Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975; date not specified.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, not carried out according to recognised guideline, although results documented.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other: Standard Federal Hazardous Substances Labeling Act tests
Deviations:
yes
Remarks:
Because of the expected low toxicity, one high dose level was used, and the LD50 and LC50's are reported as >(greater than) or <( less than) this value.
Principles of method if other than guideline:
Ten young adult albino rats (Wistar derived) weighing between 200 -300 grams equally distributed into five males and five females were housed in mesh-bottom cages and fasted 24 hours prior to administering a single dose of 20,000 mg/kg of the test material. Food and water were available ad libitum after dosage. The animals were observed daily for 14 days following administration of the test material, and deaths were recorded.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
tricresyl phosphate
IUPAC Name:
tricresyl phosphate
Details on test material:
- Name of test material (as cited in study report): Kronitex TCP tricresyl phosphate
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): Not applicable.
- Substance type: not specified
- Physical state: liquid
- Analytical purity: not specified
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: not specified
- Isomers composition: not specified
- Purity test date: not specified
- Lot/batch No.: Lot SS-578
- Expiration date of the lot/batch: not specified
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: not specified
- Storage condition of test material: not specified
- Other:

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Ten young a dult albino rats (Wistar derived; males and females) weighing between 200 -300 grams equally distributed into five males and five females were housed in mesh-bottom cages and fasted 24 hours prior to administering a single dose of 20,000 mg/kg of the test material. Food and water were available ad libitum after dosage.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Ten young a dult albino rats (Wistar derived; males and females) weighing between 200 -300 grams equally distributed into five males and five females were housed in mesh-bottom cages and fasted 24 hours prior to administering a single dose of 20,000 mg/kg of the test material.

The animals were observed daily for 14 days following administration of the test material , and deaths were recorded.
Doses:
single dose of 20,000 mg/kg of test material
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
As above; animals were dosed with a single dose level of 20,000 mg/kg and then observed for 14 days.
Statistics:
None

Results and discussion

Preliminary study:
None
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Mortality:
Forty percent mortality was observed at the dosage level of 20,000 mg/kg of body weight.
Clinical signs:
Not recorded.
Body weight:
Not recorded.
Gross pathology:
Not recorded.
Other findings:
Not recorded.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
This product has low acute toxicity.
Executive summary:

Kronitex TCP was tested for acute oral toxicity and LD50 was found to be > 20,000 mg/kg body weight. This product is therefore considered to have a low acute toxicity.