2-chloropropane

Endpoint summary

Description of key information

In a 90-day inhalation study in Sprague-Dawley rats, animals were exposed to isopropyl chloride (IPC) concentrations of 0 (sham control), 250 ppm, 500 ppm, or 1000 ppm for 6 hours/day, 7 days/week for 90 consecutive days.  This GLP study was conducted according to OECD Test Guideline 413.  Following a review of the data, the no-observed-adverse effect concentration (NOAEC) was considered 1000 ppm due to slight decreases in food consumption and body weight at this concentration level.  A no-observed-effect concentration (NOEC) of 500 ppm was established due to the lack of clear-cut toxic effects at this concentration and a lowest-observed-effect concentration

Supportive studies for IPC were not located.  No oral or dermal studies were conducted for this compound.

Key value for chemical safety assessment

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEC

3 252 mg/m³

Study duration:

subchronic

Species:

rat

Additional information

In a key, subchronic, 90-day, GLP, whole-body inhalation study, conducted according to OECD Test Guideline 413, Sprague-Dawley rats were exposed to IPC at nominal concentrations of 0 (sham control), 250, 500, or 1000 ppm (analytical concentrations of 255, 492, and 996 ppm, respectively) for 6 hours/day and 7 days/week (Kaegler, 1993).

There were no IPC-related mortality or changes in the general condition and behavior of the rats and no signs of neurotoxicity were observed. There were no IPC-related findings for ophthalmology, hematology, clinical chemistry, and urine parameters, gross pathology examinations, organ weights, histopathological examinations (including liver and kidneys), and determination of laryngeal epithelial thickness. A slight decrease in food consumption and in body weight gain was observed only for the male rats in the highest (1000 ppm) concentration group. An effect of the test substance with regard to these findings could not be excluded. Based on the data, a NOEC of 500 ppm was derived based on the lack of clear-cut toxic effects of IPC exposure at this concentration. The study author indicated that the 1000 ppm concentration was considered to be at the border of the lowest observed effect concentration determined in the study. Following a review of the data, it was concluded that the decreased food consumption and body weights observed in the 1000 ppm male rats were not adverse. This was based on the small magnitude of the observed changes, the absence of any other test article-related findings, and because a pre-existing 5% lower body weight was noted in 1000 ppm male rats prior to the start of the study. Therefore, the NOAEL for this study was considered to be 1000 ppm (analytical concentration of 996 ppm, corresponding to 3252 mg/m^3 at 1 atm and 20 degrees Celsius).

No supportive studies were located.

Justification for classification or non-classification

The submission substance did not exhibit significant toxic effects arising from a repeated exposure. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.9.