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Toxicological information

Acute Toxicity: other routes

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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:
other: Acceptable well documented study report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1962

Materials and methods

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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Caprolactam

Test animals

Species:
mouse
Strain:
not specified
Sex:
male/female
Details on test animals 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:
see free text
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

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