Registration Dossier

Diss Factsheets

Administrative data

Description of key information

A supporting study for repeated dose inhalation is avaialable. The LOAEL in female rats exposed to the test material was determined to be 3 ppm in a 95 day inhalation study. Effects noted were; inflammatory changes consisting of hyperaemia and bronchitis observed in the respiratory system. Fatty degeneration was also observed at necropsy in animals killed after the exposure period. Inflamed eyes and nasal mucous membranes were observed in the last month of the study.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records
Reference
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
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
Species:
rat
Strain:
not specified
Sex:
female
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.
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
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.
Dose descriptor:
LOAEC
Effect level:
3 ppm
Based on:
test mat.
Sex:
female
Basis for effect level:
other: Respiratory, hepatic & ocular effects
Critical effects observed:
not specified
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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There is a supporting study for repeated dose inhalation:

For the ASTDR (2005) report a reliability rating of 4 was assigned to this study, according to the criteria of Klimisch, 1997 as this information is from a secondary source. The LOAEL in female rats exposed to the test material was determined to be 3 ppm in a 95 day inhalation study. Effects noted were; inflammatory changes consisting of hyperaemia and bronchitis observed in the respiratory system. Fatty degeneration was also observed at necropsy in animals killed after the exposure period. Inflamed eyes and nasal mucous membranes were observed in the last month of the study.

Justification for classification or non-classification

It should be noted that although there are no reliable data available for repated dose endpoints, as they are not needed for intermediate substances, the results from the supporting inhalation study would suggest that classification for these endpoints should be considered.

With this in mind, it should be noted that the official classification for tributyltin compounds according to regulation (EC) No 1272/2008, Annex VI, Table 3.1 are as follows:

Classification Labelling
Hazard class and category code(s) Hazard statement code(s) Pictogram signal word code(s) Hazard statement code(s)
Acute Tox. 3* H301   H301
Acute Tox. 4* H312   H312
STOT RE 1 H372** GHS06 H372**
Eye Irrit. 2 H319 GHS08 H319
Skin Irrit. 2 H315 GHS09 H315
Aquatic Acute 1 H400 Dgr H410
Aquatic Chronic 1 H410    

Specific concentration limits and M factors
Concentration Classification
* -
STOT RE 1; H372 C ≥ 1 %
STOT RE 2; H373 0,25 % ≤ C < 1 %
Skin Irrit. 2; C ≥ 1 % -
Eye Irrit. 2; C ≥ 1 % -
M = 10 -

Therefore the classification for this endpoint will be STOT RE1; H372: Causes damage to organs through prolonged or repeated exposure, according to regulation (EC) No 1272/2008. No details of specific organs as data taken from Annex VI classification.