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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: Acceptable, well documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
(only one test concentration)
GLP compliance:
no
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): 1-Ethylpiperidin
- Physical state: liquid
- Analytical purity: > 98 %

Test animals

Species:
rabbit
Strain:
Vienna White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: M. GAUKLER, Offenbach; Germany
- Mean weight at study initiation: males: 2.4 kg; females: 2.5 kg
- Diet: Ssniff K, Standard diet for rabbits and guinea pigs, INTERMAST GmbH, Soest, Germany, ad libitum
- Water: water, ad libitum

ENVIRONMENTAL CONDITIONS
- no data


Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: the clipped skin of the back and flanks; clipping of the dorsal and lateral parts of the trunk was performed ca 15 to 24 hours before treatment.
- Application area: approx. 50 cm²
- Type of wrap if used: inert foil, fixed with a adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with warm water or a water:lutrol mixture and dried with cellulose
- Time after start of exposure: 24 hrs

Duration of exposure:
24 h
Doses:
200 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 8 days
- Frequency of observations and weighing: Check for dead or moribund animals was performed within 1, 24 and 48 hours and within 8 days. Clinical signs of intoxication were recorded on working days.
- Necropsy of survivors performed: yes, animals were sacrificed with CO2
- Other examinations performed: clinical signs, local irritating skin findings

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality (0/10 animals died).
Mortality:
0/5 males and 0/5 females died.
Clinical signs:
No systemic toxicity observed.
24 hours after application all animals showed irritation and formation of necrosis, not reversible at the end of the observation period.
Gross pathology:
Sacrificed animals: no substance-related findings.

Applicant's summary and conclusion