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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Version / remarks:
Cited as Directive 84/449/EEC, B.1
GLP compliance:
yes
Remarks:
(Bayer AG, Institute of Toxicology)
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): epsilon-Caprolactam
- Physical state: solid
- Analytical purity: 99.9%
- Lot/batch No.: Charge No. 1272
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: male 9 weeks, female 14 weeks
- Mean weight at study initiation: male 182 g, female 170 g
- Fasting period before study: 16 h before dosing
- Housing: 5 per cage
- Diet (e.g. ad libitum): Altromin 1324 pellets
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2
- Humidity (%): 50±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 ml/kg bw

Doses:
male: 0, 312, 1000, 1250, 1600, 2000, 2250 mg/kg bw
female: 0, 312, 1000, 1250, 1600, 2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: several times on the day of application and daily thereafter. Body weights were recorded before application, 7 d post application and at the end of the observation period.
- Necropsy of survivors performed: yes
Statistics:
Rosiello et al., J. Tox. Environ. Health 3, 797, 1977.

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
1 475 mg/kg bw
95% CL:
1 216 - 1 789
Sex:
male
Dose descriptor:
LD50
Effect level:
1 876 mg/kg bw
95% CL:
1 359 - 2 590
Mortality:
see free text
Clinical signs:
1250 - 2250 mg/kg bw: clonic convulsion, piloerection, salivation, dyspnoea, tremor, high stepping gait, nose discharge, hollow flanks. The signs were observed till 7 days of the observation period. In the females of 1000 mg/kg bw dose group, slight gasping was observed.
Body weight:
There was no effects on the body weight gain in all dose groups.
Gross pathology:
Deceased animals: redness in the lungs and gastro-intestinal tract, enlarged liver
Sacrificed animals: no abnormalities were detected

Any other information on results incl. tables

Male

Dose (mg/kg bw)

Mortality rate

Died within

312

0/5

-

1000

0/5

-

1250

0/5

-

1600

3/5

6 h

2000

2/5

4 h

2250

4/5

5 h

Female

Dose (mg/kg bw)

Mortality rate

Died within

312

0/5

-

1000

1/5

3 h

1250

0/5

-

1600

4/5

6 h

2000

4/5

4 h

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU