1-vinylhexahydro-2H-azepin-2-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No guideline outlined in study that has been applied, but procedure was similar to OECD401; well described record

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Report date:

1994

Materials and methods

Test guideline

Qualifier:

equivalent or similar 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:

1-vinylhexahydro-2H-azepin-2-one

EC Number:

218-787-6

EC Name:

1-vinylhexahydro-2H-azepin-2-one

Cas Number:

2235-00-9

Molecular formula:

C8H13NO

IUPAC Name:

1-vinylazepan-2-one

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Vinyl Caprolactam
- Physical state: White Crystals
- Analytical purity: asssumed to be 100% pure
- Lot/batch No.: 30114
- Expiration date of the lot/batch: January 20, 1994
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

other: CDBR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: males: 8-9 wekkes, females 10-11 weeks
- Weight at study initiation: Males: 195 - 302 grams; Females: 188 - 223 grams
- Fasting period before study: yes (overnight)
- Housing: Single housed during the test period.
- Diet (e.g. ad libitum): Certified Rodent Checkers #5002 (mash), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68-76° F
- Humidity (%): 40-70% relative humidity
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test material was heated in a water bath at 46° Celsius (group 1) and 47° Celsius (groups 2 and 3) untilliquified.
The undiluted test material was administered by a single oral intubation via syringe and a stainless steel, straight, ball tipped feeding needle.
Individual animal doses were calculated by dividing the specified dose level by the density (1.02 g/ml) to arrive at the dose volume. The dose volume was then multiplied by the animal's fasted body weight to arrive at the dose.

Doses:

0, 600, 1300, 2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Animals were examined for viability twice daily for two weeks.
Body weights were recorded the day prior to dosing (pretest), on the day of dosing (Day 0), on Days 7 and 14, and at death for animals succumbing prior to termination.
After the Day 14 observations, all surviving animals were sacrificed and analyzed by gross necroscopy.

Statistics:

The oral median lethal dose (LD50) was calculated using the standard Litchfield Wilcoxon technique (Litchfield and Wilcoxon, 1949) with equal weighting of the data values.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 114 mg/kg bw

Based on:

test mat.

95% CL:

> 877 - < 1 416

Mortality:

1/10 at 600, 6/10 at 1300 and 9 at 2000 mg/kg (see table below)
All mortalities occurred prior to Day 3, with the majority at day 0

Clinical signs:

other: Adverse clinical effects were observed in all groups primarily from Day 0 to Day 4. Abnormal clinical signs noted during the study included hypoactivity, hyperactivity, hypothermia, aggressive behavior, ataxia, abnormal production of stool, oral, nasal an

Gross pathology:

Postmortem examination of those animals found dead revealed lung discoloration and tissue consolidation, staining of the fur, liver discoloration, nasal and/or oral discharge. Abnormal content of the stomach and small intestine were also noted. These abnormal contents appeared to be test material. No abnormalities were observed in any animal surviving to termination.

Any other information on results incl. tables

	Male	Female	Combined
600	1	0	1
1300	2	4	6
2000	4	5	9
LD50	1236	1049	1114