Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not specified
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary source

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2005

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method not reported.

Reference: Gohlke VR, Lewa W, Strachovsky A, et al. 1969. [Animal experimental studies on the inhalatory effects of tributyltin chloride in a subchronic test.] Gezamte Hyg 15:97-104. (German)
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
female

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
not specified
Vehicle:
not specified
Remarks on MMAD:
MMAD / GSD: No data
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
The animals were exposed to concentrations of 4–6 mg/m^3 (0.30–0.45 ppm) for 6 hours/day, 5 days/week for 95 days
Frequency of treatment:
6 hours/day, 5 days/week.
Doses / concentrationsopen allclose all
Dose / conc.:
4 mg/m³ air
Remarks:
4-6 mg/m^3
Dose / conc.:
6 mg/m³ air
Remarks:
4-6 mg/m^3
No. of animals per sex per dose:
No data
Control animals:
not specified

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
Inflamed eyes and nasal mucous membranes were observed in the last month of a 95-day inhalation study of the test material in female rats.
Gross pathological findings:
effects observed, treatment-related
Description (incidence and severity):
Inflammatory changes consisting of hyperaemia and bronchitis were observed in the respiratory system.
Fatty degeneration was observed at necropsy in animals killed after a 95-day exposure period.

Effect levels

Dose descriptor:
LOAEC
Effect level:
3 ppm
Based on:
test mat.
Sex:
female
Basis for effect level:
other: Respiratory, hepatic & ocular effects

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The LOAEL in female rats exposed to the test material was determined to be 3 ppm.
Executive summary:

The LOAEL in female rats exposed to the test material was determined to be 3 ppm.

Effects noted were inflammatory changes consisting of hyperaemia and bronchitis which were observed in the respiratory system.

Fatty degeneration was observed at necropsy in animals killed after a 95-day exposure period. Inflamed eyes and nasal mucous membranes were observed in the last month of a 95-day inhalation study of tributyltin chloride in female rats.