Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16.4-30.4.2002
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Humic acids and fulvic acids extracted from leonardite, reaction product with formaldehyde, potassium hydrogen sulfite, sodium hydrogen sulfite and potassium hydroxide
Molecular formula:
NA, macromolecular compound
IUPAC Name:
Humic acids and fulvic acids extracted from leonardite, reaction product with formaldehyde, potassium hydrogen sulfite, sodium hydrogen sulfite and potassium hydroxide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA
- Age at study initiation: Young adult (9-10 weeks)
- Weight at study initiation: males 201-236 grams and females 137-184 grams
- Fasting period before study: app. 19 hours
- Housing: singly housed in suspended stainless steel caging with mesh floors.
- Diet (e.g. ad libitum): Purina Rodent Chow #5012
- Water (e.g. ad libitum): Filtered tap water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23 'C (animal room)
- Photoperiod (hrs dark / hrs light): 12 hour cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% w/w solution in distilled water.
- Amount of vehicle (if gavage): calculated based on the initial bodyweights
Doses:
Each animal received 5.000 mg/kg of the test substance, administered using a stainless steel ball-tipped gavage needle attached to an appropriate syringe.
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: The animals were observed for mortality, signs of gross toxicity and behavioral changes at 1 and 3 hours post-dosing and at least once daily thereafter for 14 days. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behaviour pattern. Particular attention was directed to observationis of tremours, convulsions, salivation, diarrhea and coma. Individual bodyweights of the animals were recorded prior to test substance administration (initial) and again on Days 7 and 14 (termination).

- Necropsy of survivors performed: Gross necropsis were performed on all animals. Tissues and organs of the thoracic and abdominal cavities were examined.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
All animals survived
Body weight:
All animals gained weight during the study.
Gross pathology:
No gross abnormalitites

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
All animals survived, gained weight and appeared active and healthy. Apart from all animals exhibiting black colored feces on Day 1, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior. Gross necropsy findings at terminal sacrifice were unremarkable.
Under the conditions of this study, the single dose acute oral LD50 of the substance is greater than 5.000 mg/kg of bodyweight in male and female rats.

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