Vinyl neononanoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was conducted according to an O.E.C.D. Tesing Guideline under the GLP regulations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes (incl. QA statement)

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

As per IUCLID5 Sections 1.1. - 1.4.

Specific details on test material used for the study:

One container of approximately 5 litres (approximate gross weight 4646g) of the test material, VeoVa 9, Batch No. C000700086, was received at Inveresk on 21 November
1997. The test material, a colourless liquid, was stored in the dark at an ambient temperature.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Five male and 5 female (nulliparous and non-pregnant) young adult rats of the Sprague-Dawley strain were used. They were 5-7 weeks old and weighed 178-232 grams on arrival. They were supplied by Charles River UK, Margate, Kent. The animals were allowed to acclimatise for at least 5 days prior to commencement of the study. The animals were housed multiply by sex in suspended polypropylene cages (dimensions 59 x 38.5 x 20 cm) with stainless steel grid tops and bottoms. Beneath each cage was a suspended tray lined with absorbent paper. Each cage was supplied with a water bottle and metal food hopper. Mean environmental maximum and minimum temperatures were 21°C and 19°C and mean relative humidity was 48%. A 12 h light/dark cycle was in operation (light hours 0700-1900 h) with I 5-20 air changes per hour. Rat and Mouse No. I Maintenance Diet, supplied by Special Diets Services Limited, I Stepfield, Witham, Essex, CM8 3AD was available ad libitum throughout the study except for a period of food deprivation overnight prior to dosing. Domestic mains quality water was available ad libitum throughout the study.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test material was administered orally in a single dose by means of a gavage. The dose was calculated based on the weight of the animal on the day of dosing and accounted for the specific gravity of the test material.

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Following oral gavage dosing all the animals were checked for viability early in the morning and again as late as possible on each day. All the animals were examined for reaction to treatment. The onset, intensity and duration of any signs were recorded. Clinical observations were conducted frequently on the day of dosing and daily thereafter until sacrifice on Day 15. The body weight of each individual animal was recorded on the day of dosing (Day 1), Days 8 and 15. Following sacrifice the necropsy consisted of an examination of the thoracic and abdominal organs and tissues in situ. Carcasses were discarded following this procedure.

Statistics:

None conducted

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

none

Clinical signs:

other: Clinical signs noted up to Day 3 (primarily on Day 2), included subdued behaviour, staggering, laboured breathing, piloerection, hunched appearance and a watery discharge from the eyes and or nose.

Gross pathology:

No abnormalities were detected at necropsy.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The acute oral LD50 value for vinyl neononanoate is > 2000 mg/L the Limit dose.

Executive summary:

This study conducted according to an O.E.C.D. Testing Guideline and the GLP regulations investigated the acute oral toxicity of vinyl neononanoate after a single oral gavage administration to Sprague Dawley rats. One group of 5 male and 5 female rats received 2000 mg/kg the Limit Dose. There was no mortality during study. Body weight gain was normal. No abnormalities were detected at necropsy.

Under the conditions of the study, the LD50 value of vinyl neononanoate was estimated to be greater than 2000 mg/kg in the rat.