Sodium (xylenes and 4-ethylbenzene)sulfonates

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not in report (late 1974 to January 1975)

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:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

10 animals (5 of each sex) dosed over a test chemical range established in initial range finding test; controls included; mortality, symptoms and gross pathology recorded; body weight; recovery period included; LD50 derived using statistical procedure.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium (xylenes and 4-ethylbenzene) sulfonates

EC Number:

701-037-1

Cas Number:

1300-72-7

Molecular formula:

-

IUPAC Name:

Sodium (xylenes and 4-ethylbenzene) sulfonates

Test animals

Species:

rat

Strain:

other: COX-SD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: no data- Age at study initiation: no data- Weight at study initiation: 195 - 334 g- Fasting period before study: overnight- Housing: individually housed in metal, wire-bottom cages elevated above the droppings.- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: no dataENVIRONMENTAL CONDITIONS- Temperature (°C): no data- Humidity (%): no data- Air changes (per hr): no data - Photoperiod (hrs dark / hrs light): no dataIN-LIFE DATES: From: To:no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE- Concentration in vehicle: no vehicle- Amount of vehicle (if gavage):- Justification for choice of vehicle:- Lot/batch no. (if required): - Purity: MAXIMUM DOSE VOLUME APPLIED: no dataDOSAGE PREPARATION (if unusual): not unusualCLASS METHOD (if applicable)- Rationale for the selection of the starting dose: preliminary assay

Doses:

10.02, 12.62, 15.89, 20.00, 25.18 g/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days - Frequency of observations and weighing: daily observations; weighing at end of 14 days- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Statistics:

LD50 using the Method of LItchfield and Wilcoxon (J. Pharmacol. Exptl. Therap., 96: 99, 1949)

Results and discussion

Preliminary study:

no data

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 16.2 other: g/kg/bw

Based on:

test mat.

95% CL:

>= 14 - <= 18.6

Mortality:

No mortality at 10.02 g/kg; 20% mortality at 12.62 g/kg; 40% mortality at 15.89 g/kg; 80% mortality at 20 g/kg; 100% mortality at 25.18 g/kg

Clinical signs:

other: animals at all exposure levels exhibited one or more of the following gross signs of toxicity: weakness, oily ventral skin and hair and prostration. These signs appeared within 24 hours. The signs are absent from survivors after 96 hours.

Gross pathology:

Gross necropsy of animals which succumbed showed severe congestion of the liver, kidneys, adrenal glands and gastrointestinal tract. Gross necropsy of animals sacrificed at termination showed slight to moderate congestion of the adrenal glands.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 for male and female rats is greater than 16.2 mg/kg bw corresponding to 6.48 mg/kg bw based on active ingredient.

Executive summary:

The acute Oral Toxicity of Sodium (xylenes and 4-ethylbenzene) sulfonates was assessed following official method OECD 423, Acute Toxic Class Method. The test was performed with doses of 10,02; 12,62; 15,89; 20,00; 25,18 g/kg bw based on test material administered to both males and females rats.

Mortality occurred at 12.62 g/kg; at 15.89 g/kg; at 20 g/kg and at 25.18 g/kg where all the animals died. Gross necropsy of animals which succumbed showed severe congestion of the liver, kidneys, adrenal glands and gastrointestinal tract in addiction to slight to moderate congestion of the adrenal glands.