1,2-Benzenediol, 4-(2-hydroxyethyl)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Justification for type of information:

acute oral toxicity test (limit dose) equivalent to Method EC B1.tris/OECD 423 Acute Toxic Class method was carried out by a GLP accrediated CRO but data was in publication format

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

acute oral toxicity test (limit dose) equivalent to Method EC B1.tris/OECD 423 Acute Toxic Class method is available

Deviations:

not specified

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

4-(2-hydroxyethyl)benzene-1,2-diol

EC Number:

600-704-3

Cas Number:

10597-60-1

Molecular formula:

C8H10O3

IUPAC Name:

4-(2-hydroxyethyl)benzene-1,2-diol

Specific details on test material used for the study:

The chemical synthesis of DOPET was performed according to Baraldi et al. (1983), with some modifications. A solution of 3,4-dihydroxyphenylacetic acid (3.5 g, n anhydrous tetrahydrofuran (50 ml) was added dropwise to an ice-cooled stirred suspension of LiAlH4 (2 g, 0.054 mol) and Pt on activated
carbon in anhydrous tetrahydrofuran (150 ml). The resulting mixture was heated 6 h at reflux temperature, cooled, and the excess of hydride was
destroyed by addition of 150 ml of 1 N HCl. To the final mixture, 100 ml of ethyl acetate were added. The organic layer was separated, and the aqueous
phase was extracted with ethyl acetate (3 ! 100 ml). The combined organic phases were dried with sodium sulfate and evaporated “in vacuum”, and the
residue was purified on a silica gel column (petroleum ether/ethyl acetate, 1:1 v/v) to give a colorless oil (2.4 g). The yield was about 70%. DOPET was
identified by 1 H and 13C NMR. 1H NMR in CD3OD: 6.75 (1H, d; J " 8.1 Hz), 6.73 (1H, d; J " 2.0 Hz), 6.59 (1H, dd; J # 8.1, J " 2.0 Hz), 3.75 (2H, t; J "
7.5 Hz). 13C NMR: 146.0 (s), 144.4 (s), 131.7 (s), 121.2 (d), 117.0 (d), 116.2 (s), 64.5 (2C, t), 39.5 (2C, t). Infrared (film); 3400, 1600 cm1. The infrared
spectra were taken on a PerkinElmer 1760-X IFT spectrophotometer in film (PerkinElmer Optoelectronics, Santa Clara, CA). The 1 H (500 MHz) and 13C
(125 MHz) NMR spectra were recorded on a Fourier-transform Bruker spectrometer AMX 500 equipped with a Bruker X-32 computer (Bruker, Newark,
DE), using the UXNMR software package. To prevent oxidation, the compound was routinely stored under vacuum.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

They were acclimatized at least 5 days before starting the test and fasted about 16 h before the experiment. Three hours after treatment diet was available “ad libitum”. During the study period, rats were housed under controlled environmental conditions. Animals were main tained and handled according to the Directive 86/609/EEC, enforced by the Italian D.L. No. 116 January 1992. The rats were observed and weighed daily, after administration of DOPET, until day 14. At the end of the test, rats were sacrificed, and gross pathological changes in main organs were evaluated.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

A single dose of 2 g/kg b.wt. DOPET was administered by gavage.

No. of animals per sex per dose:

6 Male/6 Female

Control animals:

no

Statistics:

Toxicity was determined from the death/survival ratio of treated animals.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

not determinable due to absence of adverse toxic effects

Mortality:

The animals were observed and weighted daily for 2 weeks. During the study period, no death occurred in the treated animals

Clinical signs:

other: the only clinical sign observed in males and females was piloerection, which started 2 h after gavage and disappeared within 48 h from treatment

Gross pathology:

autoptic analysis failed to show appreciable macroscopic alterations of internal organs.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The absence of adverse effects at concentrations as high as 2 g/kg b.wt. does not allow the calculation of the LD50 value