ε-caprolactam

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1962

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

BASF-Test: The substance was injected into the peritoneal cavity. Young adult laboratory mice were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of 5 mice per sex and dose were treated simultaneously with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

ε-caprolactam

EC Number:

203-313-2

EC Name:

ε-caprolactam

Cas Number:

105-60-2

Molecular formula:

C6H11NO

IUPAC Name:

azepan-2-one

Test animals

Species:

mouse

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Mean body weight at study initiation:
200 mg/kg bw: male 24-28 g, female 21-25 g
400 mg/kg bw: male 21-23 g, female 21-23 g
500 mg/kg bw: male 21-26 g, female 19-25 g
640 mg/kg bw: male 21-27 g, female 19-24 g
800 mg/kg bw: male 21-25 g, female 17-24 g
1600 mg/kg bw: male 20-25 g, female 20-25 g

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

water

Details on exposure:

DOSAGE PREPARATION:
- Stock solutions prepared:
2 % for 200 mg/kg bw dose group,
8 % for 400, 500, 640 and 800 mg/kg bw dose groups, and
16 % for 1600 mg/kg bw dose group.

Doses:

200, 400, 500, 640, 800 and 1600 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: mortality and clinical signs of toxicity were observed several times on the application day and thereafter once each working day, body weights were only recorded at the beginning of the study.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

590 mg/kg bw

95% CL:

500 - 700

Mortality:

Mortality was observed (see table1).

Clinical signs:

Shortly after injection, apathy, tremor, tonic-clonic convulsions, dyspnoea and oral secreations were observed. In all surviving animals, symptoms were reversible 24 h later. In the 200 mg/kg bw group, apathy and accelerated respiration were observed after the injection.

Gross pathology:

no abnormalities were detected

Any other information on results incl. tables

Table 1: Mortality after 1h, 24h, 48 h and 7 days

Dose (ml/kg bw)	Mortality in
	1 h	24 h	48 h	7 days
1600	10/10	10/10	10/10	10/10
800	10/10	10/10	10/10	10/10
640	5/10	5/10	5/10	6/10
500	2/10	3/10	3/10	3/10
400	0/10	0/10	0/10	0/10
200	0/10	0/10	0/10	0/10

Applicant's summary and conclusion

Conclusions:

The LD50 value was found to be 590 mg/kg bw in male and female mice.

Executive summary:

In this study, the substance was injected into the peritoneal cavity. Young adult laboratory mice were purchased from breeder. Usually the source and strain of animals were not documented. Several groups of 5 mice per sex and dose were treated simultaneously with preparations of the test substance in suitable vehicle. The concentrations of these preparations were used to achieve comparable volumes per kg body weight. Group-wise documentation of clinical signs was performed over the 7 day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. Shortly after injection, apathy, tremor, tonic-clonic convulsions, dyspnoea and oral secreations were observed. In all surviving animals, symptoms were reversible 24 h later. In the 200 mg/kg bw group, apathy and accelerated respiration were observed after the injection. The LD50 value was found to be 590 mg/kg bw in males and females.