Registration Dossier

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 to OECD TG 401 and the report contains sufficient information to permit a meaningful evaluation of study results.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): UCAR N-pentyl propionate
- Molecular weight: 144.2
- Physical state: clear colourless, low viscosity liquid
- Analytical purity: 99+ %
- Impurities (identity and concentrations): < 1%
- Lot/batch No.: BRRC Sample No. 51-19
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in-house
- Age at study initiation: adults
- Weight at study initiation: 200-300 grams
- Fasting period before study: overnight fasting before dosing
- Housing: group housed
- Diet (e.g. ad libitum): commercial diet, ad libitum
- Water (e.g. ad libitum): municipal water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The animals are administered the test material by stomach intubation with a ball-end stainless steel needle. The samples are adminsitered through the needle by means of a syringe and doses are varied by adjusting the volume of the test material or its dilution.
Doses:
16 and 8 ml/kg
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 and animals were weighed on days 0, 7 and 14 of the study
- Necropsy of survivors performed: yes
Statistics:
LD50 and the estimated LD50 slopes were calculated by the moving average method

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Conversion from ml/kg to mg/kg resulted in - 16 ml/kg - 13920 mg/kg (based on density of 0.87)
Mortality:
Males - 2 out of 5 animals were found dead on day 1 and
Females - 1 out 5 animal was found dead on day 2
Clinical signs:
Males - Unsteady gait was noted at 1.5 hours post dosing; sluggishness (marked in 2 rats) at 2.0 hours and red crust on perinasal fur at day 1. Brown stain on perigenital fur was noted in 2 rats at day 1. Survivors recovered around 2-3 days.
Females - Sluggishness, unsteady gait (marked in 2 rats) was noted at 2.0 hours post dosing and survivors recovered around 1-2 days.
Body weight:
Body weight gain was noted in all surviving animals of the treated dose groups
Gross pathology:
In those animals found dead changes such as mottling of lungs and kidneys, liquid and gas filled stomach were noted, while in the surviving animals there were no changes noted attributable to test material administration.
Other findings:
None

Any other information on results incl. tables

Conversion of values from ml/kg to mg/kg resulted in -

16 ml/kg - 13920 mg/kg and 8 ml/kg - 6960 mg/kg (based on density of 0.87)

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 oral LD50 of the UCAR n-pentyl propionate to Sprague Dawley rats was greater than 16 ml/kg (equivalent to 13920 mg/kg) and would not be classified as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.
Executive summary:

Groups of 5 male and 5 female Sprague Dawley rats (adults, weighing between 200-300 grams) were administered UCAR n-pentyl propionate (undiluted) at doses of 16 and 8 ml/kg and observed for mortality and clinical signs of toxicity for 14 days. Two of 5 male rats and one of 5 female rats died after receiving peroral doses of 16.0 ml/kg of N-pentyl propionate. None of 5 male or 5 female rats died from a dosage of 8.0 ml/kg. Signs of toxicity included sluggishness (marked in some), an unsteady gait and red to brown staining on the perinasal or periurogenital fur. Deaths occurred at one to 2 days. Survivors recovered at one to 3 days. Necropsy of victims revealed mottled and dark red lungs (in one); stomachs filled with gas and/or clear liquid; red, white and/or grey stomachs; red intestines (in one); mottled and grey kidneys; and one bladder distended with clear to yellow liquid. No remarkable gross lesions were evident in survivors. Under the conditions of the study, the oral LD50 of the UCAR n-pentyl propionate to Sprague Dawley rats was greater than 16 ml/kg (equivalent to 13920 mg/kg) and would not be classified as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.