Propyl propionate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study methodology followed was equivalent or similar to OECD TG 401 and there is no mention in the report on the status of compliance with the Principles of Good Laboratory Practice (GLP).

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:

1989

Report date:

1989

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

Test material information

Constituent 1

Reference substance name:

Propyl propionate

EC Number:

203-389-7

EC Name:

Propyl propionate

Cas Number:

106-36-5

Molecular formula:

C6H12O2

IUPAC Name:

propyl propanoate

Details on test material:

- Name of test material (as cited in study report): n-propyl propionate
- Physical state: colorless, transparent, low viscosity liquid
- Analytical purity: 100%
- Lot/batch No.: 51-535; 52-19 (15RLRX51)
- Storage condition of test material: 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: yes
- Housing: assumed to be group housed
- Diet: ad libitum, appropriate commercial diet, except during the period of fasting
- Water: municipal water, ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Groups of Sprague Dawley rats (both sexes) were administered undiluted n-propyl propionate with a ball-end stainless steel needle.

Doses:

Males - 4.0, 8.0, 11.3 and 16 ml/kg
Females - 8.0, 11.3 and 16.0 ml/kg

No. of animals per sex per dose:

5 rats/dose, except that 2 male rats were administered undiluted n-propyl propionate 4.0 ml/kg dose group

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations and body weights recorded weekly
- Necropsy of survivors performed: yes

Statistics:

LD50's and the estimated LD50 slopes were calculated by the moving average method

Results and discussion

Preliminary study:

not applicable

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

11.7 mL/kg bw

Based on:

test mat.

95% CL:

9.6 - 14.3

Remarks on result:

other: Conversion value of 10258.67 mg/kg based on density of 0.87681 g/cc at 25 °C

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

12.6 mL/kg bw

Based on:

test mat.

95% CL:

10.7 - 14.7

Remarks on result:

other: Conversion value of 11047.80 mg/kg based on density of 0.87681 g/cc at 25 °C

Mortality:

No mortalities were noted in either sex upto 8.0 ml/kg, in the 11.3 ml/kg group - 2 males and 1 female rat were found dead and 100% mortality was noted in the 16.0 ml/kg group.

Clinical signs:

other: Signs of toxicity included sluggishness, an unsteady gait, lacrimation, prostration, a moribund appearance, diarrhea, red crust on the perinasal fur and staining of the periurogenital fur.

Gross pathology:

Necropsy of victims revealed discolored lungs (red, pink or mottled), discolored stomachs (white, grey or dark brown), stomachs with black areas, liquid and/or gas-filled stomachs, liquid-filled intestines, discolored intestines (red, white, yellow or dark brown), intestines with black areas (in 2), mottled tan to dark red livers, mottled tan to dark red kidneys, red discharge on the periurogenital fur and bladders filled with yellow or red liquid. The only gross pathologic finding for survivors was mottled dark red kidneys (in 2).

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 the oral LD50 of n-propyl propionate is in excess of 10000 mg/kg, hence based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-propyl propionate will not be classified for acute oral toxicity.

Executive summary:

In this study, groups of Sprague Dawley rats (weighing between 200-300 grams) were administered undiluted n-propyl propionate by oral gavage and observed for signs of toxicity and mortality over a period of 14 days. No mortalities were noted in either sex upto 8.0 ml/kg, in the 11.3 ml/kg group - 2 males and 1 female rat were found dead and 100% mortality was noted in the 16.0 ml/kg group. Signs of toxicity included sluggishness, an unsteady gait, lacrimation, prostration, a moribund appearance, diarrhea, red crust on the perinasal fur and staining of the periurogenital fur. Weight gain was noted in all the surviving animals. Necropsy of victims revealed discolored lungs (red, pink or mottled), discolored stomachs (white, grey or dark brown), stomachs with black areas, liquid and/or gas-filled stomachs, liquid-filled intestines,  discolored intestines (red, white, yellow or dark brown), intestines with black areas (in 2), mottled tan to dark red livers, mottled tan to dark red kidneys, red discharge on the periurogenital fur and bladders filled with yellow or red liquid. The only gross pathologic finding for survivors was mottled dark red kidneys (in 2).

Under the conditions of the study, as the oral LD50 of n-propyl propionate is in excess of 10000 mg/kg (male LD50 – 11.7 ml/kg ~ 10258.67 mg/kg and female LD50 – 12.6 ml/kg ~ 11047.80 mg/kg; conversions based on density of 0.87681 g/cc at 25 °C), hence based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-propyl propionate will not be classified for acute oral toxicity.