Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct 28 - Nov 12, 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed in compliance with the Good Laboratory Practice (GLP) regulations. The method followed that described in the OECD Guidelines for Testing of Chemicals (Adopted: 4 April 1984) No 423 "Acute Oral Toxicity – Acute Toxic Class Method".

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

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
Principles of method if other than guideline:
None
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 system
Species: Rat, Wistar HsdCpb: WU, males (m) and females (f)
Breeder: F. Winkelmann, 33178 Borchen
Age: approx. 6 to 9 weeks

- Identification and adaptation
Healthy young animals were allocated to the study group at least 7 days before dosing to allow for acclimatization.
The rats were identified by an ear tattoo.

- Housing and diet
The rats were housed in an air-conditioned room of about 25 m^2. Lighting was controlled by a timer to provide a 12 hour light - 12 hour dark regime.

The rats were kept separately in type III Makrolon cages with a shelter, placed on mobile racks. Conventional softwood granulate was used
as the bedding. One day before treatment, and up to 24 hours after dosing, metal grids were placed above the softwood granulate.
The cages and the metal grids had been machine-cleaned before the start of the experimental part. The bedding was changed two times per
week.

Temperature and humidity were measured using a thermohygrograph. The room temperature during the experimental period was 20 to 24 °C
and the relative atmospheric humidity 50 to 68 %.

Diet was withheld from 17 hours before until up to 4 hours after treatment. At all other times food and tap water from Makrolon drinking
bottles were available to the rats ad libitum.

The diet (Altromin Standard Dist TPF 1324) is checked by independent laboratories by an independent laboratory. Analysis included qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics.
The drinking water was periodically analyzed according to the regulations for human drinking water.

The softwood granulate was analytically checked by independent laboratories.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Methocel K4M Premium
Details on oral exposure:
The rats received the test material preparations orally by means of a stomach tube.
Doses:
The test material concentration was 100 g/L.
The dose was 20 mL/kg or 2000 mg/kg bw.
No. of animals per sex per dose:
3 (m) / 3 (f)
Control animals:
no
Details on study design:
-- Observation for clinical symptoms
The behavior and general condition of all rats were monitored for at least 6 hours after the administration and then checked daily.

-- Body weight
All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.

-- Pathology
All rats were sacrificed at the end of the experimental part by C02-asphyxia and subjected to gross pathological investigations.

-- Archive statement
All raw data, specimens, and the final report are stored in the archives of the testing facility.
Statistics:
The body weight data were recorded with the PC-program ,,AKUDAT". The statistical evaluations of the body weight were carried out with PC. The body weight development of each rat and group was determined. The group mean value was calculated for each measurement and printed on tables.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000
Mortality:
No mortality observed. All rats survived the observation period.
Clinical signs:
No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg of CCP-V2-1.
Body weight:
Body weight development of the treated rats was inconspicuous.
Gross pathology:
At necropsy no organ alterations were seen.
Other findings:
None

Any other information on results incl. tables

No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg bw of CCP-V2-1.

All rats survived the observation period. Body weight development of the treated rats was inconspicuous. At necropsy no organ alterations were seen.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the results of this study the test material can be allocated to ATC class 0 i.e. the LD50 value is expected to exceed 2000 mg/kg.
Executive summary:

Purpose

The purpose of this acute toxicity study was to provide information on possible health hazards in case of acute oral contact with a test material and serve as a a rational basis for risk assessment to the acute toxicity potential of the test item in man.

Study design

The test material CCP-V2-1 was tested for acute toxicity in rats after oral administration of 2000 mg/kg body weight. Directly before the administration the test material was prepared with aqueous Methocel K4M Premium solution as vehicle.

This study was performed according to the ,,Acute toxic class method" (ATC).

Results

No signs of toxicity were detected in the 3 male and 3 female rats after treatment and no rat died.

The gross pathological examination revealed no organ alterations.

Conclusions

According to the results of this study the test material can be allocated to ATC class 0 i.e. the LD50 value is expected to exceed 2000 mg/kg.