Magnesium bis(dinonylnaphthalenesulphonate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 2 - 26, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited report, non GLP. Sufficient to allow a conclusion on the LD50 value. The information in the report is limited to the information in the summary.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: FHSLA, CFR Title 21, para. 191.1.

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Magnesium bis(dinonylnaphthalenesulphonate)

EC Number:

248-777-7

EC Name:

Magnesium bis(dinonylnaphthalenesulphonate)

Cas Number:

28015-99-8

Molecular formula:

Mg[C28H43O3S]2

IUPAC Name:

magnesium bis(dinonylnaphthalenesulphonate)

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Taconic Farms
- Age at study initiation: not reported
- Weight at study initiation: Males: 212-290 g; Females: 200-234 g
- Fasting period before study: 18 hours prior to dosing
- Housing: individually
- Diet: Fisher Rat Chow ad libitum
- Water: ad libitum
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Remarks:

in 3/10 animals

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%

MAXIMUM DOSE VOLUME APPLIED: 5.0 mL

Doses:

2500 mg/kg bw (calculated from dosing volume)

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated (weighing at start and end of study reported)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Statistics:

NA

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

act. ingr.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Mortality:

2 of 5 females died on day 1

Clinical signs:

none reported

Body weight:

within expected ranges (except in deceased animals)

Gross pathology:

Pulmonary Hemorrhage; Bloated Gastro-Intestinal Tract in decendents

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the testsubstance is > 2500 mg/kg bw

Executive summary:

Five rats/sex received a dose of ca. 2500 mg/kg bw of the test substance. Two females died on day 1. Other animals survived until the end of the 14 day observation period. No effects on body weight, clinical signs and macroscopic findings were reported except in the deceased animals. The LD50 of the testsubstance is > 2500 mg/kg bw.