Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1956 December
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1956
Report Date:
1956

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
- Principle of test: The toxicity of test substance has been studied using rats in acute and subacute oral studies, guinea pigs in the skin irritation and sensitization tests. A limited patch tet has been run with eighteen human subjects.
- Short description of test conditions: The samples used in this study were test sample, cotton sheeting impegrnated with 0.5 percent test substance, cotton sheeting impregnated with 0.75 percent test substance and cotton sheeting control.
The cotton sheeting samples were prepared by treating with an aquaeous solution of the test substance. The product was dissolved in distilled water and applied to the cotton sheeting by padding. The cloth samples were then air dried and ironed. The cotton sheeting control was put through the same procedure, omitting the test substance.
- Parameters analysed / observed: clinical and pathological signs have been observed
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: TLF-945-B
- Expiration date of the lot/batch: not specified
- Purity test date: not specified

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: low solubility
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not observed

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The samples used in this study were test sample, cotton sheeting impegrnated with 0.5 percent test substance, cotton sheeting impregnated with 0.75 percent test substance and cotton sheeting control.
The cotton sheeting samples were prepared by treating with an aquaeous solution of the test substance. The product was dissolved in distilled water and applied to the cotton sheeting by padding. The cloth samples were then air dried and ironed. The cotton sheeting control was put through the same procedure, omitting the test substance.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not specified
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Fasting period before study: not specified
- Housing: not specified
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 16 hours light and 8 hours dark

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100, 0.75 and 0.5
- Amount of vehicle (if gavage): not specified
- Justification for choice of vehicle: not specified

Maximum dose applied: 25000 mg/kg

DOSAGE PREPARATION (if unusual): The samples used in this study were test sample, cotton sheeting impegrnated with 0.5 percent test substance, cotton sheeting impregnated with 0.75 percent test substance and cotton sheeting control.
The cotton sheeting samples were prepared by treating with an aquaeous solution of the test substance. The product was dissolved in distilled water and applied to the cotton sheeting by padding. The cloth samples were then air dried and ironed. The cotton sheeting control was put through the same procedure, omitting the test substance.

- Rationale for the selection of the starting dose: not specified
Doses:
the two highest dose levels are 17000 mg/kg and 25000 mg/kg.
No. of animals per sex per dose:
not specfied
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 9-13 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD100
Effect level:
> 25 000 mg/kg bw
Based on:
test mat.
Mortality:
not observed
Clinical signs:
slight diarrhea at the second highest dose and severe dirrhea at the highest dose
Body weight:
not specified
Gross pathology:
no pathological changes were noted
Other findings:
- Organ weights: not specififed
- Histopathology: no pathological changes were noted
- Potential target organs: not specified
- Other observations: no other observations

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Tests of acute and subacute oral toxicity showed that the substance is of a very low order of oral toxicity hence the GHS criteria for classification has not been met.
Executive summary:

By stomach tube administration to the albino rats, the approximate lethal dose of test item was found to be greater than 25 000 mg/kg bw. The only clinical signs observed were severe diarrhea at the highest level tested and slight diarrhea at the next level, 17 000 mg/kg bw. No pathological changes were noted when the animals were sacrified 9 to 13 days after treatment.