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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was carried out according to GLP and USEPA guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: USEPA Guideline
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Fyrol PCF (Lot 4800-3-10)
There are differences in the isomer content from each supplier,but these are not important given that the properties of the isomers are expected to be very similar.
Purity
A typical purity(total of the four isomers)is>97.9%.All testing described in this report is for the commercial product.
Impurities
The impurity profile of the commercial product TCPP is specific to individual manufacturers. It is not likely that the impurities will have had particular influence on any of the results obtained.
Additives
No additives are used.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
corn oil
Details on oral exposure:
no data
Doses:
male rats: 1259, 2000,3162, 4000,4487 and 5000mg/kg
femal rats: 794, 1259, 2000, 3162, 3565, 4000 and 5000mg/kg
No. of animals per sex per dose:
10 male rats and 10 female rats
Control animals:
not specified
Details on study design:
Necropsy of survivors performed: yes
Statistics:
no data

Results and discussion

Preliminary study:
no data
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
4 200 mg/kg bw
Sex:
female
Dose descriptor:
LD50
Effect level:
2 800 mg/kg bw
Mortality:
Male Rats: No deaths occurred at the two lowest dose levels (1259 and 2000 mg/kg). Single oral doses of 3162 and 4000 mg/kg produced 3/10 and 4/10 deaths,respectively. Six animals (out of 10) died at both of the highest dose levels (4487 and 5000 mg/kg).
Female Rats: Ten females were administered single oral doses of 794 and 1259 mg/kg – these produced 0/10 deaths in both cases. Further single oral doses of 2000, 3162, 3565, 4000 and 5000 mg/kg produced 1/10, 3/10, 8/10, 9/10 and 10/10 deaths, respectively.
Clinical signs:
Adverse clinical signs included depression, tremors, lacrimation, salivation, convulsions (females only) and hyperactivity (females only) .
No abnormalities were observed in males at necropsy. Females were found to have bloated caecums and/or stomachs.
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Any other information on results incl. tables

The oral LD50 was 4200 mg/kg in male rats and 2800 mg/kg in female rats. Adverse clinical signs included depression, tremors, lacrimation, salivation, convulsions (females only) and hyperactivity (females only) .

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
This substance shows very low acute oral toxicity.
Executive summary:

Nothing to add in the field.