Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
Female rats: The clinical observations at the 3 hour observation period were recorded at 3 hours and 15 minutes after treatment. Body weight of all females were inadvertently not recorded on day 7 after treatment.
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class 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 7 - 11 weeks).
- Weight at study initiation: 178 - 190 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: Three same sex animals per cage.
- 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

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% (w/v) in 0.1 % (w/v) aqueous polysrbate 80.
Details on oral exposure:
- Dose level: 2000 mg/kg

- Vehicle: 0.5% (w/v) CMC (carboxy methyl cellulose) in 0.1% (w/v) aqueous polysrbate 80.

- Concentration: 3000.4 mg test item with vehicle ad 15 ml (males)
2000.6 mg test item with vehicle ad 10 ml (females)

- Volume applied: 10 ml/kg

- Rationale for the selection of the starting dose: The dose level of 2000 mg/kg for the limit test was selected based on the OECD/EEC
guidelines and pre-tests.
Doses:
One single dose by gavage.
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Period of observation: 14 days.

- Clinical observations: Checked and recorded individually at 1, 3 or 4 and 5 hours after dosing, then daily for the duration of the observation period.

- Mortality: Checked twice daily, morning and afternoon.

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

Results and discussion

Preliminary study:
The dose level of 2000 mg/kg for the limit test was selected ased on the OECD/EEC guidelines and pre-test results.
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.
Threrefore, the following acute oral 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 in-life observations indicating treatment-related systemic effects for any animal.
Body weight:
Body weights and body weight changes of animals were not affected by treatment.
Gross pathology:
Necropsy examinations revealed no observable abnormalities.

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 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 3 male and 3 female rats were administered a single dose of CA 2218 A (Intermediate CGA 276854), batch no. OP 802002, by gavage at a dose level of 2000 mg/kg, followed by a 14 day post-treatment observation period.  

There was no mortality in the study. 

There were no in-life observations indicating treatment-related systemic effects for any animal. 

Body weights were not affected by the treatment. 

Necropsy examinations revealed no observable abnormalities. 

The following acute oral 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