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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 16 CFR 1500

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:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Cedar Knoll
- Age at study initiation: not indicated
- Weight at study initiation: males; 2.34-2.96 kg; females; 2.30-2.73 kg
- Housing: individually
- Diet: Fisher Rabbit Pellets ad libitum
- Water: ad libitum
- Acclimation period: 37 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): not indicated
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 4-5 cm2 ( in 3 males and 2 females abrasions were made on 5-6 cm2)
- Type of wrap if used: non-permeable patch secured with tape and elastic sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

TEST MATERIAL
- Amount(s) applied : 2mL
- Concentration (if solution): 50%

Duration of exposure:

24 hours

Doses:

2 mL/kg

No. of animals per sex per dose:

5 males + 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated; weight at start and end of the study
- 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 mL/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 1 000 mg/kg bw

Based on:

act. ingr.

Mortality:

1 female (skin abraded) died on day 1

Clinical signs:

none reported

Body weight:

weight loss in the female that died; other animals as expected

Gross pathology:

In the female that died: distension of stomach and gastrointestinal tract; disoloration of liver/kidney/heart
Other animals: no findings

Applicant's summary and conclusion

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test substance is > 1000 mg/kg bw.

Executive summary:

Five rabbits/sex were treated dermally with 1000 mg/kg bw of the test substance for 24 hours. One female died on day 1. All other animals appeared healthy until the end of the 14 day observation period. Therefore it is concluded that the test substance is of minor toxicity with an LD50 > 1000 mg/kg bw.