Registration Dossier

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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
no clinical signs noted
Body weight:
The mean body weight gain shown over the study period was considered to be similar to the expected of normal untreated animals of the same age and strain.
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.