Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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:
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 and ocular discharge, emaciation, food consumption decrease, prostration, breathing abnormalities, and staining of the fur. All surviving animals were free of abnormalities from Day 6 through study termination,
Body weight:
All surviving animals exhibited weight gain relative to their prefast values at termination.
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

Applicant's summary and conclusion