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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
Study period:
1976-08-09 to 1976-09-16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report with some details misssing as purity of substance, clinical signs of all animals. Study was performed prior to implementation of GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: aqueous liquid
Details on test material:
- Name of test material (as cited in study report): Perfluorhexylaethyljodid
- Molecular formula (if other than submission substance): C6 F13 C2 H4 J
- Physical state: pink aqueous liquid
- Analytical purity: 97 % (GC method) (not in report but according to other archived company data files for this substance from 1976)
- Impurities (identity and concentrations): not applicable
- Lot/batch No.: not applicable

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
The test item was diluted with sesame oil to receive a 25% (v/v) solution. To prevent sedimentation the solution was stirred on a magnetic stirrer prior to application. The animals were starved 16 hours prior to oral treatment. The rats were dosed via oral gavage. Two hours after treatment all animals received food again. Following administration the rats were observed for clinical signs of toxicity for period of 14 days. Animals were weighed weekly. All deathly toxicated animals were dissected and macroscopically examined. The remaining survivors were sacrified in narcosis and then dissected and macroscopcally examined.
Doses:
3200 mg/kg
4000 mg/kg
5000 mg/kg
8000 mg/kg
No. of animals per sex per dose:
10 females
Control animals:
no
Statistics:
LD 50 was estimated with Probit analysis (according to Linder and Weber); confidence interval was estimated acc. to CAVALLI-SFORZA

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
3 868 mg/kg bw
Based on:
test mat.
Mortality:
3200 mg/kg: 0/10
4000 mg/kg: 9/10
5000 mg/kg: 8/10
8000 mg/kg: 10/10
In the 4000 mg/kg dose-group mortality occurred at 350 minutes after treatment in one rat and on days 1 to 2 (six rats), day 3 to 4 (one rat) and day 4 to 5 (one rat) after treatment.
In the 5000 mg/kg dose-group mortality occurred on days 1 to 2 (four rats), day 2 (one rat), days 2 to 3 (2 rats) and day 3 (one rat) after treatment.
In the 8000 mg/kg dose-group mortality occurred at 55, 95, 168, 215 and 325 minutes (one rat at each) after dosing and on day 1 to 2 (4 rats).
Clinical signs:
Deathly toxicated animals showed the following signs prior to exitus: jumping-, or stretch-convulsions and tonic-clonic seizures in abdominal position or in haunched posture. No signs described for the remaining survivors.
Body weight:
Individual bodyweights were recorded on the day of treatment (day 0) and on days 7 and 14. Rats of the 3200 mg/kg dose group and the surviving rats of the 4000 and 5000 mg/kg dose-groups showed expected gain in bodyweight over the study period.
Gross pathology:
All deathly intoxicated animals were dissected and macroscopically examined. The remaining survivors were sacrificed in narcosis and then dissected and macroscopically examined.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based on the results of this study the acute oral median lethal dose (LD50) of the test material to the Wistar strain rat (females) was found to be 3868 mg/kg body weight.
Executive summary:

For the acute oral toxicity study a group of ten fasted animals (females) was given a single oral dose of test material via oral gavage at a dose level of 3200, 4000, 5000 and 8000 mg/kg body weight. Sesame oil was chosen as vehicle. No death occurred in the 3200 mg/kg dose group. In the 4000 mg/kg dose group 9 of 10 animals died, in the 5000 mg/kg dose group 8 of 10 animals died and in the 8000 mg/kg dose group 10 of 10 animals died. Rats of the 3200 mg/kg dose group and the surviving rats of the 4000 and 5000 mg/kg dose-groups showed expected gain in bodyweight over the study period. The following signs of toxicity were observed on rats that died: jumping-, or stretch-convulsions and tonic-clonic seizures in abdominal position or in haunched posture. No signs are described for the remaining survivors.

Based on the results of this study the acute oral median lethal dose (LD50) of the test material to the Wistar strain rat (females) was found to be 3868 mg/kg body weight.