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:
1999
Report Date:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

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. 4414 Füllinsdorf / Switzerland
- Age at study initiation: Young adult (approximately 8 - 12 weeks)
- Weight at study initiation: 212 - 271 g
- Housing: Individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 % ± 20 %
- Air changes (per hr): 13 - 14/hour
- Photoperiod (hrs dark / hrs light): 12/12 hours

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 6 cm x 6 cm
- % coverage: 10 %
- Type of wrap if used: Test item applied evenly to whole shaved area by means of a gauze-lined semiocclusive dressing fastened
around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned with lukewarm water.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 200 mg per 100 g body weight.
- Concentration: 100 % (undiluted)
Duration of exposure:
24 hours
Doses:
Single dose
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Period of observation: 14 days

- Clinical observations: Checked and recorded individually within the first two hours then daily for the duration of the
observation period.

- Local tolerance: The application site was examined daily for signs of dermal irritation. Any deviations from normal were
recorded using the Draize scale

- Mortality: Checked twice daily, morning and afternoon.

- Body weight: Measured and recorded Immediately before dose administration.

- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There was no mortality in the study.
Clinical signs:
There were no remarkable clinical observations for any animal.
Body weight:
A slight loss of body weight was recorded in one female (no. 104) during the first week after treatment.
Gross pathology:
Necropsy examinations revealed no observable abnormalities.
Other findings:
- Local tolerance: There were no remarkable findings at the application site.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The following acute oral LD50 values were determined for CA 2219 A Intermediate of CGA 276854):

LD50 in male rats: Greater than 2000 mg/kg body weight
LD50 in female rats: Greater than 2000 mg/kg body weight
LD50 in rats of both sexes: Greater than 2000 mg/kg body weight
Executive summary:

 

Groups of 5 male and 5 female rats were administered a single dose of CA 2219 A (Intermediate CGA 276854) (batch no. 249-GE001/SU) by dermal application at a dose levels of 2000 mg/kg for 24 hours under semiocclusive conditions, followed by a 14 day post-treatment observation period.  

There was no mortality in the study. 

There were no remarkable clinical observations nor were there any remarkable findings at the application site for any animal. 

A slight loss of body weight was recorded in one female during the first week after treatment. 

Body weights were not affected by the treatment. 

Necropsy examinations revealed no observable abnormalities. 

 

The following acute oral LD50 values were determined for CA 2219 A Intermediate of CGA 276854):

 

LD50in male rats:                               Greater than 2000 mg/kg body weight

LD50in female rats:                            Greater than 2000 mg/kg body weight

LD50in rats of both sexes:                 Greater than 2000 mg/kg body weight