Benzenesulphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

other: Read Across from analogue substance

Adequacy of study:

key study

Study period:

Aug 25 - Sept 27, 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

p-toluenesulfonic acid

IUPAC Name:

p-toluenesulfonic acid

Constituent 2

Reference substance name:

Toluene-4-sulphonic acid

EC Number:

203-180-0

EC Name:

Toluene-4-sulphonic acid

Cas Number:

104-15-4

Molecular formula:

C6H8O3S

IUPAC Name:

4-methylbenzene-1-sulfonic acid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG colony
- Age at study initiation: males - 7 weeks, females - 8 weeks
- Weight at study initiation: males - 194-202 g; females 181-196 g
- Fasting period before study: overnight
- Housing: in groups of 5
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): not provided
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: August 25 To: September 27, 1988

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

1250, 1600 and 2000 mg/kg for females; 2000 mg/kg for males

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 28 days
- Frequency of observations and weighing: observations daily starting on day of exposure; body weight weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:

Statistics:

Probit analysis

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 410 mg/kg bw

Based on:

act. ingr.

Mortality:

2 of 5 males at 2000 mg/kg; 2 of 5, 3 of 5, and 4 of 5 females died at 1250, 1600 and 2000 mg/kg, respectively. Death almost always occurred within one day of dosing.

Clinical signs:

other: Main clinical signs were hypoactivity, hunched posture, irregular breathing in all animals at all doses on day 1 and then reversible within 3 days for males at 2000 mg/kg and within 2 days for females at 1250 mg/kg. For females at 1600 and 2000 mg/kg the

Gross pathology:

Red discolouration of the GI tract filled with blood; white discouloration of the mucosa of the stomach and intestine; pale adrenals, stomach haemorrhages and abdomen filled with flied (in animals that died spontaneously). No sex specific differences.

Other findings:

NOAEL = 1250 mg/kg bw

Any other information on results incl. tables

Mortality: number of deaths at each dose: 2/5, 3/5 and 4/5 at 1250, 1600 and 2000 mg/kg for females, and 2/5 at 2000 mg/kg for males.

Time of death was Day 1 for all but one animal at 1600 mg/kg that died on day 13.

Clinical signs: hypoactivity, hunched posture, irregular breathing were observed in all animals from all dose groups on day 1 and was reversible within 3 days for males at 2000 mg/kg. For females, the above symptoms plus abnormal gait, ptosis and piloerection were seen in all animals at 1600 and 2000 mg/kg and were not reversible.

Necropsy findings: Red discolouration of the GI tract filled with blood, white discolouration of the mucosa of the stomach and intestine, pale adrenals, growing together of the stomach and nearby organs, stomach haemorrhages and abdomen filled with fluid (in animals that died).

Applicant's summary and conclusion

Conclusions:

LD50 = 1410 mg/kg bw based on active ingredient
NOAEL = 1250 mg/kg/bw based on active ingredient

Executive summary:

The acute Oral Toxicity of Toluene 4-sulphonic acid was assessed following official method OECD 401, Acute Oral Toxicity. The test was performed with three concentrations (1250, 1600 and 2000 mg a.i./kg for females rats; 2000 mg a.i./kg for males rats) administered by oral gavage. 2 of 5 males at 2000 mg/kg; 2 of 5, 3 of 5, and 4 of 5 females died at 1250, 1600 and 2000 mg/kg, respectively. Death almost always occurred within one day of dosing. Given the predominance of deaths occurring within the day of exposure and the necropsy findings, it is likely that the deaths were a result of the acidity / corrosivity of the test substance. The internal examination findings suggest a secondary effect (i.e., corrosion) rather than a chemical toxicity.