µm at an air flow rate of 17.5 l/min.
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
44 ± 6, 90 ± 7, 121 ± 3 and 167 ± 23 mg/m³.

Average concentration, gravimetrically determined.
No. of animals per sex per dose:
10 males, 10 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: physical condition and incidence of death
Statistics:
LC 50 including 95 % confidence limits was calculated by probit analysis method.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
115 mg/m³ air (analytical)
Based on:
act. ingr.
95% CL:
105 - 126
Exp. duration:
4 h
Mortality:
44 ± 6 mg/m³ : 0/10 males, 0/10 females within 14 days
90 ± 7 mg/m³ : 3/10 males, 1/10 females within 14 days
121 ± 3 mg/m³ : 5/10 males, 4/10 females within 14 days
167 ± 23 mg/m³ : 10/10 males, 10/10 females within 14 days
Clinical signs:
Within 2 hours after starting the exposure the animals in concentrations where mortalities occurred showed dyspnoea, ventral position, tremor and ruffled fur. These symptoms became more accentuated as the concentration was increased. After the 4 hour exposure period all animals showed, in addition to the above symptoms edepla, in the head region. The surviving animals recovered within 6 to 7 days. They were submitted at random to a necropsy whenever they died, survivors at the end of the observation period.
Body weight:
NDA
Gross pathology:
Dead Animals: Hemorrhages in the lungs were observed.
Sacrificed Animals: No substance related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:
other: Category 2: Fatal if inhaled
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, the LC50 of a 4 hour aerosol exposure for rats of both sexes is 115 (105-126) mg/m³ air when evaluated for a 14 day post-treatment observation period.
Executive summary:

The acute inhalation toxicity of dimethyltin dichloride was examined in a 4 hour study using male and female Tif: RAIf (SPF) rats, in a procedure similar to OECD 403.

Clinical observations included dyspnoea, ventral position, tremor and ruffled fur. These symptoms became more accentuated as the concentration was increased.

Hemorrhages in the lungs were observed in animals which died during the study, but not in those who survived.

The gravimetrically determined average concentrations used were 44 ± 6, 90 ± 7, 121 ± 3 and 167 ± 23 mg/m³.

The LC50 of a 4 hour aerosol exposure for rats of both sexes is 115 (105-126) mg/cm3 air, when evaluated for a 14 day post-treatment observation period.