Naphthalenesulfonic acid, di-C9-rich C8-10-branched alkyl derivs., barium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was conducted prior to GLP regulations but used methods generally consistent with accepted procedures. More animals were used than required by current protocols and a good dose-response and statistically valid LD50 value were obtained.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

barium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)

EC Number:

939-718-2

Cas Number:

1474044-80-8

Molecular formula:

C28H44O3S.1/2Ba

IUPAC Name:

barium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)

Test material form:

other: as solution in light paraffinic and naphthenic petroleum distillates

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

Rats derived from Royalhart Colony.
Rats were fasted 18 hours before dosing and then individually and singly dosed by gavage.

Doses:

2,3,4,5, and 6 ml/kg bw

No. of animals per sex per dose:

5 males
5 females

Control animals:

no

Details on study design:

Five groups of 5 male and 5 female rats, weighing 200-300 grams, were used in each of 5 treatment groups.

Statistics:

LD50 calculated by Litchfield-Wilcoxin Method of Probit Analysis

Results and discussion

Preliminary study:

A separate study (T-399) was conducted earlier (July 10, 1978) with a single dose of 5 dose of 5 grams / kg bw.
10 male rats (207 - 294 grams) were used. 7 of 10 (70%) of the treated rats died.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 3.5 mL/kg bw

Based on:

test mat.

95% CL:

>= 2.8 - <= 4.3

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 750 mg/kg bw

Based on:

act. ingr.

Mortality:

see attached table
Oral LD50 : 3.5 ml/kg 95% confidence limits 2.8-4.3 ml/kg

Clinical signs:

other: Not reported

Gross pathology:

see attached table

Any other information on results incl. tables

Group	Dose ml/kg-bw	Male	Female	% Mortality
1	2	0/5	2/5	20
2	3	1/5	2/5	30
3	4	3/5	3/5	60
4	5	2/5	4/5	60
5	6	5/5	4/5	90

 

Clinical Observation	2 mg/kg No. Animals	3 mg/kg No. Animals	4 mg/kg No. Animals	5 mg/kg No. Animals	6 mg/kg No. Animals
Discolored Spleen	1	1	1	2	5
Discolored Liver	1		3	3	8
GI Tract Hemorrhage		1
Ocular Hemorrhage			1	3	1
Subcutaneous Hemorrhage	1			1
Lung Hemorrhage	1	2	5	5	7
No. Animals Examined	10	10	10	10	10

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Oral LD50 = 3.5 ml/kg bw (as tested formulation)
Oral LD50 = 1750 mg/kg bw (based on 50% purity)

Executive summary:

Five male and 5 female rats were dosed with the test substance at 2, 3, 4, 5, and 6 ml/kg bw.

The calculated oral LD50 is 3.5 ml/kg bw.

The oral LD50 is 1750 mg/kg bw (based on 50% purity of formulation).

The following mortality was observed:

Group	Dose ml/kg-bw	Male	Female	% Mortality
1	2	0/5	2/5	20
2	3	1/5	2/5	30
3	4	3/5	3/5	60
4	5	2/5	4/5	60
5	6	5/5	4/5	90