Benzyl 4-hydroxybenzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data from study report

Data source

Reference

Reference Type:

publication

Title:

Range-Finding Toxicity Data: List VI

Author:

Henry F. Smyth Jr., Charles P. Carpenter, Carrol S. Well, Urbano C. Pozzani & Jean A. Striegel

Year:

1962

Bibliographic source:

American Industrial Hygiene Association Journal, 1962, 23:2, 95-107

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as per mentioned below

Principles of method if other than guideline:

Acute oral toxicity test was performed on mice by oral route

GLP compliance:

no

Test type:

other: No data

Test material

Test material information

Constituent 1

Reference substance name:

Benzyl 4-hydroxybenzoate

EC Number:

202-311-9

EC Name:

Benzyl 4-hydroxybenzoate

Cas Number:

94-18-8

Molecular formula:

C14H12O3

IUPAC Name:

benzyl 4-hydroxybenzoate

Details on test material:

- Name of test material (as cited in study report): 1 tridecyl alcohol
- Molecular formula (if other than submission substance): C13H28O
- Molecular weight (if other than submission substance): 200.3632
- Substance type: Organic
- Physical state: Liquid

Test animals

Species:

rat

Strain:

other: Carworth -Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Source: No data
Age at study initiation: 4 -5 weeks
Weight at study initiation: 90 -120g
Fasting period before study: No fasting
Housing: No data
Diet (e.g. ad libitum): weaning Rockland rat diet
Water (e.g. ad libitum): No data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: gastric intubation of either the undiluted material or a solution in water or corn oil or as an agar suspension.

Details on oral exposure:

VEHICLE
Concentration in vehicle: No data
Amount of vehicle (if gavage): No data
Justification for choice of vehicle: No data
Lot/batch no. (if required): No data
Purity: No data

MAXIMUM DOSE VOLUME APPLIED:
No data
DOSAGE PREPARATION (if unusual): No data

CLASS METHOD (if applicable)
Rationale for the selection of the starting dose:
Doses were given in a logarithmic series differing by a factor of 2.

Doses:

Doses were given in a logarithmic series differing by a factor of 2.

No. of animals per sex per dose:

Groups of 5 male rats

Control animals:

not specified

Details on study design:

Duration of observation period following administration: 14 days (or other?): 14 days
Frequency of observations and weighing: No data
Necropsy of survivors performed: yes/no: No data

Statistics:

The most probable LD50 value and its fiducial range are estimated by the method of Thompson, using the Tables of Weil. The figures in parentheses show limits of ± 1.96 standard deviations while the absence of parentheses indicates that no range is calculable because no dosage resulted in fractional mortality

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

22 910.4 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were observe

Clinical signs:

other: To toxic effect was observe

Gross pathology:

No data available

Other findings:

No data available

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Acute Oral toxicity studies were carried out to estimate the toxicity of Tridecanol
In the acute oral study conducted in Carworth - Wistar rats, the acute oral LD50 (with± 1.96 standard deviations) for tridecyl alcohol was found to be 2290.4 mg/kg (17.2ml/kg) ( range 16383.6 - 31834.8 mg/kg (12.3 – 23.9ml/kg)).

Executive summary:

Acute Oral toxicity studies were carried out to estimate the toxicity of Tridecanol

Single oral dose toxicity is estimated by the gastric intubation of groups of five non-fasted, Carworth-Wistar male rats, four to five weeks of age and 90 to120 grams in weight which have been reared in our own colony and maintained from time of weaning on Rockland rat diet, complete.The dosages are arranged in a logarithmic series differing by a factor of two. Whenever possible, the chemical is administered undiluted form.The most probable LD50 value and its fiducial range are estimated by the method of Thompson, using the Tables of Weil. The figures in parentheses show limits of ± 1.96 standard deviations while the absence of parentheses indicates that no range is calculable because no dosage resulted in fractional mortality

In the acute oral study conducted in Carworth - Wistar rats, the acute oral LD50(with± 1.96 standard deviations)for tridecyl alcohol was found to be 2290.4 mg/kg (17.2ml/kg) ( range 16383.6 - 31834.8 mg/kg (12.3 – 23.9ml/kg)).