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:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method

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: BRL Biological Research Laboratories, Wölferstrasse 4, 4414 Füllinsdorf / Switzerland
- Age at study initiation: Young adult (approximately 7 - 11 weeks).
- Weight at study initiation: 172 - 230 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 % aqeuous polysorbate 80
Details on oral exposure:
- Dose level: 200 mg/kg (females), 2000 mg/kg (both sexes)

- Number of animals per dose level: 3 males and 3 females (2000 mg/kg)
3 females (200 mg/kg)

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

- Concentration: 200 mg/kg: 201 mg test item with vehicle ad 10 ml
2000 mg/kg: 2025 mg test item with vehicle ad 10 ml
2000 mg/kg: 1993 mg test item with vehicle ad 10 ml

- Volume applied: 10 ml/kg

- Rationale for the selection of the starting dose: The dose level was selected based on EU classification criteria and pre-test results.
Doses:
One single dose
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 was selected based on EU classification criteria 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 2219 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 the 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 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 3 male and 3 female rats were administered a single dose of CA 2219 A (Intermediate CGA 276854) (batch no. 249-GE001/SU) by gavage at a dose levels of 200 mg/kg (females) and 2000 mg/kg (both sexes), 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 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