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 guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Initial weight of one female (102) was very slightly below the preferred range specified in the General Study Plan (200 - 300 g). This deviation has no impact on the integrity of the test.
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
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: 199.9 - 238.2 g
- Fasting period before study:
- Housing: Individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days

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

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 6cm x 6cm
- % coverage: 10%
- Type of wrap if used: Gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin cleaned with lukewarm water.
- Time after start of exposure: 24 hours.

TEST PROCEDURE
- Dose level: 2000 mg/kg.
- Ratio test item to vehicle: 8001.3 mg test item moistened with 8000 mg vehicle.
- Quantity applied: 400 mg per 100g body weight.


Duration of exposure:
24 hours
Doses:
1 single dose.
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
OBSERVATIONS AND RECORDS

Period of observation: 14 days after end of treatment.

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

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

Body weight: Measured and recorded immediately before dose administration, on days 7 and 14.

Results and discussion

Preliminary study:
The dose level of 2000 mg/kg for the limit test was selected based on the OECD/EEC guidelines and pre-test results.
Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male
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.
Threrefore, the following acute dermal LD50 values were determined for CA 2218 A (Intermediate 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

Clinical signs:
There were no clinical signs indicative of treatment-related effects for any animal.
Body weight:
A slight body weight was recoreded in two females (nos. 101 and 104) during the first week of treatment.
Gross pathology:
Necropsy examinations revealved no observable abnormalities.
Other findings:
There were no remarkable findings at the application site for any animal.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The following acute dermal LD50 values were determined for CA 2218 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 2218 A (Intermediate CGA 276854), batch no. OP 802002, by dermal application at a dose level 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 clinical signs indicative of treatment-related effects nor were there any remarkable findings at the application site for any animal. 

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

Necropsy examinations revealed no observable abnormalities. 

The following acute dermal LD50 values were determined for CA 2218 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