Benzoic acid, 4-hydroxy-, 1,1'-(1,4-phenylene) ester

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996-11-7 to 1997-02-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner)

IUPAC Name:

Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner)

Details on test material:

- Name of test material (as cited in study report): Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner)
- Physical state: solid
- Analytical purity: >95%
- Storage condition of test material: At room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charls River, Sulzfeld, Germany
- Age at study initiation: Approx. 6 weeks
- Weight at study initiation: 140-170 (female); 188-195 (male
- Fasting period before study: overnight
- Housing: poly carbonate cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not given in the report


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C
- Humidity (%): 50%
- Air changes (per hr): Approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 1% aqueous CMC (carboxymethyl cellulose)

Details on oral exposure:

- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: Pretests

Doses:

2000 mg/kg (10 mL/kg) bodyweight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Observation period: 15 days
- Frequency of observations and weighing: Recording of signs and symptoms sveral times the day of administration. At least once each day.
- Necropsy of survivors performed: yes

Results and discussion

Preliminary study:

no information

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

none

Clinical signs:

other: no abnormalities

Gross pathology:

no abnormalities

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: not specified

Conclusions:

The LD50 is greater than 2000 mg/kg bodyweight. Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner) was not toxic under the conditions of this test.

Executive summary:

Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner) was testet for oral toxicity in 5 male and 5 female rats with a dose of 2000 mg/kg bodyweight following the OECD Guideline 401 (1987). No mortality or other clinical signs were noted. No abnormalities were found in the animals at macroscopic post mortem examination. The LD50 value of Hydroquinone-bis-p-hydroxybenzoate (OH-Dreikerner) in rats was established as exceeding 2000 mg/kg body weight.