Benzenesulfonic acid and petroleum sulfonic acids, mono- and di-C10-40-(branched and linear)-alkyl derivs., magnesium salts, overbased

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 04 February 1981 and 25 February 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with limited reporting and no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: Section 772 .112-21 CFR 40

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

61789-86-4

IUPAC Name:

61789-86-4

Constituent 2

Reference substance name:

Sulfonic acids, petroleum, calcium salts

EC Number:

263-093-9

EC Name:

Sulfonic acids, petroleum, calcium salts

IUPAC Name:

263-093-9

Details on test material:

Identification: OS#47860
Date received: 28 January 1981

Test animals

Species:

rat

Strain:

other: Sherman-Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

Five groups of five male albino rats of the Sherman-Wistar strain weighing between 200 and 300 gm were employed in this study.
The rats were deprived of food but not water overnight prior to dosing.
The animals were housed and maintained in compliance with the Animal Welfare Act, (Pub. L-94-279) 9 CFR Part 3.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Each animal was weighed and dosed by direct administration of the experimental material into the stomach by means of a syringe and dosing needle.

The sample was dosed as supplied and warmed slightly.

Doses:

The following dosage levels were administered
1.0 gm/kg
2.0 gm/kg.
4.0 gm/kg
8.0 gm/kg,
16.0 mg/kg.

No. of animals per sex per dose:

5 animals per dose, 5 dose groups

Control animals:

no

Details on study design:

Five groups of five male albino rats of the Sherman-Wistar Stain weighing between 200 and 300 gm were employed in this study.
The rats were deprived of food but not water overnight prior to dosing.
Each animal was weighed and dosed by direct administration of the experimental material into the stomach by means of a syringe and dosing needle.
The sample was dosed as supplied and warmed slightly.
The following dosage levels were administered
1.0 gm/kg
2.0 gm/kg.
4.0 gm/kg
8.0 gm/kg,
16.0 mg/kg.
Following administration the animals were allowed food and water ad libitum for the 14 day observation period during which time the rats were observed for signs of toxicity and mortalities.

Statistics:

None recorded.

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 16 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: 95% CL not reported

Mortality:

Two animals died at the 16.0 mg/kg dose level
No mortalites observed at any other dose level
Individual mortality data are given in Table 1 - attachment 1

Clinical signs:

other: 8.0 gm/kg - Within 2 hours the animals were ruffled and slightly depressed. They appeared essentially normal after 24 hours. 16.0 gm/kg - Within 2 hours the animals were ruffled, dirty and depressed. They remained in generally poor health through the firs

Gross pathology:

16.0 mg/kg - Gross pathologic examination revealed nothing remarkable.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The subject material when studied in male albino rats has an acute oral LD50 greater than 16.0 gm/kg.

Executive summary:

To study the acute oral toxicity in rats of the subject material.

Five groups of five male albino rats of the Sherman-Wistar Strain weighing between 200 and 300 gm were employed in this study.

The following dosage levels were administered

1.0 gm/kg

2.0 gm/kg

4.0 gm/kg

8.0 gm/kg

16.0 gm/kg.

Acute Oral Toxicity LD50 Study - the LD50 is greater than 16.0 gm/kg