Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985-09-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to the 84/449/EEC acute oral toxicity test method under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): HF 0041
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: White Powder
- Physical state: Solid
- Analytical purity:
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: Lot # 480-1 F
- Expiration date of the lot/batch:
- Radiochemical purity (if radiolabelling):
- Specific activity (if radiolabelling):
- Locations of the label (if radiolabelling):
- Expiration date of radiochemical substance (if radiolabelling):
- Stability under test conditions:
- Storage condition of test material:
- Other: Lab received test material on 1985-09-05

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Iffa Credo (69210 St Germain sur l'Arbresle, France)
- Age at study initiation:
- Weight at study initiation: 126 g (male); 124 g (female)
- Fasting period before study: 1 day prior to treatment
- Housing: 5 animals/sex are housed in polycarbonate cages with stainless steel lids
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 7 days

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

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1% solution in water
Details on oral exposure:
VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle:
- Lot/batch no. (if required): Carboxymethyl cellulose (Lot # 58C-0156, Sigma); Water (Lot # 1195, Biosedra)
- Purity:

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 animals per sex
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Checked for mortality 2 times per day; Checked for clinical signs 1 time per day; Weighed prior to treatment and on days 5, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality recorded during the duration of the study
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality recorded during the duration of the study
Mortality:
No mortality was recorded during the duration of the study.
Clinical signs:
No symptoms were noted during the observation period.
Body weight:
No significant, treatment-related body weight changes were observed during the duration of the study.
Gross pathology:
No abnormalities were detected upon gross examination of the principal organs of animals euthanized at the end of study. Due to the lack of damage at the macroscopic examination, no samples were performed for histological examination.

Applicant's summary and conclusion

Conclusions:
Under the conditions of this study, the acute oral LD50 of the test substance is >5000 mg/kg.