Vinyl neononanoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the O.E.C.D. 402 Testing Guideline with GLP compliance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

As per IUCLID5 Sections !.1. - 1.4.

Specific details on test material used for the study:

One container of approximately 5 litres (approximate gross weight 4646 g) of the test material, VeoVa 9, Batch No. C000700086, was received at lnveresk on 21 November 1997. The test material, a colourless liquid, was stored in the dark at 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 five female (nulliparous and non-pregnant) young adult rats of the Sprague-Dawley strain were used. They were 4 weeks old and weighed 54-83 g on arrival. They were supplied by Charles River UK, Margate, Kent. The animals were housed individually in suspended polypropylene cages (dimensions 42 x 27 x 20 cm), with stainless steel grid tops and bottoms, suspended over absorbent paper lined trays. Mean environmental maximum and minimum temperatures were 21°C and 18°C and mean relative humidity was 48%. A 12 h lightldark cycle was in operation (light hours 0700-1900 h) with 15-20 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. Domestic mains quality drinking water was available ad libitum throughout the study. The animals were allowed to acdilmatise for at least 5 days prior to commencement of the study.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

One day prior to test material application the dorsal area of the trunk of each rat was clipped free of hair (4 cm x 6 cm), taking care to avoid abrading the skin. On the following day, the appropriate quantity of test material was applied, which was calculated to be 39 mg.cm2, onto the dorsal skin and spread uniformly over the trunk (approximately 10% of the total body surface). The test material was then covered by a gauze patch (2.5 cm x 5 cm). The patch was then secured with MicroporeTM (3M Medical-Surgical Division, USA) semi-occlusive tape, and a strip of non-irritating occlusive tape (Sleek, Smith and Nephew Medical Limited, USA) wound round the trunk. The applied dose was calculated based on the weight of the animal on the day of dosing, and the dose volume accounted for the specific gravity of the test material.

Duration of exposure:

24 hours

Doses:

2 g/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

The test material vinyl neononanoate was administered dermally in a single 24 h application, under occlusion. After a contact period of 24 h the patches were removed and the skin wiped with water. All the animals were checked for viability early in the morning and again as late as possible on each day. Clinical observations were conducted frequently (at least 4 timepoints) on the day of dosing and daily thereafter until sacrifice on Day 15. The body weight of each animal was recorded on the day of dosing (Day 1), Days 8 and 15. Each animal was subjected to necropsy following sacrifice by carbon dioxide asphyxiation on Day 15. The necropsy consisted of an examination of the thoracic and abdominal organs and tissues in situ.

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

None

Clinical signs:

other: No significant signs

Gross pathology:

No abnormal findings.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

The acute rat dermal LD50 value for vinyl neononanoate was > 2000 mg/Kg (The Limit Dose) suggesting little or no acute dermal toxicity.

Executive summary:

Vinyl neononanoate was assessed for acute dermal toxicty in the rat following an O.E.C.D. 402 Testing Guideline and the GLP regulations. No mortalities or adverse clincial signs were observed during the study. The acute rat dermal LD50 value for vinyl neononanoate was > 2000 mg/Kg (The Limit Dose) suggesting little or no acute dermal toxicity.