(xylenes and 4-ethylbenzene)sulfonic acids

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4th quarter 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

- generally similar in dosing principles

Deviations:

yes

Remarks:

numbers of animals per dose was not per guideline and only clinical observations performed

Principles of method if other than guideline:

The study was conducted in two phases. The first, designated a "pilot study", exposed one male and one female to a wide range of doses for 14 days. The second phase, designated the "main study" was a limit test with five males and five females exposed to a single dose for 14 days.

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(Xylenes and 4-ethylbenzene) sulphonic acid

EC Number:

701-247-3

Molecular formula:

-

IUPAC Name:

(Xylenes and 4-ethylbenzene) sulphonic acid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Limited, England
- Age at study initiation: young adults
- Weight at study initiation: 170-210 g
- Fasting period before study: overnight
- Housing: groups of 5 rates of one sex in polythene breeding cages
- Diet (e.g. ad libitum): Oxoid maintainence diet; ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not mentioned

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 50-70
- Air changes (per hr): not mentioed
- Photoperiod (hrs dark / hrs light): 10 / 14

IN-LIFE DATES: From: To: not mentioned

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: required dose
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: soluble in water

MAXIMUM DOSE VOLUME APPLIED: 10 mL

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:

Doses:

pilot study - 15.0, 5.0, 0.50, 0.050 and 0.001 g/kg
main study - 0.51 g/kg

No. of animals per sex per dose:

pilot study - 1
main study - 5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations immediately after dosing, 4 hours after dosing and then daily for 14 days. Weighing only immediately prior to dosing
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs

Statistics:

none

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 510 - < 5 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: 3 of 10 animals died at 510 mg/kg bw

Mortality:

All rats dosed at 15.0 and 5.0 g/kg bw died within 24 hours of dosing. None of the rats dosed at 0.50, 0.050 or 0.001 g/kg bw died within 14 days.
3 of 5 males and 0 of 5 females dosed at 0.51 g/kg bw died between day 2 and day 5.

Clinical signs:

other: The 3 male rats that died following exposure to 0.51 g/kg bw showed signs of pilo-erection within 24 hours of dosing. None of the other animals, at any doses showed overt signs of toxicity.

Gross pathology:

not indicated

Applicant's summary and conclusion

Conclusions:

LD50 >=510 <5000 mg/kg bw based on active ingredient

Executive summary:

The acute Oral Toxicity of Xylene sulphonic acid was assessed following official method OECD 401, Acute Oral Toxicity. The study was conducted in two phases. The first, designated a "pilot study", exposed one male and one female for 14 days with five concentrations (15.0, 5.0, 0.50, 0.050 and 0.001 g/kg). The second phase, designated the "main study" was a limit test with five males and five females exposed to a single dose of 0.51 g/kg for 14 days. Three males dosed at 0.51 g/kg bw died between day 2 and day 5. No mortaility in females. None of the other animals, at any doses showed overt signs of toxicity.