2-hydroxybenzoic acid 2-butyloctyl ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 April 1996 to 19 April 1996 (in life)

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Federal Hazardous Substances Act (USA) - 16 CFR 1500.3(c)(2)(i)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

431-090-3

EC Name:

-

Cas Number:

190085-41-7

Molecular formula:

C19 H30 O3

IUPAC Name:

2-butyloctyl 2-hydroxybenzoate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A USDA licensed supplier
- Weight at study initiation: male, 200-300 g; female, 200-300 g
- Fasting period before study: 18 hours
- Housing: in suspended stainless steel wire mesh cages in a temperature controlled room
- Diet (ad libitum): standard laboratory feed for rodent
- Water (ad libitum): city water
- Acclimation period: at least 4 days prior to the start of testing


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 70 deg F +/- 2 deg F


IN-LIFE DATES: From: 5 April 1996 To: 19 April 1996

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test material was used as received. The test substance was measured by syringe and dosed via syringe and intubation tube. The dose was calculated as follows:

Dose Volume (ml) = Animal Weight (kg) x Dose (g/ml) / Test Material Density or Concentration (g/ml)

Doses:

5000 mg/kg bwt

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Test Duration/Observations:

Animals were examined immediately after dosing, 4 hours after dosing, and then twice daily for a maximum of 14 days.

Animal Preparation:

The rats were fasted overnight for approximately 18 hours prior to dosing. Water was available ad libitum.

Types of Observations:

Cageside observations included: skin and fur, eyes and mucous membrane, respiratory system, circulatory system, autonomic and central nervous system, behavior pattern and the onset of tremor, convulsions, salivation, lethargy, sleep and coma.

Gross Pathology:

This was performed on all animals at the time of death. All gross pathological observations were recorded.

Analysis of Data:

The animal's response when exposed to the test substance will include the incidence, severity and reversibility of the following: behavior abnormalities, clinical abnormalities, gross lesions, body weight changes, effects on mortality, and any other toxicological effects.

Evaluation:

As defined in FHSA 16 CFR 1500.3(c)(2)(l), if a dose of 5 g/kg bwt produces no compound related mortality in 5 or more animals, the test material is not considered toxic.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality occurred during the course of this study.

Clinical signs:

other: At 4 hours post dosing and on days 1 and 2, all animals had yellow anogenital staining. On days 3 and 4, a single female had yellow anogenital staining and appeared dehydrated on day 3. There were no other clinical observations noted.

Gross pathology:

There were no gross abnormalities observed in any of the animals at necropsy.

Applicant's summary and conclusion

Conclusions:

The submitted test material when administered as supplied at a single oral dosage level of 5 g/kg bwt did not produce compound-related mortality in half or more of the animals; therefore, the test material is not considered toxic according to definitions listed in the FHSA - 16 CFR 1500.3(c)(2)(l).