Fatty acids, C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated, lithium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP status not known, non-standard guideline, available as an unpublished report. Substance administered as a dilution in 1% carboxymethylcellulose. Only summary data available, limitations in design and/or reporting.

Justification for type of information:

See IUCLID section 13 for read across justification

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Lithium 12-hydroxystearate

EC Number:

231-536-5

EC Name:

Lithium 12-hydroxystearate

Cas Number:

7620-77-1

Molecular formula:

C18H36O3.Li

IUPAC Name:

lithium 12-hydroxyoctadecanoate

Test material form:

not specified

Details on test material:

No data reported.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

not specified

Details on test animals or test system and environmental conditions:

- Strain: OFA SPF rats originated from Sprague-Dawley
- Source: Bred at IFFA CREDO, Les Oncins, 69210 L'Arbresle
- Housing: 37.5 x 23.5 x 18 cm cages containing sterile sawdust bedding
- Acclimatisation: 1 day, treatment and breeding housing are identical
- Number of rats per cage: 5
- Feeding: Ad libitum with souriffarat and drinking water
- Pre-treatment preparation: Fasted for 15-20 hours prior to intubation
- Group weight per 5 animals: 167-168 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

16.66 % in hydrogel of CMC (1 %)

Details on oral exposure:

- Route of exposure: Oesophageal intubation

Doses:

- Dose: 5 g/kg bw
- Volume administered: 30 mL/kg
- Concentration: 16.66 %

No. of animals per sex per dose:

- Total number of animals: 10
- Number of animals per sex: 5 male, 5 female

Control animals:

no

Details on study design:

- Observations: First hours after intubation and for subsequent 14 days

Statistics:

No data reported

Results and discussion

Preliminary study:

No data reported

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 5 other: g/kg bw

Based on:

test mat.

Mortality:

- Mortality: No mortality was observed throughout the test

Clinical signs:

other: No data reported

Gross pathology:

No data reported

Other findings:

Safety testing in rats showed that lithium 12-hydroxystearate, administered orally to animals after 19 hours of fasting, can be considered as non-toxic, since it caused no toxicological manifestations at a dose of 5 g / kg bw under experimental conditions.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute toxicity of lithium 12-hydrosytearate applied to rats by oesophageal intubation gave an LD0 of 5 g/kg bw (LD50> 5 g/kg bw) and therefore is considered by the authors to be non-toxic.

Executive summary:

The acute toxicity of lithium 12-hydrosytearate administered to rats by oesophageal intubation gave an LD0 of 5 g/kg bw (LD50 > 5 mg/kg bw) and therefore is considered by the authors to be non-toxic. The acute oral toxicity of lithium 12 -hydroxystearate thickener was determined in a limit test. The test material was administered to rats as a hydrogel in 1% carboxymethylcellulose by oesophageal intubation and observations were made for the following 14 days. The data are taken from the summary report of an unpublished proprietary study (IFREB 1979).