Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd. Biotechnology & Animal Breeding Division, Wölferstrasse 4, CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: Males 8 - 10 weeks. Females 10 - 12 weeks.
- Weight at study initiation: Males 198.4 - 246.5 g. Females 171.5 - 193.8 g.
- Housing: Individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22.5 - 23.5°C
- Humidity: 36 - 54 %
- Air changes: 10 - 15/hour
- Photoperiod: 12 hours light / 12 hours dark

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
One day before treatment, the backs of the animals were clipped with an electric clipper, exposing an area of approximately 10 % of the total body surface.

TEST MATERIAL
On test day 1, the test item was applied (as supplied) at a dose of 2000 mg/kg body weight evenly on the intact skin with a syringe and covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

Application volume/kg body weight: 1.72 ml (in relation to the density of the test item, 1.16g/cm2).

REMOVAL OF TEST SUBSTANCE
Twenty four hours after application the dressing was removed and the skin was flushed with lukewarm tap water and dried with disposable paper towels. Thereafter, the reaction sites were assessed.
Duration of exposure:
24 hours
Doses:
2000 mg/kg body weight
Application volume/kg body weight: 1.72 ml (in relation to the density of the test item, 1.16g/cm2).
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality - One, two, three and five hours after test itm application on test day 1
and twice daily during days 2 - 15.
Body weights - on test days 1, 8 and 15.
Clinical signs - Four times on test day 1, and once daily during days 2 - 15.
- Necropsy of survivors performed: Yes
Statistics:
The toxicity was estimated without the use of a statistical model.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured during the study.
Clinical signs:
No systemic or local signs of toxicity were observed during the study period.
Body weight:
The body weight of the animals was within the range comonly recorded for animlas of this strain and age.
Gross pathology:
No macroscopic finding were observed at necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
the median lethal dose for the acute dermal toxicity of CA 2814 B (Intermediate of CGA 276854) in rats of both sexes observed for a period of 14 days is estimated to be:
LD50 (rat): > 2000 mg/kg body weight.
Executive summary:

 

A group of five male and five female Hanlbm: WIST (SPF) rats was treated with CA 2814 B (Intermediate of CGA 276854) at 2000 mg/kg by dermal application. The test item was administered at a volume of 1.72 ml/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2 – 15. Mortality/viability was recorded once on test day 1 at separate observation time and then twice daily on test days 2 – 15. Body weight were recorded on day 1 prior to administration and on day 8 and 15. All animals were necropsied and examined macroscopically. 

 

No deaths occurred during study. 

 

No clinical signs were observed during the observation period. 

 

The body weight of the animals was within the range commonly recorded for animals of this strain and age. 

 

No macroscopic findings were observed t necropsy. 

 

Based on these observations, the median lethal dose for the acute dermal toxicity of CA 2814 B (Intermediate of CGA 276854) in rats of both sexes observed for a period of 14 days is estimated to be:

LD50(rat): > 2000 mg/kg body weight.