Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2000-02-01 into 2000-02-15
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: EC 92/69/EEC, B.3 Acute toxicity cutaneously OECD 402
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test batch: No.: 7/99

Test animals

Species:
other: rat- Wistar
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Wistar
- Housing: cage per 5 animals by sex
- Diet (e.g. ad libitum): standard food ST-1, ad libidum
- Water (e.g. ad libitum): ad libidum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: The sample was applied in delivered form "as is" tempered at 20-C.
Details on dermal exposure:
TEST SITE
-Area: 6x6 cm
- Type of wrap if used: gauze, foil

REMOVAL OF TEST SUBSTANCE
- Washing (if done): by water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):2 ml/kg
- Concentration (if solution): direct sample
Duration of exposure:
24 h
Doses:
2037 kg/kg
No. of animals per sex per dose:
Male dose: 2037 mg/kg bw Nr. of animals. 5 Nr. of deaths 0
Female 2037 mf/kg bw 5 0
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
95% CL:
95
Mortality:
Male: 2037 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2037 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: During 14 days observantion period the percentage of the mortality was accounted. Futher the body weight was found out at the beginning and at the end of the experiment and from the difference the increase and the loss were calculated. The clinical symptoms of intoxication were observed next the application, in 30 minutes, in 3 hours, next morning and in the afternoon and further days once a day for 14 days. The clinical diagnistic was concentratedon the observation of skin appearance, fell, visible mucouses, nutrition state, mental and motor activity, reaction to the impulses and the examination of the function of aspirative,digestive, urogenital and circulatory apparatus. All the animals survived the testing period without any symptoms of intoxication.
Body weight:
The animals were weighted in 1., 8., and 15. day.
On the base of body weight of rats at the beginning and at the end of test, weight increase or decrease was calculated.


Gross pathology:
Effects on organs:
After 14 days the surviving animals were killed and
disemboweled, their apparatuses and their muscles were
macroscopicly considered. Their size, colour, shape,
structure and consistency were considered.

No toxic effect on the organs were found after sacrifice on
day 15.
Other findings:
Signs of toxicity (local):
The light local effects of the substance were fully lost at

the end of the test.

Any other information on results incl. tables

Table of body weight:

 Dose 2 ml/kg  Nr. of animals   

 body weight in g 1 day (mean)

  

 body weight in g 8. day (mean)

         body weight in g 15. day (mean)

 weight difference (g)
 Male  5  233 +/-11,6 285,6 +/-20 331,5 +/-27,8  + 98,4
 Female  5  217,8 +/-10 239,4 +/-15  261,2 +/-17,2   +43,4

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU