Sodium 4-hydroxybenzenesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

None

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

Principles of method if other than guideline:

As per guideline

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4-hydroxybenzenesulphonate

EC Number:

212-550-0

EC Name:

Sodium 4-hydroxybenzenesulphonate

Cas Number:

825-90-1

Molecular formula:

C6H6O4S.Na

IUPAC Name:

sodium 4-hydroxybenzenesulphonate

Test material form:

solid

Specific details on test material used for the study:

- Identification: FAT 93588/A TE
- Batch: 0041847900
- Purity: >98 %
- Physical state/Appearance: white solid
- Expiry Date: 01 January 2018
- Storage Conditions: room temperature in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Animal Information
Female Wistar (RccHan™:WIST) strain rats were supplied by Envigo RMS (UK) Limited, Oxon, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non pregnant. After an acclimatization period of at least 5 days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card. At the start of the study the animals were 8 to 12 weeks of age. The body weight variation did not exceed ±20 % of the mean body weight at the start of treatment.

Animal Care and Husbandry
The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately 3 to 4 hours after dosing, free access to mains drinking water and food (2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited, Oxon, UK) was allowed throughout the study. The diet, drinking water and bedding were routinely analyzed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study. The temperature and relative humidity were set to achieve limits of 19 to 25 °C and 30 to 70 %, respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours darkness. The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: for 300 mg/kg bw dose, concentration was 30 mg/mL, while for 2000 mg/kg bw dose, concentration was 200 mg/mL.

MAXIMUM DOSE VOLUME APPLIED: 10 mL

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.

Doses:

Sighting tests - 300 mg/kg bw and 2000 mg/kg bw, main test - 2000 mg/kg bw

No. of animals per sex per dose:

Sighting tests - one animal each, main test; 4 animals

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: twice daily, early and late during normal working days, and once daily at weekends and public holidays
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Day 0 (the day of dosing) and on Days 7 and 14
- Other examinations performed: body weight - Day 0 (the day of dosing) and on Days 7 and 14

Statistics:

Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50) of the test item was made.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: There were no signs of systemic toxicity.

Gross pathology:

No abnormalities were noted at necropsy.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw.

Executive summary:

The acute toxicity potential of FAT 93588/A was evaluated in a study performed according to OECD Guideline 420. Following a sighting test at dose levels of 300 mg/kg bw and 2000 mg/kg bw, a further group of four fasted female Wistar rats was given a single oral dose of test item, as a solution in distilled water, at a dose level of 2000 mg/kg bw. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.

There were no deaths and no signs of systemic toxicity was recorded. All animals treated at a dose level of 2000 mg/kg bw showed expected gains in body weight. The animal treated at a dose level of 300 mg/kg bw showed body weight loss during the first week but expected gain in body weight during the second week. No abnormalities were noted at necropsy. Hence, based on the above findings, the acute oral median lethal dose (LD₅₀) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw (Globally Harmonized Classification System-Unclassified).