Vinyl laurate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-11-07 to 1991-02-27

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD test under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Vinyllaurat

IUPAC Name:

Vinyllaurat

Details on test material:

- Name of test material (as cited in study report): Vinyllaurat
- Physical state: colourless liquid
- Impurities (identity and concentrations): as stated in substance data
- Composition of test material, percentage of components: as stated in substance data
- Lot/batch No.: 959837
- Stability under test conditions: stable

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Interfauna Süddeutsche Versuchstierfarm, Tuttlingen; Germany
- Age at study initiation: not mentioned
- Weight at study initiation: males 224 - 238 g; females 220 - 234 g
- Fasting period before study: 24 hours
- Housing: standard laboratory conditions; each animal in a separate Makrolon cage
- Diet: alma 0801 H 1003; two times a day each 8 g
- Water: ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 1 °C
- Humidity (%): 45 - 70
- Air changes (per hr): not mentioned in the report
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

not used

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male/5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at periodic intervals on the day 1 and once daily during day 2-15 examination for clinical signs/mortality; body weights were recorded on every day
- Necropsy of survivors performed: yes
- Examinations performed: clinical signs, mortality, body weights, food consumption, behaviaour; necropsy

Statistics:

not possible, limit test

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No animal died during the test and the subsequent observation period

Clinical signs:

other: no clinical signs noted

Gross pathology:

no abnormalities noted

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 (oral, rat) was determined to be > 2000 mg/kg bw.

Executive summary:

A group of five male and five female Sprague-Dawley rats was treated with Vinyl laurate at 2000 mg/kg by oral gavage according to OECD Guideline 401 with a 14 days observation period. No animal died during the study. No signs of toxicity were not observed in any animal. The body weight of the animals was within the range of physiological variability known for rats of this strain and age. No macroscopic findings were observed at necropsy of the animals. The LD50 (oral, rat) was determined to be > 2000 mg/kg bw.