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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions (occlusive dressing instead of semi-occlusive)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: 84/449/EWG (Official Journal of EU, Nr. L251 from 19.09.1984, p 103)
Deviations:
yes
Remarks:
occlusive dressing instead of semi-occlusive
GLP compliance:
yes
Remarks:
(Bayer AG, Institute of Toxicology)
Test type:
standard acute method
Limit test:
yes

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%
- 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 230 g, female 211 g
- 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

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- % coverage: 10%
- Type of wrap if used: The treated area was covered and fixed with aluminum foil


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 24 h


TEST MATERIAL
- 3ml/kg bw test substance was applied
Duration of exposure:
24 h
Doses:
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: Body weight of individual animals was measured before treatment and after 7 and 14 days of treatment, daily clinical inspection
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no mortalities were observed
Clinical signs:
no clinical signs were observed
Body weight:
Delayed weight gain in some animals.
Gross pathology:
no abnormalities were observed

Applicant's summary and conclusion