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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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.