Butyl propionate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study methodology followed was equivalent or similar to OECD TG 403 and the report contains sufficient information to permit a meaningful evaluation of study results

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

not applicable

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butyl propionate

EC Number:

209-669-5

EC Name:

Butyl propionate

Cas Number:

590-01-2

Molecular formula:

C7H14O2

IUPAC Name:

butyl propanoate

Details on test material:

- Name of test material (as cited in study report): UCAR n-butyl propionate
- Physical state: clear clolourless low viscosity liquid
- Analytical purity: 99+ %
- Impurities (identity and concentrations): < 1%
- Lot/batch No.: 51-18
- Stability under test conditions: yes
- Storage condition of test material: at room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: assumed to be in-house
- Age at study initiation: young adults
- Weight at study initiation: 200-300 grams
- Diet (e.g. ad libitum): ad libitum except during exposure
- Water (e.g. ad libitum): ad libitum except during exposure

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

not specified

Details on inhalation exposure:

Vapors of UCAR n-butyl propionate were produced by enclosing approximately 100 grams in a sealed 100-151 liters animal chamber for approximately 18 hours (static conditions). A mixing fan was used to periodically agitate the chamber atmosphere to aid in the distribution of vapor. Oxygen was added, as and when needed to maintain a chamber oxygen content of approximately 20%.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

6 h

Concentrations:

substantially saturated vapors

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were recorded daily and body weights recorded on a weekly basis
- Necropsy of survivors performed: yes

Statistics:

Descriptive statistical methods were used.

Results and discussion

Preliminary study:

not applicable

Effect levels

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 23.78 mg/L air

Based on:

other: conversion of saturated vapor concentration (4473.68 ppm, based on saturated vapor concentration of 3.4 mm Hg at 20 °C)

Exp. duration:

6 h

Mortality:

No mortalities were noted

Clinical signs:

other: No clinical signs of toxicity were noted

Body weight:

Normal body weight gain was noted in all the animals

Gross pathology:

No gross pathological changes were noted

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the study as no mortality was observed in rats exposed to substantially saturated vapors (equivalent to 23.78 mg/l air) of UCAR n-butyl propionate and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, UCAR n-butyl propionate will not be classified for acute inhalation toxicity.

Executive summary:

In this study, groups of male and female Sprague Dawley rats were exposed (whole body) to substantially saturated vapor levels of UCAR n-butyl propionate for 6 hours. Vapors of UCAR n-butyl propionate were produced by enclosing approximately 100 grams in a sealed 100-151 liters animal chamber for approximately 18 hours (static conditions). A mixing fan was used to periodically agitate the chamber atmosphere to aid in the distribution of vapor. Oxygen was added, as and when needed to maintain a chamber oxygen content of approximately 20%. Clinical signs were recorded daily and body weights recorded on a weekly basis until day 14. During the study, no mortalities and clinical signs of toxicity were noted. Normal body weight gain was noted in all the animals and no gross pathological changes were noted at termination on day 14.

Under the conditions of the study as no mortality was observed in rats exposed to substantially saturated vapors (equivalent to LC50 > 23.78 mg/l air) of UCAR n-butyl propionate and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, UCAR n-butyl propionate will not be classified for acute inhalation toxicity.