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Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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 401 and the report contains sufficient information to permit a meaningful evaluation of study results
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
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 401 (Acute Oral 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

Constituent 1
Chemical structure
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
- Fasting period before study: fasted overnight before dosing
- Diet (e.g. ad libitum): ad libitum except during fasting
- Water (e.g. ad libitum): ad libitum except during fasting

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Dosage levels differed by a factor of 2 in a geometric series and were reduced until significant signs of toxicity were not observed
Doses:
16.0, 11.3, 8.0 and 4.0 ml/kg - male rats
16.0, 11.3 and 8.0 ml/kg - female rats
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: daily observed for signs of toxicity and body weights noted weekly
- Necropsy of survivors performed: yes
Statistics:
Descriptive statiscal methods were used. LD50 and the estimated LD50 slopes were calculated by the moving average method

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
12.6 mL/kg bw
Based on:
test mat.
95% CL:
10.7 - 14.8
Remarks on result:
other: 11031.3 mg/kg (based on specific gravity of 0.8755)
Sex:
male
Dose descriptor:
LD50
Effect level:
14.1 mL/kg bw
Based on:
test mat.
95% CL:
12.1 - 16.4
Remarks on result:
other: 12344.55 mg/kg (based on specific gravity of 0.8755)
Mortality:
Males - 4/5 rats died in the 16.0 ml/kg dose group and no mortalities were noted at the lower tested doses up to 4 ml/kg.
Females - All animals administered 16.0 ml/kg of n-butyl propionate were found dead, 1 rat from the 11.3 ml/kg group was found dead and no mortalities noted at the lowest test dose of 8 ml/kg
Clinical signs:
other: Signs of toxicity noted were sluggishness (marked in some animals), an unstaedy gait, lacrimation, prostration and a red crust on the perinasal and periocular fur.
Gross pathology:
All mortalities were noted at day one post dosing and survivors recovered from 1-4 days. Necropsy of animals found dead revealed mottled bright-red to dark-red lungs, grey and red or white stomachs filled with clear or red liquid, distended bladders and mottled light grey kidneys. No gross pathological changes attributable to administration of n-butyl propionate were noted in the survivors
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, the LD50 of UCAR n-butyl propionate to male and female Sprague Dawley rats are in excess of 10000 mg/kg and hence 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 oral toxicity.
Executive summary:

UCAR n-butyl propionate (undiluted) was administered to groups of male and female Sprague Dawley rats (young adults weighing between 200-300 grams) and observed for mortality and clinical signs of toxicity. In males - 4/5 rats died in the 16.0 ml/kg dose group and no mortalities were noted at the lower tested doses up to 4 ml/kg, while in females - All animals administered 16.0 ml/kg of n-butyl propionate were found dead, 1 rat from the 11.3 ml/kg group was found dead and no mortalities noted at the lowest test dose of 8 ml/kg. Signs of toxicity noted were sluggishness (marked in some animals), an unstaedy gait, lacrimation, prostration and a red crust on the perinasal and periocular fur. All surviving animals gained body weight during the study period. All mortalities were noted at day one post dosing and survivors recovered from 1-4 days. Necropsy of animals found dead revealed mottled bright-red to dark-red lungs, grey and red or white stomachs filled with clear or red liquid, distended bladders and mottled light grey kidneys. No gross pathological changes attributable to administration of n-butyl propionate were noted in the survivors.

Under the conditions of the study, the LD50 of UCAR n-butyl propionate to male Sprague Dawley rats was 14.1 ml/kg (95% CL - 12.1-16.4; 12344.55 mg/kg) and female Sprague Dawley rats was 12.6 ml/kg (95% CL - 10.7-14.8; 11031.3 mg/kg) 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 oral toxicity.