Lithium (C8-C10, branched, C9 rich, alkylnaphthalene sulphonate)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: limited report, non-GLP. 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

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lithium (di C8-C10, branched, C9 rich, alkylnaphtalene sulphonate)

IUPAC Name:

Lithium (di C8-C10, branched, C9 rich, alkylnaphtalene sulphonate)

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 Farm
- Age at study initiation: not indicated
- Weight at study initiation: males: 252-281 g ; females: 224-264 g
- Fasting period before study: 18 hours
- Housing: individually
- Diet: Fisher Rat Chow ad libitum
- Water: ad libitum
- Acclimation period: 17 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: oil (not further specified)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50%

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

5 mL/kg bw

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 (study seems to have been stopped after 7 days based on date of initiation and report date)
- Frequency of observations and weighing: not indicated; weighing at start and end of the study period
- 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:

> 5 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 500 mg/kg bw

Based on:

act. ingr.

Mortality:

2 females died on day 2; 1 female on day 5

Clinical signs:

diarrhea 2 hours after dosing in all animals
nasal bleeding in females that died

Body weight:

males: within normal ranges
females: decreased weight gain in females that died

Gross pathology:

Females that died: Pulmonary Hemorrhage (all), Intestinal Hemorrhage (all), Discolored, kidney (2/3), necrosis of Spleen (2/3), necrosis of Liver (2/3)

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the outcome of this test, the LD50 is > 2500 mg/kg bw

Executive summary:

In a limit test 5 rats/sex received 2500 mg/kg bw of the test substance by gavage. 3 females died with severe nasal bleedings before day 5. Macroscopic examination revealed pulmonary hemorrhage, intestinal hemorrhage, discolored kidney, necrosis of spleen and necrosis of liver in these animals. In addition bodyweight (gain) was decreased. Other animals appeared normal during the observation period. The LD50 is > 2500 mg/kg bw.