Reaction product of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. and Benzenesulfonic acid, 4-methyl- and sodium hydroxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1989-09-06 to 1989-09-21

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction product of Benzenesulfonic acid, C10-13-alkyl derivs and toluenesulfonic acid and sodium hydroxide

IUPAC Name:

Reaction product of Benzenesulfonic acid, C10-13-alkyl derivs and toluenesulfonic acid and sodium hydroxide

Details on test material:

- Name of test material (as cited in study report): Marlon ARL (Reaction product of Benzenesulfonic acid, C10-13-alkyl derivs and toluenesulfonic acid and sodium hydroxide)
- Physical state: solid (powder)
- Date of production: 1987-03-24
pH (20 g/L): 8 - 10

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 116 g (mean weight)
- Fasting period before study: 16 hours
- Housing: 1 - 5 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 4 - 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

maize oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 12.5 - 25.1 %
- Amount of vehicle (if gavage): 10 cm³/kg

MAXIMUM DOSE VOLUME APPLIED: 10 cm³/kg

DOSAGE PREPARATION (if unusual): The test substance was suspended in maize oil by Ultra-Turrax.

Doses:

1250; 1580; 1990; 2510 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Examination of clinical signs up to 6 hours after the treatment and daily observations thereafter; bodyweights were determined before treatment, and 1, 7 and 14 days after treatment.
- Necropsy of survivors performed: yes
- Other examinations performed: no

Statistics:

The means of the body weights were calculated.
The LD50 was determined according to Litchfield and Wilcoxon and reported with 95% confidence limits (J. Pharmacol. Exp. Ther. 96, 1949, 99)

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 240 mg/kg bw

Mortality:

1250 mg/kg bw: male/female: 0/5
1580 mg/kg bw: male/female: 1/5
1990 mg/kg bw: male/female: 1/5
2510 mg/kg bw: male 4/5; female: 3/5

Clinical signs:

other: Body weight gain was nearly normal. 30 - 60 minutes after exposure the animals showed piloerection and squatting position, later diarrhea, diurese, slight sedation, ataxie, dark eyes, in part loss of weight, gain of motility, hypothermie, some times abdom

Gross pathology:

Sections post mortem showed hyperemie of the gastrointestinal tract mucosa, slight erosion of the stomach mucosa, congestion spleen and in part hyperemie of the renal pelvis. Sections at the end of the study showed in some animals hyperemie of the small intestine mucosa, thickening and conglutinations of the forestomach mucosa, adhesions and conglutinations of the intraabdominal organs and the peritoneum and the diaphragm, 2 animals also had grey-coloured livers and ulceration in the centrum of the conglutinations.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Executive summary:

In an acute orale gavage study on rats according to OECD guideline 401 with Reaction product of Benzenesulfonic acid, C10-13-alkyl derivs and toluenesulfonic acid and sodium hydroxide the estimated LD50 was 2240 mg/kg bw.