Fatty acids, C16-18, sodium salts

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Edenor C16 98 - 100, palmitic acid

IUPAC Name:

Edenor C16 98 - 100, palmitic acid

Constituent 2

Reference substance name:

[TN]Fatty acid C 16-18, sodium salt[/TN][SPEC][/SPEC][AM][/AM]

IUPAC Name:

[TN]Fatty acid C 16-18, sodium salt[/TN][SPEC][/SPEC][AM][/AM]

Details on test material:

no data

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: mean body weight female rats: 137g; mean body weight male rats: 183g
- Fasting period before study: 18 hours
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 45-60%
- Photoperiod: 12 hrs dark /12 hrs light

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

- Concentration in vehicle: 50%

Doses:

5g test substance/kg body weight

No. of animals per sex per dose:

5 animals per sex and dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: immediately after application, 1, 4 and 24 hours after application, daily thereafter
- Frequency of weighing: immediately before application, 1, 7 and 14 days after application
- Necropsy of survivors performed: yes

Statistics:

no data

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

One female rat died on day 12.

Clinical signs:

other: 20 minutes after treatment, the symptomes of poisoning were strongly ruffled fur and slightly decreased activity. This symptoms subsided completely within 24 hours.

Gross pathology:

Apart from a swelling of the gastric mucosa in male and female rats, there were no signs of poisoning.

Any other information on results incl. tables

Mean body weight

Dose	Gender	Before application	24 hours after application	7 days	14 days
5 g/kg	male	183.0	195.0	214.0	234.0
5 g/kg	female	137.0	143.0	149.0	160.0

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The LD50 of Edenor C 16 98-100 is estimated to be higher than 5000 mg/kg body weight in male and female rats for a single dose.
Therefore the test substance Edenor C 16 98-100 is practically nontoxic according to the OECD Guideline 401.

Executive summary:

Aim of the study

It was the aim of the study to investigate acute toxic effects of the test substance after a single oral administration.

Methods

The OECD-Guideline 401, "Acute Oral Toxicity" was applied.

Administration

Edenor C 16 98-100 was administered once oral by stomach intubation to Wistar rats. The dosing was performed sequentially to 5 male and 5 female animals, each using a dose of 5000 mg per kg body weight.

Investigations

Body weight: before administration, 1, 7 and 14 days p.a.

Clinical observations were performed 0, 1, 4, 24 hours p.a. of the test substance and then at least once a day for a total of 2 weeks.

Necropsy: all animals were sacrificed and necropsied 14 days p.a.

Results

Mortality

One female rat died on day 12.

Body weights

Males and females: Body weight and body weight gain of all animals were inconspicuous.

Clinical observations

20 minutes p.a. all animals indicated symptoms of poisoning. All animals showed strongly ruffled fur and slightly decreased activit

Necropsy findings

Apart from a swelling of the gastric mucosa in male and female rats, there were no signs of poisoning

Sex differences

The response to the test substance at 5000 mg/kg body weight did not indicate a sex difference.

The LD50 of Edenor C 16 98-100 is estimated to be higher than 5000 mg/kg body weight in male and female rats for a single dose. Therefore the test substance Edenor C 16 98-100 is practically nontoxic according to the OECD Guideline 401.