Acetic acid, C11-14-branched alkyl esters, C13-rich

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 October 1983 - 20 October 1983

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

GLP compliance:

not specified

Test type:

fixed dose procedure

Test material

Test material information

Constituent 1

Reference substance name:

Acetic acid, C11-14-isoalkyl esters, C13-rich

EC Number:

283-740-9

EC Name:

Acetic acid, C11-14-isoalkyl esters, C13-rich

Cas Number:

84712-50-5

Molecular formula:

C15H30O2

IUPAC Name:

Acetic acid, C11-14-isoalkyl esters, C13-rich

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature

OTHER SPECIFICS:
SPECIFIC GRAVITY: 0.874 (SUPPLIED BY SPONSOR)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Taconic Farms, Germantown, NY
- Age at study initiation: Approx 10-12 weeks
- Weight at study initiation: 190 - 334 g
- Fasting period before study: 18 hr
- Housing: Group housed by sex, 5 per suspended stainless steel cage
- Diet: Certified Purina rodent chow (ad libitum).
- Water (e.g. ad libitum): Automatic watering system (ad libitum)
- Acclimation period: 16 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25 °C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): pprox 12 hours light/dark

IN-LIFE DATES: FROM: OCTOBER 6, 1983 TO: OCTOBER 20,

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg

Doses:

5,000 mg/kg

No. of animals per sex per dose:

5 males/females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were examined for viability once in the horning (before approximately 10:30 am) and once in the afternoon (after approximately 3:00 pm). In-life observations were made as to the nature, onset, severity, and duration of toxicological signs 1, 2, 4, and 6 hours after dosing, and once per day thereafter for a total of 14 days. Body weights were recorded the day prior to dosing (pre-dose), at initiation of dosing, at day 7 and day 14.

- Necropsy of survivors performed: yes. After the day 14 observations, all animals were weighed and euthanized by carbon dioxide asphyxiation. Gross necropsies were performed by qualified personnel.

Statistics:

The means and standard deviations of the body weights were calculated.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

There were no animals deaths during this study

Clinical signs:

other: During clinical in-life observations staining in the ano-genital area was noted for 9 of the 10 test animals on days 1 and 2, and for 1 animal on day 3. Soft stool was noted for 1 animal at 6 hours and white gelatinous material on the penis was noted for

Gross pathology:

Gross necropsy observations revealed lung discoloration ranging from a slight amount of dark red foci to mottling of all lobes and surfaces in 4 animals; these are typical findings as a result of carbon dioxide asphyxiation. Six of the 10 test animals exhibited no observable abnormalities during the postmortem examination.

Any other information on results incl. tables

Results tables can be found in the attachment to this RSS

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50> 5,000 mg/kg

Executive summary:

The acute toxicity of the test substance was evaluated when administered by the oral route at 5,000 mg/kg of fasted body weight to 5 male and 5 female rats. The animals were fasted for approximately 18 hours prior to administration of the test material.

 

Observations were made as to the nature, onset, severity, and duration of toxicological signs 1, 2, 4, 3 and 24 hours after dosing, and once per day thereafter for a total of 14 days. Body weights were recorded the day prior to dosing, on the day of dosing, on day 7, and on day 14. After the day 14 observations, all animals were weighed and euthanized by carbon dioxide asphyxiation. Gross necropsies were performed on all animals by qualified personnel.

 

There were no animal deaths noted during the study. The body weights of all but 1 animal increased over the 14 day test period.

 

Clinical in-life observations included a high incidence of ano-genital staining, and a low incidence of soft stool which were not judged to be treatment related. There appeared to be no treatment related abnormalities on postmortem gross examination of the test animals.

 

Note: it appears the predose body weight for this animal may be incorrect.